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/NCT05981404</url>
    </required_header>
    <id_info>
      <org_study_id>200210051</org_study_id>
      <nct_id>NCT05981404</nct_id>
    </id_info>
    <brief_title>Impact of ß-glucan Supplementation on Subjective Appetite and Gastrointestinal Appetite Hormones.</brief_title>
    <official_title>Impact of ß-glucan Supplementation During Calorie and Carbohydrate Restriction on Subjective Appetite and Gastrointestinal Appetite Hormones in Overweight Adults.</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>Yes</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 goal of this clinical trial is to how supplementation with beta -glucan during two days&#xD;
        of caloric and carbohydrate restriction impacts subjective appetite and gastrointestinal&#xD;
        appetite hormones in healthy overweight adults. In addition, the study aims to investigate&#xD;
        the impact on gastric emptying since appetite and energy intake following food or supplement&#xD;
        consumption can also relate to their impact on gastric emptying and as reduced hunger and&#xD;
        enhanced satiety have been reported to be linked with delayed gastric emptying. The study&#xD;
        will also investigate how these interactions impact after meal responses of insulin and&#xD;
        glucose and thus insulin sensitivity. The caloric restriction during breakfasts and dinners&#xD;
        will be achieved by low-calorie ready meals in the format of the counterweight PRO800 diet&#xD;
        and lunches will be low in carbohydrates. It aims to test whether the addition of β-glucan to&#xD;
        calorie and carbohydrate-restricted meals amends postprandial responses of appetite hormones&#xD;
        and subjective appetite.&#xD;
  &#xD;
        participated will be assigned in double-blinded randomised crossover study, intervention&#xD;
        group will be supplemented with 3g beta-glucan and the control group supplemented with 3g&#xD;
        placebo.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a randomised crossover study which will be conducted on overweight and obese&#xD;
        women with BMI of 27-35 kg/m2 and 18 -50 years old. Subjects will conduct two experimental&#xD;
        trials, each lasting over 2 days and involving the consumption of two low-calorie meal&#xD;
        replacements, one for breakfast and another one for dinner, and a low carbohydrate lunch meal&#xD;
        for 2 consecutive days. In one trial, during each meal participants will take 3g of&#xD;
        beta-glucan supplement and 3 g of cellulose as a placebo will be taken in another trial. On&#xD;
        day 1 of each trial, a low-calorie breakfast will be consumed at the metabolic investigation&#xD;
        laboratory at New Lister Building (NLB) of Glasgow Royal Infirmary and low carbohydrate lunch&#xD;
        and low-calorie dinner at home. On day 2, breakfast and lunch will be consumed at the&#xD;
        laboratory. On day 2, prior to the breakfast, 1000mg of paracetamol will be taken, and blood&#xD;
        samples, breath hydrogen tests, appetite questionnaires and metabolic rate measurements will&#xD;
        be obtained for 7 hours after the completion of breakfast. Trials will be separated by a&#xD;
        7-day washout period. All measurements will be collected at New Lister Building (NLB). Prior&#xD;
        to the main experimental trials, participants will be asked to undergo a screening session&#xD;
        which includes answering a health screening questionnaire and undergoing measurements of&#xD;
        height, body weight, body composition and resting energy expenditure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 26, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Experimental trial beta-glucan or experimental trial control (placebo)</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in gastrointestinal appetite hormones and appetite scores between the two groups.</measure>
      <time_frame>On day 2 of each experimental trial.</time_frame>
      <description>Taking blood samples every 30 minutes to test the changes in appetite hormones. Asking participants to answer questionnaires which will be calculated by Validated Visual Analogue Scale (VAS). The scale is 100 mm in length with words anchored to a minimum and a maximum of the ''desire to eat'', ''fullness'', ''hunger'' and ''satiety'' the point corresponding to their sensations.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Overweight and Obesity</condition>
    <arm_group>
