xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05982860</url>
    </required_header>
    <id_info>
      <org_study_id>BARTU 01</org_study_id>
      <nct_id>NCT05982860</nct_id>
    </id_info>
    <brief_title>The Effects of the MIND Diet on Oxidative Stress, Inflammation and Neurodegenerative Risk Biomarkers</brief_title>
    <official_title>Evaluation of the Effects of the MIND Diet on Oxidative Stress, Inflammation and Neurodegenerative Risk Biomarkers in American Football Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bartu Eren Güneşliol</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duzce University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        American football is a high-contact sport, also known as a collision sport. American football&#xD;
        players are exposed to various magnitudes and frequencies of head impacts throughout the&#xD;
        season. Accordingly, during the American football season, there is an increase in biomarkers&#xD;
        that may be associated with brain damage and the risk of developing neurodegenerative&#xD;
        diseases later in life. In addition, oxidative stress and inflammation can also increase in&#xD;
        athletes during the American football season. This study was planned with the thought that&#xD;
        the MIND diet, which is beneficial for brain health with its antioxidant and&#xD;
        anti-inflammatory effects, may have positive effects on oxidative stress, inflammation and&#xD;
        neurodegenerative risk biomarkers in American football players.&#xD;
  &#xD;
        The goal of this clinical trial is to examine the effects of the MIND diet on oxidative&#xD;
        stress, inflammation and neurodegenerative risk biomarkers in American football players. The&#xD;
        main question it aims to answer are:&#xD;
  &#xD;
        • [Question] Does the MIND diet lowers or reduce the levels of oxidative stress, inflammation&#xD;
        and neurodegenerative risk biomarkers in American football players?&#xD;
  &#xD;
        Participants will be randomized into 2 groups MIND diet and control group. The current diet&#xD;
        of the players in the control group will not be interfered with during the competition&#xD;
        period, but the current nutrition of the players in the MIND diet group will be adapted to&#xD;
        the MIND diet according to the food groups in the MIND diet components and their consumption&#xD;
        frequencies.&#xD;
  &#xD;
        The players in the MIND diet group will be asked to include the food groups in the MIND diet&#xD;
        in their diet in accordance with their consumption frequency.&#xD;
  &#xD;
        Researchers will compare the MIND diet and control groups to see if the MIND diet improves&#xD;
        oxidative stress, inflammation and neurodegenerative risk biomarkers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        American football is one of the contact sports with the highest risk in terms of exposure to&#xD;
        repeated head impacts and the formation of neurodegenerative diseases that negatively affect&#xD;
        the quality of life in the later stage of life. According to studies conducted in recent&#xD;
        years, these athletes have a high risk of developing neurodegenerative diseases such as&#xD;
        Alzheimer's, amyotrophic lateral sclerosis (ALS) and chronic traumatic encephalopathy (CTE)&#xD;
        later in life. It has been reported that there are increases in the levels of oxidative&#xD;
        stress, inflammation and neurodegenerative risk biomarkers and that some other biomarkers&#xD;
        (such as BDNF, zonulin, telomere length, etc.) that may be associated with these may be&#xD;
        adversely affected in American football players. It is necessary to develop new approaches to&#xD;
        determine the preventive factors against the risk of neurodegenerative diseases that may&#xD;
        occur in the later years of life due to contact sports such as American football. The&#xD;
        Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has antioxidant&#xD;
        (vitamins, flavonoids, phytosterols, minerals, terpenes and phenols) and anti-inflammatory&#xD;
        (oleic acid, polyphenols and unsaturated fatty acids) properties that are thought to be&#xD;
        effective in improving oxidative stress, inflammation and neurodegenerative risk biomarkers.&#xD;
        The MIND diet can also reduce intestinal permeability with its abundant fiber content&#xD;
        (prebiotic effect). It has been reported that the supplementation of some nutrients&#xD;
        (docosahexaenoic acid, eicosapentaenoic acid, etc.) that have an important place in the&#xD;
        composition of the MIND diet in this group of athletes has a positive effect on some of these&#xD;
        biomarkers. However, the studies in the literature are limited, and there is no study&#xD;
        involving the MIND diet in American football players. This study was planned considering that&#xD;
        the MIND diet may have positive effects on oxidative stress, inflammation, and&#xD;
