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/NCT06022315</url>
    </required_header>
    <id_info>
      <org_study_id>University of Glasgow</org_study_id>
      <nct_id>NCT06022315</nct_id>
    </id_info>
    <brief_title>Impact of Macronutrient Composition of Energy-restricted Diet and Exercise on Body Composition and Appetite Hormones.</brief_title>
    <official_title>Role of Gastrointestinal Appetite Hormones in the Success of Body Mass Loss Interventions Based on Exercise Combined With Calorie-restricted Diets With Different Fat and Carbohydrate Content</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Glasgow</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>
        The main aim of this study is to investigate the effect of energy-restricted low and&#xD;
        high-carbohydrate diet combined with exercise training on appetite regulatory hormones,&#xD;
        subjective appetite and energy intake in overweight and obese women. In addition, since the&#xD;
        macronutrient composition of meals and exercise impacts biomarkers of cardiovascular disease,&#xD;
        the impact of these interactions on metabolic risk factors of cardiovascular diseases will&#xD;
        also be investigated .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a block randomised parallel study, with one group of participants undergoing&#xD;
        exercise training combined with the consumption of a calorie-restricted high CHO-low FAT diet&#xD;
        and another group undergoing exercise training with consumption of a calorie-restricted low&#xD;
        CHO-high FAT diet. The interventions will last for 4 weeks. Prior to and after the&#xD;
        interventions participants will undergo a 5-hour experimental trial, which will involve body&#xD;
        composition measurements by the D2O method, appetite hormones, insulin via blood collection&#xD;
        and subjective appetite via a visual analogue scale. During the experimental trials,&#xD;
        participants will consume breakfast and ad libitum buffet-style lunch.&#xD;
  &#xD;
        Prior to the first experimental trial, participants will be subjected to a screening process&#xD;
        followed by a preliminary exercise test in the metabolic research unit at New Lister Building&#xD;
        (NLB), Glasgow Royal infirmary (GRI). Participants will also be asked to record their food&#xD;
        and drink consumed for 4 days (3 weekdays and 1 weekend) prior to and during the four last&#xD;
        days of the intervention. By following this step, individual diets will be designed based on&#xD;
        participants preferences with restricted energy intake and different macronutrient&#xD;
        compositions. Dietary intake records will allow a comparison of participants' calorie intake&#xD;
        before and after the intervention.&#xD;
  &#xD;
        During intervention participants will consume either energy-restricted low CHO-high FAT or&#xD;
        energy-restricted high CHO-Low FAT diet and exercise (brisk walking) while wearing a heart&#xD;
        rate monitor 3 times a week after 5 minutes of warm-up, and 5 minutes The duration of the&#xD;
        brisk walking will increase after week one from 30 to 45 minutes and to 60 minutes at week&#xD;
        three and four. Participants will be advised to cool down after the brisk walking session.&#xD;
        During the intervention, participants will be encouraged to avoid alcohol consumption. In&#xD;
        case this was not possible, a maximum amount of two units will be allowed per week.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gastrointestinal appetite hormones</measure>
      <time_frame>240 minutes through study completion</time_frame>
      <description>Plasma concentration (pg/ml) before and after intervention during experimental trials</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total body water</measure>
      <time_frame>at baseline and after 3 hours</time_frame>
      <description>Saliva sample (ml) before and after 3 hours of drinking D2O water during experimental trials</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>subjective appetite</measure>
      <time_frame>240 minutes through study completion</time_frame>
      <description>Assess via visual analogue scale (100mm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>energy intake</measure>
      <time_frame>3 days before and after intervention</time_frame>
      <description>Energy intake (Kcal) during intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin</measure>
      <time_frame>240 minutes through study completion</time_frame>
      <description>Plasma concentration (mU/L)before and after intervention during experimental trials</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Gastrointestinal Hormones</condition>
    <arm_group>
      <arm_group_label>restricted high carbohydrate low fat diet with exercise training program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>exercise training combined with the consumption of caloric restricted high CHO-low FAT diet. The interventions will last for four weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>restricted High fat low carbohydrate diet with exercise training program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>exercise training with consumption of caloric restricted low CHO-high FAT diet. The interventions will last for four weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>caloric restrction high carbohydrate low fat diet with exercise training program</intervention_name>
