Impact of Beta-glucan Supplementation During Calorie and Carbohydrate-restricted Diet on Body Weight and Body Fat Loss, Appetite, and Gastrointestinal Appetite Hormones.

NCT07299942 | Recruiting DMC

• 1 other identifier: 200230098
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether beta-glucan supplementation, when added to an energy and carbohydrate-restricted diet, facilitates body weight and body fat loss, and leads to less detrimental changes in subjective appetite and gastrointestinal appetite hormones. This will be a double-blind, randomised, controlled trial in which healthy females living with overweight and obesity will be randomly assigned to a beta-glucan or a cellulose (placebo) group (1:1 basis). The randomisation software will be used to generate a randomisation list. This list will be held by a person independent of the research team. During the 4-week intervention, participants will consume an energy and carbohydrate-restricted diet combined with 9 g/day of beta-glucan (beta-glucan group) or 9 g/day of cellulose (Placebo group). During the 4-week intervention, breakfasts and dinners will consist of energy-restricted meal replacements providing 200 kcal/ meal, while lunches will be low-carbohydrate meals providing 35% of habitual energy intake. Before and at the end of the intervention, participants will conduct an experimental trial, with pre- and post-intervention trials being identical. The experimental trials will take place in the metabolic room of the New Lister Building (NLB) of the Glasgow Royal Infirmary. During the experimental trials, body weight and body composition will be measured in the fasted state, and the collection of fasting and postprandial (for the duration of 240 minutes) blood samples will be conducted. For a meal, participants will consume the low-calorie breakfast, which will be a liquid meal replacement (Cambridge Weight Plan, Corby, UK), together with 3 g of beta-glucan. Subjective appetite scores will be measured in the fasted and postprandial states. To achieve total body water and thus body composition (fat mass and fat-free mass) measurements, saliva will be collected before and 3 and 3.5 hours after consumption of D2O (which will be consumed in the fasted state). For the duration of 24 hours before the experimental trial, participants will be asked to avoid coffee and alcohol. Participants will be required to record their food and drink intake for three days before the trial days of each experimental investigation.

Conditions

Overweight and Obese Women

Keywords

overweight, obesity, body weigh loss, beta-glucan, appetite

Outcome Measures

Primary Outcomes (3)

• Body weight

  Body weight will be assessed in the fasted state using bioelectrical impedance analysis (TANITA-TBF-310, Cranela, UK).

  At the beginning (baseline, week 0 ) and at the end of the 4-week intervention, (post, week 4).

• Total body water

  Saliva samples collected before and after 3 hours and 3.30 hours of drinking D2O water during experimental trials, which will be conducted before and after 4 week intervention, will be analysed for total body water using Fourier Transform spectroscopy (FTIR).

  At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

• Subjective appetite

  Assessment of fasting and postprandial (over a duration of 240 minutes) appetite via visual analogue scale (100mm) during the experimental trials, conducted before (week 0) and after 4 4-week intervention.

  At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

Secondary Outcomes (1)

• Gastrointestinal appetite hormones

  At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

Study Arms (2)

Beta-glucan (9g/day) supplementation

EXPERIMENTAL

Beta-glucan (9g/day) combined with consumption of low low-calorie and low-carbohydrate diet for four weeks.

Combination Product: Beta-glucan addition to a restricted calorie of meal replacements and carbohydrate diet.

Cellulose addition to low calorie and low carbohydrate diet.

PLACEBO COMPARATOR

Cellulose (9g/day) combined with consumption of low low-calorie and low-carbohydrate diet for four weeks.

Combination Product: Cellulose (Placebo) addition to a restricted calorie of meal replacements and carbohydrate diet.

Interventions

Cellulose (Placebo) addition to a restricted calorie of meal replacements and carbohydrate diet. COMBINATION_PRODUCT

Female participants will undergo a 4-week intervention, which will involve taking 9 g/day of cellulose while consuming low-calorie liquid meal replacements (Cambridge Weight Plan, Corby, UK) for breakfast and dinner, each providing 200kcal, and low-carbohydrate lunches.

Cellulose addition to low calorie and low carbohydrate diet.

Beta-glucan addition to a restricted calorie of meal replacements and carbohydrate diet. COMBINATION_PRODUCT

Female participants will undergo a 4-week intervention, which will involve taking 9g/day of beta-glucan supplement while consuming low-calorie liquid meal replacements (Cambridge Weight Plan, Corby, UK) for breakfast and dinner, each providing 200kcal, and low-carbohydrate lunches.

Beta-glucan (9g/day) supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female by birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females living with overweight or obese (BMI of 25 - 39.9 kg/m2).
• Age between 18 to 60 years.
• Stable body weight for at least 3 months preceding the study.

You may not qualify if:

• Smokers
• Irregular menstrual cycle
• Exercising more than 75min a week
• Pregnant or lactating
• Food allergies
• Vegan or vegetarian or follow any diet other than the typical Western diet.
• Taking dietary supplement at the time of the study.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Human Nutrition, College of Medicine, Veterinary and Life Science,

Glasgow, G31 2ER, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Dalia Malkova

CONTACT

01412018690; Dalia.Malkova@glasgow.ac.uk

Nesreen Baobid

CONTACT

0913839B@student.gla.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: December 23, 2025
• Study Start: July 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: December 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)