        neurodegenerative risk biomarkers in American football players, who are exposed to repetitive&#xD;
        head impacts as a nature of this contact sport.&#xD;
  &#xD;
        American football players playing in the pro league will be included in this study. The&#xD;
        sample size was calculated using the G*Power V. 3.1.9.6 program. This study will include two&#xD;
        groups and two measurements. Accordingly, a total of 30 athletes, 15 in each group, with 95%&#xD;
        confidence (1-α), 95% test power (1-β) and f=0.6 effect size; with 80% confidence (1-α), 80%&#xD;
        test power (1-β) and f=0.6 effect size, a total of 20 athletes, 10 in each group, should be&#xD;
        included.&#xD;
  &#xD;
        At the beginning of the research, a face-to-face questionnaire will be used to question the&#xD;
        athletes' American football history and player positions, socio-demographics, general health&#xD;
        and nutritional habits. Before the start of the study, a 7-day food consumption record will&#xD;
        be taken from the athletes. MIND scores will be questioned before the study and every week&#xD;
        till the end of the study according to the frequency of food consumption in the MIND&#xD;
        composition scale. It will be used to assess participants' adherence to the MIND diet.&#xD;
        Accordingly, the MIND diet components include ten food groups (green leafy vegetables, other&#xD;
        vegetables, nuts, berries, bean types, whole grains, seafood, poultry, olive oil, and wine)&#xD;
        that are healthy for the brain. There are also five food groups (red meat, butter and&#xD;
        margarine, cheese, pastries and sweets and fried / fast food / fast food) that are considered&#xD;
        unhealthy. Frequencies of food consumption (daily, weekly, monthly) are questioned according&#xD;
        to whether these 10 food groups specified in the template are preferred based on portion and&#xD;
        meal or as primary, and as a result, scoring is made as 0, 0.5 and 1 points for each food&#xD;
        group. The highest score is 15 points. Because the MIND diet template does not have specific&#xD;
        scores for diet adherence, below the median score (7.5) will be considered low adherence.&#xD;
        According to the MIND diet composition scale, those with a MIND diet score of &lt;7.5 points&#xD;
        will be included in the study, while those with a score of ≥7.5 will be excluded from the&#xD;
        study. At the beginning of the study, body composition measurements (anthropometric&#xD;
        measurements and bioelectrical impedance analysis) will be taken from the athletes along with&#xD;
        the Pittsburgh sleep quality index scale scores, diet inflammatory index, and the World&#xD;
        Health Organization quality of life scale-short form. Oxidative stress, inflammation,&#xD;
        neurodegenerative risk and other associated biomarkers will be analyzed in blood samples.&#xD;
  &#xD;
        Athletes will be randomized into two groups; MIND diet and control group. The players in the&#xD;
        control group will sustain their habitual nutrition, while the current nutrition of the&#xD;
        players in the MIND diet group will be adapted to the MIND diet according to the food groups&#xD;
        in the MIND diet components and their consumption frequencies. In this context, the players&#xD;
        will be informed about the general characteristics of the MIND diet and its importance in&#xD;
        terms of their health. To help the participants in this regard, information will be given&#xD;
        about the changes in the size and amount of foods and their portions in general with the&#xD;
        &quot;Meal and Food Photo Catalogue&quot;. As a result of the interviews with the coaches and&#xD;
        experienced players, it was learned that the majority of the players did not consume/can't&#xD;
        access the foods such as wine, berries, and fish included in the MIND diet template.&#xD;
        Therefore, these foods, which are the main components of the MIND diet, will be provided by&#xD;
        the researcher/project by the recommended frequencies. However, since wine consumption is not&#xD;
        frequently preferred in our country due to religious and socio-cultural reasons,&#xD;
        ''hardaliye'' (100 mL/day), which is easy to consume and has similar nutritional values to&#xD;
        wine (resveratrol and ORAC), will be provided. Red forest fruits will be supplied in 2&#xD;
        portions/week, and fish (tons) in 1 portion/week. Before the study, participants assigned to&#xD;
        the MIND diet group were provided with brochures, information, presentations, etc. so that&#xD;
        they could adapt to the MIND diet. Participants in this group will be supported during the&#xD;
        study period to increase their adherence to the MIND diet with information and suggestions&#xD;
        via phone, mail, WhatsApp groups, etc. Those in the MIND diet group with an overall mean MIND&#xD;