      <description>Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold. The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.&#xD;
  Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the high CHO-low FAT diet, carbohydrates, fat, and protein will provide 60%, 25%, and 15% of individually predicted daily energy intake, respectively. Variety (n=7) of daily menus for calorie-restricted high FAT-low CHO diet will be provided and menus for high CHO-low FAT diet on pasta, rice, oats, fruit, and vegetable.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.</description>
      <arm_group_label>restricted high carbohydrate low fat diet with exercise training program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>caloric restrction high fat low carbohydrate diet with exercise training program</intervention_name>
      <description>Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold.The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.&#xD;
  Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the low CHO-high FAT diet, the proportion of energy provided by CHO, fat, and protein will consist of 25%, 60%, and 15%, respectively. Variety (n=7) of daily menus for calorie-restricted low CHO-high FAT diet will be provided and menus for high FAT-low CHO group will be based on meat, fish, cheese, butter, and nuts.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.</description>
      <arm_group_label>restricted High fat low carbohydrate diet with exercise training program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy Female&#xD;
  &#xD;
            -  BMI of ≥25.0 kg/m2.&#xD;
  &#xD;
            -  stable body weight for at least three months preceding the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  smokers and have&#xD;
  &#xD;
            -  irregular menstruation cycle,&#xD;
  &#xD;
            -  use any type of medication,&#xD;
  &#xD;
            -  exercising more than 75min a week,&#xD;
  &#xD;
            -  are pregnant or lactating.&#xD;
  &#xD;
            -  on any dietary supplements at the time of the study,&#xD;
  &#xD;
            -  are vegetarian or are following any diet other than the typical Western diet.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Taibah Almesbehi</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dr Dalia Malkova</last_name>
      <phone>01412018690</phone>
      <email>Dalia.Malkova@glasgow.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Taibah Almesbehi</last_name>
      <phone>07454900691</phone>
      <email>t.almesbehi.1@research.gla.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Human Nutrition, College of Medicine, Veterinary and Life Science</name>
        <address>
          <city>Glasgow</city>
          <zip>G31 2ER</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Dalia Malkova, PhD</last_name>
        <phone>+442523018690</phone>
        <email>Dalia.Malkova@glasgow.ac.ul</email>
      </contact>
      <contact_backup>
        <last_name>Taibah Almesbehi, Msc</last_name>
        <phone>+441412018694</phone>
        <email>t.almesbehi.1@research.glasgow.ac.uk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Glasgow</investigator_affiliation>
      <investigator_full_name>Dr Dalia Malkova</investigator_full_name>
      <investigator_title>Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary &amp; Life Sciences University of Glasgow</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The study will published in scientific journal upon finished</ipd_description>
    </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/NCT06022315
  org study id: University of Glasgow
  nct id: NCT06022315
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main aim of this study is to investigate the effect of energy-restricted low and
        high-carbohydrate diet combined with exercise training on appetite regulatory hormones,
        subjective appetite and energy intake in overweight and obese women. In addition, since the
        macronutrient composition of meals and exercise impacts biomarkers of cardiovascular disease,
        the impact of these interactions on metabolic risk factors of cardiovascular diseases will
        also be investigated .
  This will be a block randomised parallel study, with one group of participants undergoing
        exercise training combined with the consumption of a calorie-restricted high CHO-low FAT diet
        and another group undergoing exercise training with consumption of a calorie-restricted low
        CHO-high FAT diet. The interventions will last for 4 weeks. Prior to and after the
        interventions participants will undergo a 5-hour experimental trial, which will involve body
        composition measurements by the D2O method, appetite hormones, insulin via blood collection
        and subjective appetite via a visual analogue scale. During the experimental trials,
        participants will consume breakfast and ad libitum buffet-style lunch.
