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Impact of ß-glucan Supplementation on Subjective Appetite and Gastrointestinal Appetite Hormones.

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
β-glucan
Placebo
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants will be asked to confirm whether they had stable body weight for at least 3 months and are not following a diet to gain or lose weight. They will also be asked to confirm that they are non-smokers, not on long-term medication, not pregnant or lactating, and have no known food allergies to the ingredients in test meals and to Paracetamol. Exclusion Criteria: Participants will be excluded if they are smokers and have irregular menstruation cycles, use any type of medication, exercised more than 75min a week, were pregnant or lactating. Participants will be required to be free of any medical condition, including having food allergies and stable body weight for at least 3 months preceding the study. Participants will be excluded if they are allergic to paracetamol and any types of food and were following any weight loss diet for the last 3 months, are vegan or vegetarian or follow any diet other than the typical Western diet. Participants will be expected to be not on any kind of dietary supplement at the time of the study.

Sites / Locations

  • University of GlasgowRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low calorie and low carbohydrate meals with β-glucan.

Low calorie and low carbohydrate meals with placebo.

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes in gastrointestinal appetite hormones and appetite scores between the two groups.
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.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT05981404
Brief Title
Impact of ß-glucan Supplementation on Subjective Appetite and Gastrointestinal Appetite Hormones.
Official Title
Impact of ß-glucan Supplementation During Calorie and Carbohydrate Restriction on Subjective Appetite and Gastrointestinal Appetite Hormones in Overweight Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Experimental trial beta-glucan or experimental trial control (placebo)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low calorie and low carbohydrate meals with β-glucan.
Arm Type
Experimental
Arm 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 Title
Low calorie and low carbohydrate meals with placebo.
Arm Type
Experimental
Arm 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(s)
β-glucan
Intervention Description
Consuming 3g β-glucan with each meal.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Consuming 3g Cellulose with each meal.
Primary Outcome Measure Information:
Title
Changes in gastrointestinal appetite hormones and appetite scores between the two groups.
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.
Time Frame
On day 2 of each experimental trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants will be asked to confirm whether they had stable body weight for at least 3 months and are not following a diet to gain or lose weight. They will also be asked to confirm that they are non-smokers, not on long-term medication, not pregnant or lactating, and have no known food allergies to the ingredients in test meals and to Paracetamol. Exclusion Criteria: Participants will be excluded if they are smokers and have irregular menstruation cycles, use any type of medication, exercised more than 75min a week, were pregnant or lactating. Participants will be required to be free of any medical condition, including having food allergies and stable body weight for at least 3 months preceding the study. Participants will be excluded if they are allergic to paracetamol and any types of food and were following any weight loss diet for the last 3 months, are vegan or vegetarian or follow any diet other than the typical Western diet. Participants will be expected to be not on any kind of dietary supplement at the time of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia Malkova, PhD
Phone
07753433971
Email
dalia.malkova@glasgow.ac.uk
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia Malkova
Email
dalia.malkova@glasgow.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32252374
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.
Results Reference
background
PubMed Identifier
18155924
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.
Results Reference
result
PubMed Identifier
32020057
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.
Results Reference
result
PubMed Identifier
29698465
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.
Results Reference
result
PubMed Identifier
30429127
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.
Results Reference
result

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Impact of ß-glucan Supplementation on Subjective Appetite and Gastrointestinal Appetite Hormones.

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