        score of &lt;7.5 at mid- or end-of-study will be excluded from the study. Athletes in the&#xD;
        control group with an overall mean MIND score of ≥7.5 at the mid- or end-of-study will be&#xD;
        excluded from the study. Since all teams will participate in the same number of competitions&#xD;
        and the group matches will last approximately nine weeks, the follow-up time has been&#xD;
        determined as nine weeks. At the end of the nine-week follow-up, all parameters evaluated at&#xD;
        the beginning of the study will be taken again, and the last values will be compared with the&#xD;
        previous values.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 23, 2023</start_date>
    <completion_date type="Anticipated">September 3, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 27, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This study was planned as a randomized controlled trial.</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tau protein</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NfL (Neurofilament light polypeptide)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>S100B protein</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BDNF (Brain Derived Neurotrophic Factor)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker associated with an important role in reducing neurodegenerative risk and in cellular events occurring in restorative processes against damage that may lead to oxidative stress and neuroinflammation in contact sports such as American football.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Telomere</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>Due to increased oxidative stress and inflammation, the erosion of telomeres, a biomarker of aging, may occur more rapidly. Damaged mitochondria in American football players can trigger an increase in oxidative stress and inflammation levels, which are the most important triggers of the mechanisms of neurodegenerative disorders, and lead to cell death. Telomere shortening is associated with premature cellular senescence and cell death and is thought to be a biomarker for neurodegenerative damage at the cellular level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Zonulin</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>Low serum zonulin levels appear to be a biomarker for increased intestinal permeability and disruption of gastrointestinal barrier integrity. Increased intestinal permeability and disruption of intestinal barrier integrity may also increase already existing neuroinflammation by increasing inflammation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NOX2 (NADPH oxidase)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>8-OHdG (8- hydroxy-2-deoxyguanosine)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>F2-isoprostanes (F2-isoPs)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hs-CRP (High-sensitivity C-reactive protein)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IL-6 (Interleukin 6)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>TNF-α (Tumor necrosis factor alpha)</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep quality score</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life score</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>The quality of life will be assessed via the questionnaire of The World Health Organization quality of life (WHOQOL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary inflammatory index (DII) score</measure>
      <time_frame>Before and after the 9-week research.</time_frame>
      <description>Dietary inflammatory index will be calculated based on formula originally developed by Shivappa et al. (2014).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Neurodegeneration</condition>
    <condition>Inflammation</condition>
    <condition>Oxidative Stress</condition>
    <condition>Diet, Healthy</condition>
    <condition>Diet Habit</condition>
    <condition>Nutrition, Healthy</condition>
    <arm_group>
      <arm_group_label>Control (n:18)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Players in this group will not be given any nutritional advice/intervention. They will maintain their usual eating habits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MIND diet (n:18)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Players in this group will be asked to include the food groups in the MIND diet in their diet in accordance with their consumption frequency. As a result of the interviews with the coaches and experienced athletes, it was learned that the majority of the athletes did not consume the foods such as wine, berries, and fish included in the MIND diet template. Therefore, these foods, which are the main components of the MIND diet, will be provided by the researcher/project in accordance with the recommended frequencies. However, since wine consumption is not frequently preferred in our country due to religious and socio-cultural reasons, ''hardaliye'', a fermented grape juice (100 mL/day), which is easy to consume and has similar nutritional values to wine (resveratrol and ORAC), will be provided. Berries will be supplied in 2 portions/week, and fish (tons) in 1 portion/week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MIND diet</intervention_name>