      <arm_group_label>Low calorie and low carbohydrate meals with β-glucan.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>On day 1, a low-calorie breakfast will be consumed at the metabolic investigation laboratory at New Lister Building (NLB) of Glasgow Royal Infirmary but low carbohydrate lunch and low-calorie dinner at home. On day 2, breakfast and lunch will be consumed at the laboratory and, prior to the breakfast, 1000mg of paracetamol will be taken, blood samples, breath hydrogen tests, appetite questionnaires will be obtained for 7 hours after the completion of breakfast. 3g β-glucan will be consumed with each meal on both days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low calorie and low carbohydrate meals with placebo.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>On day 1, a low-calorie breakfast will be consumed at the metabolic investigation laboratory at New Lister Building (NLB) of Glasgow Royal Infirmary but low carbohydrate lunch and low-calorie dinner at home. On day 2, breakfast and lunch will be consumed at the laboratory and, prior to the breakfast, 1000mg of paracetamol will be taken, blood samples, breath hydrogen tests, appetite questionnaires will be obtained for 7 hours after the completion of breakfast. 3g cellulose will be consumed with each meal on both days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>β-glucan</intervention_name>
      <description>Consuming 3g β-glucan with each meal.</description>
      <arm_group_label>Low calorie and low carbohydrate meals with β-glucan.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Consuming 3g Cellulose with each meal.</description>
      <arm_group_label>Low calorie and low carbohydrate meals with placebo.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Participants will be asked to confirm whether they had stable body weight for at least 3&#xD;
          months and are not following a diet to gain or lose weight. They will also be asked to&#xD;
          confirm that they are non-smokers, not on long-term medication, not pregnant or lactating,&#xD;
          and have no known food allergies to the ingredients in test meals and to Paracetamol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants will be excluded if they are smokers and have irregular menstruation cycles,&#xD;
          use any type of medication, exercised more than 75min a week, were pregnant or lactating.&#xD;
          Participants will be required to be free of any medical condition, including having food&#xD;
          allergies and stable body weight for at least 3 months preceding the study. Participants&#xD;
          will be excluded if they are allergic to paracetamol and any types of food and were&#xD;
          following any weight loss diet for the last 3 months, are vegan or vegetarian or follow any&#xD;
          diet other than the typical Western diet. Participants will be expected to be not on any&#xD;
          kind of dietary supplement at the time of the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dalia Malkova, PhD</last_name>
      <phone>07753433971</phone>
      <email>dalia.malkova@glasgow.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Glasgow</name>
        <address>
          <city>Glasgow</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dalia Malkova</last_name>
        <email>dalia.malkova@glasgow.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <reference>
      <citation>Fechner E, Smeets ETHC, Schrauwen P, Mensink RP. The Effects of Different Degrees of Carbohydrate Restriction and Carbohydrate Replacement on Cardiometabolic Risk Markers in Humans-A Systematic Review and Meta-Analysis. Nutrients. 2020 Apr 2;12(4):991. doi: 10.3390/nu12040991.</citation>
      <PMID>32252374</PMID>
    </reference>
    <results_reference>
      <citation>Wang GJ, Tomasi D, Backus W, Wang R, Telang F, Geliebter A, Korner J, Bauman A, Fowler JS, Thanos PK, Volkow ND. Gastric distention activates satiety circuitry in the human brain. Neuroimage. 2008 Feb 15;39(4):1824-31. doi: 10.1016/j.neuroimage.2007.11.008. Epub 2007 Nov 22.</citation>
      <PMID>18155924</PMID>
    </results_reference>
    <results_reference>
      <citation>Thom G, Dombrowski SU, Brosnahan N, Algindan YY, Rosario Lopez-Gonzalez M, Roditi G, Lean MEJ, Malkova D. The role of appetite-related hormones, adaptive thermogenesis, perceived hunger and stress in long-term weight-loss maintenance: a mixed-methods study. Eur J Clin Nutr. 2020 Apr;74(4):622-632. doi: 10.1038/s41430-020-0568-9. Epub 2020 Feb 4. Erratum In: Eur J Clin Nutr. 2021 Jun;75(6):997-998.</citation>
      <PMID>32020057</PMID>
