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/NCT06008886</url>
    </required_header>
    <id_info>
      <org_study_id>20/2023</org_study_id>
      <nct_id>NCT06008886</nct_id>
    </id_info>
    <brief_title>Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes</brief_title>
    <acronym>OMNIVEG</acronym>
    <official_title>Effect of a Vegan Diet Versus a Mediterrean Diet on Performance, Cardiorespiratory Fitness, Metabolic Health, Immune Status, and Environmental Impact in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Francisco de Vitoria</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Francisco de Vitoria</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>
        This study aimed to evaluate the effect of a vegan diet (supplemented with vitamin B12) and&#xD;
        an mediterranean diet on performance, cardiorespiratory fitness, metabolic health, immune&#xD;
        status, and environmental impact in healthy adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        OMNIVEG is a controlled crossover trial. Initially, registered dietitians conducted an&#xD;
        assessment of participants' lifestyles in a preliminary session. Qualified nutritionists then&#xD;
        developed personalized diets for each participant in accordance with the recommendations of&#xD;
        the International Society of Sports Nutrition (ISSN). These diets followed specific&#xD;
        guidelines, including a daily intake of 3-5 g of carbohydrates per kilogram of body weight,&#xD;
        1.4-2.0 g of protein per kilogram of body weight, and 0.5-1.5 g of fat per kilogram of body&#xD;
        weight.&#xD;
  &#xD;
        Both the mediterranean diet and vegan diets prescribed to the participants were isocaloric,&#xD;
        with similar distributions of macronutrients. The primary difference between the two&#xD;
        interventions was the source of food: the vegan diet exclusively comprised plant-based foods,&#xD;
        while the omnivorous diet included foods of both animal and plant sources. In the case of the&#xD;
        omnivorous diet, 60% of the total protein intake was derived from animal sources (mainly from&#xD;
        fish, white meat, low-fat dairy and eggs).&#xD;
  &#xD;
        As part of the vegan diet, participants were instructed to take 1000 µg of cyanocobalamin (a&#xD;
        form of vitamin B12) twice a week from Harrison Sport Nutrition, Granada, Spain. This&#xD;
        supplementation aimed to ensure adequate vitamin B12 intake, which is essential for&#xD;
        individuals following a vegan diet.&#xD;
  &#xD;
        Throughout the study period, participants were advised to maintain their initial physical&#xD;
        exercise frequency and volume to maintain consistency and avoid confounding variables. To&#xD;
        ensure standardized measurements, all tests were conducted in the same laboratory, employing&#xD;
        identical testing devices, and supervised by the same group of researchers. This approach&#xD;
        aimed to minimize experimental variability and improve the reliability of the study's&#xD;
        results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">September 4, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiorespiratory fitness</measure>
      <time_frame>4 weeks</time_frame>
      <description>Cardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Metabolic health</measure>
      <time_frame>4 weeks</time_frame>
      <description>Metabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Performance</measure>
      <time_frame>4 weeks</time_frame>
      <description>Performance was measured using FATmax (g/min).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Performance</measure>
      <time_frame>4 weeks</time_frame>
      <description>Performance was measured using countermovement (CMJ) (W) and squat jump (SJ).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Performance</measure>
      <time_frame>4 weeks</time_frame>
      <description>Performance was measured using squat jump (SJ) (W)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Environmental impact assessment</measure>
      <time_frame>4 weeks</time_frame>
      <description>Environmental impact was measured using Global-warming potential-100</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Inmune status</measure>
      <time_frame>4 weeks</time_frame>
      <description>Inmune status was measured using lymphocyte levels (109/L )</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Performance</measure>
      <time_frame>4 weeks</time_frame>
      <description>Performance was measured using handgrip</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metabolic health</measure>
      <time_frame>4 weeks</time_frame>
      <description>Metabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inmune status</measure>
      <time_frame>4 weeks</time_frame>
      <description>Inmune status was measured using monocyte, eosinophils and neutrophils levels (10^9/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Environmental impact assessment</measure>
      <time_frame>4 weeks</time_frame>
      <description>Environmental impact was measured using blue water footprint and land use.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Cardiometabolic Syndrome</condition>
    <arm_group>
      <arm_group_label>Vegan diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Vegan diet all foods included were of plant sources. During the vegan diet, the participants took 1000 µg of cyanocobalamin twice a week (Harrison Sport Nutrition, Granada, Spain)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mediterranean diet</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the case of the mediterranean diet, foods of animal sources were also included (animal protein accounted for 60% of total protein intake). In this diet there was a predominance of plant foods; moderate to low consumption of fish, white meat, low-fat dairy and eggs; and very low consumption of red and processed meats, butter, full-fat dairy and sweets.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Vegan diet</intervention_name>
      <description>Normocaloric diet based solely on foods of plant sources.</description>
      <arm_group_label>Vegan diet</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mediterranean diet</intervention_name>
      <description>Diet with a predominance of plant foods fruits, vegetables, whole grains, nuts and legumes); moderate to low consumption of fish, white meat, low-fat dairy and eggs; and very low consumption of red and processed meats, butter, full-fat dairy and sweets.</description>
      <arm_group_label>Mediterranean diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men.&#xD;
  &#xD;
            -  Aged between 18-40 years.&#xD;
  &#xD;
            -  Physically active according to the recommendations of the World Health Organization&#xD;
               (WHO).&#xD;
  &#xD;
            -  Body Mass Index (BMI) between 18.5-24.9 kg/m2.&#xD;
  &#xD;
            -  No tobacco use.&#xD;
  &#xD;
            -  No or low alcohol consumption and no orthopedic limitations that would interfere with&#xD;
               the performance of the study tests.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Chronic diseases that impair athletic performance (cardiovascular, metabolic,&#xD;
               gastrointestinal, respiratory) within the last six months.&#xD;
  &#xD;
            -  Musculoskeletal disease within the last six months.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Miguel López Moreno, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidad Francisco de Vitoria</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Francisco de Vitoria University</name>
        <address>
          <city>Madrid</city>
          <zip>28223</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Francisco de Vitoria</investigator_affiliation>
      <investigator_full_name>Miguel López Moreno</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Plant-Based Diet</keyword>
    <keyword>Environmental Impact</keyword>
    <keyword>Cardiorespiratory Fitness</keyword>
    <keyword>Performance</keyword>
    <keyword>Metabolic Health</keyword>
    <keyword>Mediterranean diet</keyword>
    <keyword>Vegan diet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metabolic Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06008886
  org study id: 20/2023
  nct id: NCT06008886
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to evaluate the effect of a vegan diet (supplemented with vitamin B12) and
        an mediterranean diet on performance, cardiorespiratory fitness, metabolic health, immune
        status, and environmental impact in healthy adults.
  OMNIVEG is a controlled crossover trial. Initially, registered dietitians conducted an
        assessment of participants' lifestyles in a preliminary session. Qualified nutritionists then
        developed personalized diets for each participant in accordance with the recommendations of
        the International Society of Sports Nutrition (ISSN). These diets followed specific
        guidelines, including a daily intake of 3-5 g of carbohydrates per kilogram of body weight,
        1.4-2.0 g of protein per kilogram of body weight, and 0.5-1.5 g of fat per kilogram of body
        weight.
  