      <description>Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has been established by Morris et al. (2015) to improve brain health, and reduce the risk or slow progression of neurodegenerative diseases. In this diet model, which is similar to the Mediterranean diet, the diet score changes according to the frequency of consumption of some foods. The more consumption of foods such as green leafy vegetables, other vegetables, berries, nuts, whole grains, fish (not fried), beans, poultry (not fried), and the limited consumption of butter/margarine, cheese, red meat and products, fast fried foods, and pastries &amp; sweets ensure more score. Also, regular consumption of wine (1 glass/d) and using olive oil as primary oil in meals increases the score. Berries, fish, and hardaliye (instead of wine) will be supplied to players as well as recommendations for consumption frequencies of food components in MIND diet to increase total score.</description>
      <arm_group_label>MIND diet (n:18)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having played American football for at least 2 years&#xD;
  &#xD;
            -  ≥18 years old&#xD;
  &#xD;
            -  Having had a MIND diet score of &lt; 7.5 points&#xD;
  &#xD;
            -  Not having any family or cohabitants following the MIND diet&#xD;
  &#xD;
            -  Providing written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years old&#xD;
  &#xD;
            -  Having had a MIND diet score of ≥7.5 points&#xD;
  &#xD;
            -  History of concussion diagnosed in the last 6 months&#xD;
  &#xD;
            -  use of anti-inflammatory or antioxidant drugs (&gt;20 days)&#xD;
  &#xD;
            -  food allergy&#xD;
  &#xD;
            -  A state of injury that is unable to carry out the study&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Since only men play American football, our study is based on male gender.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bartu Gunesliol, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duzce University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nilufer Tek, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Asiye Dikmen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Duzce University</name>
        <address>
          <city>Duzce</city>
          <zip>81620</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Duzce University</investigator_affiliation>
      <investigator_full_name>Bartu Eren Güneşliol</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>MIND diet</keyword>
    <keyword>sports nutrition</keyword>
    <keyword>Dietary habits</keyword>
    <keyword>Neurodegeneration</keyword>
    <keyword>Inflammation</keyword>
    <keyword>Oxidative stress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Inflammation</mesh_term>
      <mesh_term>Nerve Degeneration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>It is considered that the scientific outputs of the study could be shared upon request without personal data. Any participants' private data will never be shared. Personal private data protection law will be complied with.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>It is expected that access to the scientific outputs of this research will be provided from 2025 and will be open until 2028.</ipd_time_frame>
      <ipd_access_criteria>It is planned to be accessible only to international academic staff and researchers.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05982860
  org study id: BARTU 01
  nct id: NCT05982860
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  American football is a high-contact sport, also known as a collision sport. American football
        players are exposed to various magnitudes and frequencies of head impacts throughout the
        season. Accordingly, during the American football season, there is an increase in biomarkers
        that may be associated with brain damage and the risk of developing neurodegenerative
        diseases later in life. In addition, oxidative stress and inflammation can also increase in
        athletes during the American football season. This study was planned with the thought that
        the MIND diet, which is beneficial for brain health with its antioxidant and
        anti-inflammatory effects, may have positive effects on oxidative stress, inflammation and
        neurodegenerative risk biomarkers in American football players.
  
        The goal of this clinical trial is to examine the effects of the MIND diet on oxidative
        stress, inflammation and neurodegenerative risk biomarkers in American football players. The
        main question it aims to answer are:
  
        • [Question] Does the MIND diet lowers or reduce the levels of oxidative stress, inflammation
        and neurodegenerative risk biomarkers in American football players?