    </results_reference>
    <results_reference>
      <citation>Miyamoto J, Watanabe K, Taira S, Kasubuchi M, Li X, Irie J, Itoh H, Kimura I. Barley beta-glucan improves metabolic condition via short-chain fatty acids produced by gut microbial fermentation in high fat diet fed mice. PLoS One. 2018 Apr 26;13(4):e0196579. doi: 10.1371/journal.pone.0196579. eCollection 2018.</citation>
      <PMID>29698465</PMID>
    </results_reference>
    <results_reference>
      <citation>Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS. Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/bmj.k4583. Erratum In: BMJ. 2020 Nov 3;371:m4264.</citation>
      <PMID>30429127</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 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>Coordinator of L4 Nutrition Programmes, Senior Lecturer.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</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/NCT05981404
  org study id: 200210051
  nct id: NCT05981404
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to how supplementation with beta -glucan during two days
        of caloric and carbohydrate restriction impacts subjective appetite and gastrointestinal
        appetite hormones in healthy overweight adults. In addition, the study aims to investigate
        the impact on gastric emptying since appetite and energy intake following food or supplement
        consumption can also relate to their impact on gastric emptying and as reduced hunger and
        enhanced satiety have been reported to be linked with delayed gastric emptying. The study
        will also investigate how these interactions impact after meal responses of insulin and
        glucose and thus insulin sensitivity. The caloric restriction during breakfasts and dinners
        will be achieved by low-calorie ready meals in the format of the counterweight PRO800 diet
        and lunches will be low in carbohydrates. It aims to test whether the addition of β-glucan to
        calorie and carbohydrate-restricted meals amends postprandial responses of appetite hormones
        and subjective appetite.
  
        participated will be assigned in double-blinded randomised crossover study, intervention
        group will be supplemented with 3g beta-glucan and the control group supplemented with 3g
        placebo.
  This will be a randomised crossover study which will be conducted on overweight and obese
        women with BMI of 27-35 kg/m2 and 18 -50 years old. Subjects will conduct two experimental
        trials, each lasting over 2 days and involving the consumption of two low-calorie meal
        replacements, one for breakfast and another one for dinner, and a low carbohydrate lunch meal
        for 2 consecutive days. In one trial, during each meal participants will take 3g of
        beta-glucan supplement and 3 g of cellulose as a placebo will be taken in another trial. On
        day 1 of each trial, a low-calorie breakfast will be consumed at the metabolic investigation
        laboratory at New Lister Building (NLB) of Glasgow Royal Infirmary and low carbohydrate lunch
        and low-calorie dinner at home. On day 2, breakfast and lunch will be consumed at the
        laboratory. On day 2, prior to the breakfast, 1000mg of paracetamol will be taken, and blood
        samples, breath hydrogen tests, appetite questionnaires and metabolic rate measurements will
        be obtained for 7 hours after the completion of breakfast. Trials will be separated by a
        7-day washout period. All measurements will be collected at New Lister Building (NLB). Prior
        to the main experimental trials, participants will be asked to undergo a screening session
        which includes answering a health screening questionnaire and undergoing measurements of
        height, body weight, body composition and resting energy expenditure.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Experimental trial beta-glucan or experimental trial control (placebo)
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Changes in gastrointestinal appetite hormones and appetite scores between the two groups.
  time frame: On day 2 of each experimental trial.
  description: Taking blood samples every 30 minutes to test the changes in appetite hormones. Asking participants to answer questionnaires which will be calculated by Validated Visual Analogue Scale (VAS). The scale is 100 mm in length with words anchored to a minimum and a maximum of the ''desire to eat'', ''fullness'', ''hunger'' and ''satiety'' the point corresponding to their sensations.