  
        Prior to the first experimental trial, participants will be subjected to a screening process
        followed by a preliminary exercise test in the metabolic research unit at New Lister Building
        (NLB), Glasgow Royal infirmary (GRI). Participants will also be asked to record their food
        and drink consumed for 4 days (3 weekdays and 1 weekend) prior to and during the four last
        days of the intervention. By following this step, individual diets will be designed based on
        participants preferences with restricted energy intake and different macronutrient
        compositions. Dietary intake records will allow a comparison of participants' calorie intake
        before and after the intervention.
  
        During intervention participants will consume either energy-restricted low CHO-high FAT or
        energy-restricted high CHO-Low FAT diet and exercise (brisk walking) while wearing a heart
        rate monitor 3 times a week after 5 minutes of warm-up, and 5 minutes The duration of the
        brisk walking will increase after week one from 30 to 45 minutes and to 60 minutes at week
        three and four. Participants will be advised to cool down after the brisk walking session.
        During the intervention, participants will be encouraged to avoid alcohol consumption. In
        case this was not possible, a maximum amount of two units will be allowed per week.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Gastrointestinal appetite hormones
  time frame: 240 minutes through study completion
  description: Plasma concentration (pg/ml) before and after intervention during experimental trials
  measure: Total body water
  time frame: at baseline and after 3 hours
  description: Saliva sample (ml) before and after 3 hours of drinking D2O water during experimental trials
  measure: subjective appetite
  time frame: 240 minutes through study completion
  description: Assess via visual analogue scale (100mm)
  measure: energy intake
  time frame: 3 days before and after intervention
  description: Energy intake (Kcal) during intervention
  measure: Insulin
  time frame: 240 minutes through study completion
  description: Plasma concentration (mU/L)before and after intervention during experimental trials
  arm group label: restricted high carbohydrate low fat diet with exercise training program
  arm group type: Experimental
  description: exercise training combined with the consumption of caloric restricted high CHO-low FAT diet. The interventions will last for four weeks.
  arm group label: restricted High fat low carbohydrate diet with exercise training program
  arm group type: Experimental
  description: exercise training with consumption of caloric restricted low CHO-high FAT diet. The interventions will last for four weeks.
  intervention type: Combination Product
  intervention name: caloric restrction high carbohydrate low fat diet with exercise training program
  description: Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold. The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.
  Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the high CHO-low FAT diet, carbohydrates, fat, and protein will provide 60%, 25%, and 15% of individually predicted daily energy intake, respectively. Variety (n=7) of daily menus for calorie-restricted high FAT-low CHO diet will be provided and menus for high CHO-low FAT diet on pasta, rice, oats, fruit, and vegetable.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.
  arm group label: restricted high carbohydrate low fat diet with exercise training program
  intervention type: Combination Product
  intervention name: caloric restrction high fat low carbohydrate diet with exercise training program
  description: Subjects will perform 3 sessions/week of brisk walking for four weeks at a heart rate corresponding to 85-90% of the lactate threshold.The duration of exercise sessions will increase from 30 minutes to 45 minutes in week 2 and from 45 minutes to 60 minutes in weeks 3 and 4.
  Experimental diets will be calorie-restricted and provide 70% of estimated daily energy requirements. In the low CHO-high FAT diet, the proportion of energy provided by CHO, fat, and protein will consist of 25%, 60%, and 15%, respectively. Variety (n=7) of daily menus for calorie-restricted low CHO-high FAT diet will be provided and menus for high FAT-low CHO group will be based on meat, fish, cheese, butter, and nuts.During the intervention, participants will be encouraged to avoid alcohol consumption and only the maximum amount of two units will be allowed per week.
  arm group label: restricted High fat low carbohydrate diet with exercise training program
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Taibah Almesbehi
  role: Principal Investigator
  affiliation: University of Glasgow, New lister Building, Glasgow, Scotland, United kingdom, G31 2ER
  last name: Dr Dalia Malkova
  phone: 01412018690
  email: Dalia.Malkova@glasgow.ac.uk
  last name: Taibah Almesbehi
  phone: 07454900691
  email: t.almesbehi.1@research.gla.ac.uk
  facility: 
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Glasgow
  investigator full name: Dr Dalia Malkova
  investigator title: Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow
  sharing ipd: No
  ipd description: The study will published in scientific journal upon finished