  
        Participants will be randomized into 2 groups MIND diet and control group. The current diet
        of the players in the control group will not be interfered with during the competition
        period, but the current nutrition of the players in the MIND diet group will be adapted to
        the MIND diet according to the food groups in the MIND diet components and their consumption
        frequencies.
  
        The players in the MIND diet group will be asked to include the food groups in the MIND diet
        in their diet in accordance with their consumption frequency.
  
        Researchers will compare the MIND diet and control groups to see if the MIND diet improves
        oxidative stress, inflammation and neurodegenerative risk biomarkers.
  American football is one of the contact sports with the highest risk in terms of exposure to
        repeated head impacts and the formation of neurodegenerative diseases that negatively affect
        the quality of life in the later stage of life. According to studies conducted in recent
        years, these athletes have a high risk of developing neurodegenerative diseases such as
        Alzheimer's, amyotrophic lateral sclerosis (ALS) and chronic traumatic encephalopathy (CTE)
        later in life. It has been reported that there are increases in the levels of oxidative
        stress, inflammation and neurodegenerative risk biomarkers and that some other biomarkers
        (such as BDNF, zonulin, telomere length, etc.) that may be associated with these may be
        adversely affected in American football players. It is necessary to develop new approaches to
        determine the preventive factors against the risk of neurodegenerative diseases that may
        occur in the later years of life due to contact sports such as American football. The
        Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has antioxidant
        (vitamins, flavonoids, phytosterols, minerals, terpenes and phenols) and anti-inflammatory
        (oleic acid, polyphenols and unsaturated fatty acids) properties that are thought to be
        effective in improving oxidative stress, inflammation and neurodegenerative risk biomarkers.
        The MIND diet can also reduce intestinal permeability with its abundant fiber content
        (prebiotic effect). It has been reported that the supplementation of some nutrients
        (docosahexaenoic acid, eicosapentaenoic acid, etc.) that have an important place in the
        composition of the MIND diet in this group of athletes has a positive effect on some of these
        biomarkers. However, the studies in the literature are limited, and there is no study
        involving the MIND diet in American football players. This study was planned considering that
        the MIND diet may have positive effects on oxidative stress, inflammation, and
        neurodegenerative risk biomarkers in American football players, who are exposed to repetitive
        head impacts as a nature of this contact sport.
  
        American football players playing in the pro league will be included in this study. The
        sample size was calculated using the G*Power V. 3.1.9.6 program. This study will include two
        groups and two measurements. Accordingly, a total of 30 athletes, 15 in each group, with 95%
        confidence (1-α), 95% test power (1-β) and f=0.6 effect size; with 80% confidence (1-α), 80%
        test power (1-β) and f=0.6 effect size, a total of 20 athletes, 10 in each group, should be
        included.
  
        At the beginning of the research, a face-to-face questionnaire will be used to question the
        athletes' American football history and player positions, socio-demographics, general health
        and nutritional habits. Before the start of the study, a 7-day food consumption record will
        be taken from the athletes. MIND scores will be questioned before the study and every week
        till the end of the study according to the frequency of food consumption in the MIND
        composition scale. It will be used to assess participants' adherence to the MIND diet.
        Accordingly, the MIND diet components include ten food groups (green leafy vegetables, other
        vegetables, nuts, berries, bean types, whole grains, seafood, poultry, olive oil, and wine)
        that are healthy for the brain. There are also five food groups (red meat, butter and
        margarine, cheese, pastries and sweets and fried / fast food / fast food) that are considered
        unhealthy. Frequencies of food consumption (daily, weekly, monthly) are questioned according
        to whether these 10 food groups specified in the template are preferred based on portion and
        meal or as primary, and as a result, scoring is made as 0, 0.5 and 1 points for each food
        group. The highest score is 15 points. Because the MIND diet template does not have specific
        scores for diet adherence, below the median score (7.5) will be considered low adherence.