  arm group label: Low calorie and low carbohydrate meals with β-glucan.
  arm group type: Experimental
  description: On day 1, a low-calorie breakfast will be consumed at the metabolic investigation laboratory at New Lister Building (NLB) of Glasgow Royal Infirmary but low carbohydrate lunch and low-calorie dinner at home. On day 2, breakfast and lunch will be consumed at the laboratory and, prior to the breakfast, 1000mg of paracetamol will be taken, blood samples, breath hydrogen tests, appetite questionnaires will be obtained for 7 hours after the completion of breakfast. 3g β-glucan will be consumed with each meal on both days.
  arm group label: Low calorie and low carbohydrate meals with placebo.
  arm group type: Experimental
  description: On day 1, a low-calorie breakfast will be consumed at the metabolic investigation laboratory at New Lister Building (NLB) of Glasgow Royal Infirmary but low carbohydrate lunch and low-calorie dinner at home. On day 2, breakfast and lunch will be consumed at the laboratory and, prior to the breakfast, 1000mg of paracetamol will be taken, blood samples, breath hydrogen tests, appetite questionnaires will be obtained for 7 hours after the completion of breakfast. 3g cellulose will be consumed with each meal on both days.
  intervention type: Dietary Supplement
  intervention name: β-glucan
  description: Consuming 3g β-glucan with each meal.
  arm group label: Low calorie and low carbohydrate meals with β-glucan.
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Consuming 3g Cellulose with each meal.
  arm group label: Low calorie and low carbohydrate meals with placebo.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dalia Malkova, PhD
  phone: 07753433971
  email: dalia.malkova@glasgow.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  citation: Fechner E, Smeets ETHC, Schrauwen P, Mensink RP. The Effects of Different Degrees of Carbohydrate Restriction and Carbohydrate Replacement on Cardiometabolic Risk Markers in Humans-A Systematic Review and Meta-Analysis. Nutrients. 2020 Apr 2;12(4):991. doi: 10.3390/nu12040991.
  PMID: 32252374
  citation: Wang GJ, Tomasi D, Backus W, Wang R, Telang F, Geliebter A, Korner J, Bauman A, Fowler JS, Thanos PK, Volkow ND. Gastric distention activates satiety circuitry in the human brain. Neuroimage. 2008 Feb 15;39(4):1824-31. doi: 10.1016/j.neuroimage.2007.11.008. Epub 2007 Nov 22.
  PMID: 18155924
  citation: Thom G, Dombrowski SU, Brosnahan N, Algindan YY, Rosario Lopez-Gonzalez M, Roditi G, Lean MEJ, Malkova D. The role of appetite-related hormones, adaptive thermogenesis, perceived hunger and stress in long-term weight-loss maintenance: a mixed-methods study. Eur J Clin Nutr. 2020 Apr;74(4):622-632. doi: 10.1038/s41430-020-0568-9. Epub 2020 Feb 4. Erratum In: Eur J Clin Nutr. 2021 Jun;75(6):997-998.
  PMID: 32020057
  citation: Miyamoto J, Watanabe K, Taira S, Kasubuchi M, Li X, Irie J, Itoh H, Kimura I. Barley beta-glucan improves metabolic condition via short-chain fatty acids produced by gut microbial fermentation in high fat diet fed mice. PLoS One. 2018 Apr 26;13(4):e0196579. doi: 10.1371/journal.pone.0196579. eCollection 2018.
  PMID: 29698465
  citation: Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS. Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/bmj.k4583. Erratum In: BMJ. 2020 Nov 3;371:m4264.
  PMID: 30429127
  responsible party type: Principal Investigator
  investigator affiliation: University of Glasgow
  investigator full name: Dr Dalia Malkova
  investigator title: Coordinator of L4 Nutrition Programmes, Senior Lecturer.
  mesh term: Overweight
  sharing ipd: No