        Both the mediterranean diet and vegan diets prescribed to the participants were isocaloric,
        with similar distributions of macronutrients. The primary difference between the two
        interventions was the source of food: the vegan diet exclusively comprised plant-based foods,
        while the omnivorous diet included foods of both animal and plant sources. In the case of the
        omnivorous diet, 60% of the total protein intake was derived from animal sources (mainly from
        fish, white meat, low-fat dairy and eggs).
  
        As part of the vegan diet, participants were instructed to take 1000 µg of cyanocobalamin (a
        form of vitamin B12) twice a week from Harrison Sport Nutrition, Granada, Spain. This
        supplementation aimed to ensure adequate vitamin B12 intake, which is essential for
        individuals following a vegan diet.
  
        Throughout the study period, participants were advised to maintain their initial physical
        exercise frequency and volume to maintain consistency and avoid confounding variables. To
        ensure standardized measurements, all tests were conducted in the same laboratory, employing
        identical testing devices, and supervised by the same group of researchers. This approach
        aimed to minimize experimental variability and improve the reliability of the study's
        results.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cardiorespiratory fitness
  time frame: 4 weeks
  description: Cardiorespiratory fitness was measured using Maximal oxygen uptake (VO2max).
  measure: Metabolic health
  time frame: 4 weeks
  description: Metabolic health was measured using serum total cholesterol (TC), cholesterol-LDL (LDL-c) and colesterol-HDL (HDL-c)
  measure: Performance
  time frame: 4 weeks
  description: Performance was measured using FATmax (g/min).
  measure: Performance
  time frame: 4 weeks
  description: Performance was measured using countermovement (CMJ) (W) and squat jump (SJ).
  measure: Performance
  time frame: 4 weeks
  description: Performance was measured using squat jump (SJ) (W)
  measure: Environmental impact assessment
  time frame: 4 weeks
  description: Environmental impact was measured using Global-warming potential-100
  measure: Inmune status
  time frame: 4 weeks
  description: Inmune status was measured using lymphocyte levels (109/L )
  measure: Performance
  time frame: 4 weeks
  description: Performance was measured using handgrip
  measure: Metabolic health
  time frame: 4 weeks
  description: Metabolic health was measured using systolic blood pressure (SBP) and diastolic blood pressure (DBP).
  measure: Inmune status
  time frame: 4 weeks
  description: Inmune status was measured using monocyte, eosinophils and neutrophils levels (10^9/L)
  measure: Environmental impact assessment
  time frame: 4 weeks
  description: Environmental impact was measured using blue water footprint and land use.
  arm group label: Vegan diet
  arm group type: Experimental
  description: Vegan diet all foods included were of plant sources. During the vegan diet, the participants took 1000 µg of cyanocobalamin twice a week (Harrison Sport Nutrition, Granada, Spain)
  arm group label: Mediterranean diet
  arm group type: Active Comparator
  description: In the case of the mediterranean diet, foods of animal sources were also included (animal protein accounted for 60% of total protein intake). In this diet there was a predominance of plant foods; moderate to low consumption of fish, white meat, low-fat dairy and eggs; and very low consumption of red and processed meats, butter, full-fat dairy and sweets.
  intervention type: Behavioral
  intervention name: Vegan diet
  description: Normocaloric diet based solely on foods of plant sources.
  arm group label: Vegan diet
  intervention type: Behavioral
  intervention name: Mediterranean diet
  description: Diet with a predominance of plant foods fruits, vegetables, whole grains, nuts and legumes); moderate to low consumption of fish, white meat, low-fat dairy and eggs; and very low consumption of red and processed meats, butter, full-fat dairy and sweets.
  arm group label: Mediterranean diet
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Miguel López Moreno, Phd
  role: Principal Investigator
  affiliation: Universidad Francisco de Vitoria
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Francisco de Vitoria
  investigator full name: Miguel López Moreno
  investigator title: Principal Investigator
  mesh term: Metabolic Syndrome
  sharing ipd: No