        According to the MIND diet composition scale, those with a MIND diet score of <7.5 points
        will be included in the study, while those with a score of ≥7.5 will be excluded from the
        study. At the beginning of the study, body composition measurements (anthropometric
        measurements and bioelectrical impedance analysis) will be taken from the athletes along with
        the Pittsburgh sleep quality index scale scores, diet inflammatory index, and the World
        Health Organization quality of life scale-short form. Oxidative stress, inflammation,
        neurodegenerative risk and other associated biomarkers will be analyzed in blood samples.
  
        Athletes will be randomized into two groups; MIND diet and control group. The players in the
        control group will sustain their habitual nutrition, while the current nutrition of the
        players in the MIND diet group will be adapted to the MIND diet according to the food groups
        in the MIND diet components and their consumption frequencies. In this context, the players
        will be informed about the general characteristics of the MIND diet and its importance in
        terms of their health. To help the participants in this regard, information will be given
        about the changes in the size and amount of foods and their portions in general with the
        "Meal and Food Photo Catalogue". As a result of the interviews with the coaches and
        experienced players, it was learned that the majority of the players did not consume/can't
        access the foods such as wine, berries, and fish included in the MIND diet template.
        Therefore, these foods, which are the main components of the MIND diet, will be provided by
        the researcher/project by the recommended frequencies. However, since wine consumption is not
        frequently preferred in our country due to religious and socio-cultural reasons,
        ''hardaliye'' (100 mL/day), which is easy to consume and has similar nutritional values to
        wine (resveratrol and ORAC), will be provided. Red forest fruits will be supplied in 2
        portions/week, and fish (tons) in 1 portion/week. Before the study, participants assigned to
        the MIND diet group were provided with brochures, information, presentations, etc. so that
        they could adapt to the MIND diet. Participants in this group will be supported during the
        study period to increase their adherence to the MIND diet with information and suggestions
        via phone, mail, WhatsApp groups, etc. Those in the MIND diet group with an overall mean MIND
        score of <7.5 at mid- or end-of-study will be excluded from the study. Athletes in the
        control group with an overall mean MIND score of ≥7.5 at the mid- or end-of-study will be
        excluded from the study. Since all teams will participate in the same number of competitions
        and the group matches will last approximately nine weeks, the follow-up time has been
        determined as nine weeks. At the end of the nine-week follow-up, all parameters evaluated at
        the beginning of the study will be taken again, and the last values will be compared with the
        previous values.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study was planned as a randomized controlled trial.
  primary purpose: Screening
  masking: None (Open Label)
  measure: Tau protein
  time frame: Before and after the 9-week research.
  description: A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.
  measure: NfL (Neurofilament light polypeptide)
  time frame: Before and after the 9-week research.
  description: A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.
  measure: S100B protein
  time frame: Before and after the 9-week research.
  description: A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.
  measure: BDNF (Brain Derived Neurotrophic Factor)
  time frame: Before and after the 9-week research.
  description: A biomarker associated with an important role in reducing neurodegenerative risk and in cellular events occurring in restorative processes against damage that may lead to oxidative stress and neuroinflammation in contact sports such as American football.
  measure: Telomere
  time frame: Before and after the 9-week research.
  description: Due to increased oxidative stress and inflammation, the erosion of telomeres, a biomarker of aging, may occur more rapidly. Damaged mitochondria in American football players can trigger an increase in oxidative stress and inflammation levels, which are the most important triggers of the mechanisms of neurodegenerative disorders, and lead to cell death. Telomere shortening is associated with premature cellular senescence and cell death and is thought to be a biomarker for neurodegenerative damage at the cellular level.
  measure: Zonulin
  time frame: Before and after the 9-week research.
  description: Low serum zonulin levels appear to be a biomarker for increased intestinal permeability and disruption of gastrointestinal barrier integrity. Increased intestinal permeability and disruption of intestinal barrier integrity may also increase already existing neuroinflammation by increasing inflammation.
  measure: NOX2 (NADPH oxidase)
  time frame: Before and after the 9-week research.
  description: A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.
  measure: 8-OHdG (8- hydroxy-2-deoxyguanosine)
  time frame: Before and after the 9-week research.
  description: A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.
  measure: F2-isoprostanes (F2-isoPs)
  time frame: Before and after the 9-week research.
  description: A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.
  measure: hs-CRP (High-sensitivity C-reactive protein)
  time frame: Before and after the 9-week research.
  description: A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.
  measure: IL-6 (Interleukin 6)
  time frame: Before and after the 9-week research.
  description: A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.
  measure: TNF-α (Tumor necrosis factor alpha)
  time frame: Before and after the 9-week research.
  description: A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.
  measure: Sleep quality score
  time frame: Before and after the 9-week research.
  description: The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality.
  measure: Quality of life score
  time frame: Before and after the 9-week research.
  description: The quality of life will be assessed via the questionnaire of The World Health Organization quality of life (WHOQOL).
  measure: Dietary inflammatory index (DII) score
  time frame: Before and after the 9-week research.
  description: Dietary inflammatory index will be calculated based on formula originally developed by Shivappa et al. (2014).
  arm group label: Control (n:18)
  arm group type: No Intervention
  description: Players in this group will not be given any nutritional advice/intervention. They will maintain their usual eating habits.
  arm group label: MIND diet (n:18)
  arm group type: Experimental
  description: Players in this group will be asked to include the food groups in the MIND diet in their diet in accordance with their consumption frequency. As a result of the interviews with the coaches and experienced athletes, it was learned that the majority of the athletes did not consume the foods such as wine, berries, and fish included in the MIND diet template. Therefore, these foods, which are the main components of the MIND diet, will be provided by the researcher/project in accordance with the recommended frequencies. However, since wine consumption is not frequently preferred in our country due to religious and socio-cultural reasons, ''hardaliye'', a fermented grape juice (100 mL/day), which is easy to consume and has similar nutritional values to wine (resveratrol and ORAC), will be provided. Berries will be supplied in 2 portions/week, and fish (tons) in 1 portion/week.
  intervention type: Behavioral
  intervention name: MIND diet
  description: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has been established by Morris et al. (2015) to improve brain health, and reduce the risk or slow progression of neurodegenerative diseases. In this diet model, which is similar to the Mediterranean diet, the diet score changes according to the frequency of consumption of some foods. The more consumption of foods such as green leafy vegetables, other vegetables, berries, nuts, whole grains, fish (not fried), beans, poultry (not fried), and the limited consumption of butter/margarine, cheese, red meat and products, fast fried foods, and pastries & sweets ensure more score. Also, regular consumption of wine (1 glass/d) and using olive oil as primary oil in meals increases the score. Berries, fish, and hardaliye (instead of wine) will be supplied to players as well as recommendations for consumption frequencies of food components in MIND diet to increase total score.
  arm group label: MIND diet (n:18)
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Since only men play American football, our study is based on male gender.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bartu Gunesliol, Master
  role: Principal Investigator
  affiliation: Duzce University
  last name: Nilufer Tek, PhD
  role: Principal Investigator
  affiliation: Gazi University
  last name: Asiye Dikmen, PhD
  role: Principal Investigator
  affiliation: Gazi University
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Duzce University
  investigator full name: Bartu Eren Güneşliol
  investigator title: Research Assistant
  mesh term: Inflammation
  mesh term: Nerve Degeneration
  sharing ipd: Yes
  ipd description: It is considered that the scientific outputs of the study could be shared upon request without personal data. Any participants' private data will never be shared. Personal private data protection law will be complied with.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: It is expected that access to the scientific outputs of this research will be provided from 2025 and will be open until 2028.
  ipd access criteria: It is planned to be accessible only to international academic staff and researchers.