RecruitingNAINTERVENTIONAL

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

This research wants to find out if taking a supplement called beta-glucan, alongside a diet that limits calories and carbohydrates, helps overweight or obese women lose weight and body fat more effectively. We also want to see if it helps reduce common hunger pangs and changes in appetite hormones that can happen with dieting. Sixty healthy women, aged 18-60, with a BMI between 25 and 39.9, will take part. They will be randomly assigned to one of two groups: one receiving beta-glucan and the other a dummy pill (cellulose). For four weeks, all participants will follow a specific diet involving meal replacements for breakfast and dinner, and a low-carb lunch. We'll measure weight, body fat, and blood samples to check appetite hormones before and after the study. This is a "double-blind" study, meaning neither the participants nor the researchers will know who is getting the beta-glucan and who is getting the dummy pill, ensuring fair and unbiased results.

At a glance

Status

Recruiting

Phase

Sponsor

University of Glasgow

Enrolment target

Start

01 Jul 2024

Estimated completion

30 Dec 2025

Overweight and Obese Women

What is this study about?

Imagine you're trying to lose weight, and you're following a special diet. This study wants to see if adding a natural fiber, called beta-glucan, to that diet can make it easier and more successful. Beta-glucan is found in things like oats and barley, and it's thought to help you feel fuller for longer. We're also curious if this supplement can help by balancing your hunger hormones, which are chemicals in your body that tell you when you're hungry or full. Sometimes, when people diet, these hormones can get out of whack, making it harder to stick to the plan.

We'll be focusing on women who are overweight or obese, as they are often looking for effective and sustainable ways to manage their weight. The study will last for four weeks, during which all participants will follow a carefully planned diet. This diet will include special meal replacements for breakfast and dinner and a low-carbohydrate lunch. The main difference between the groups is that half the women will receive the beta-glucan supplement, and the other half will get a dummy pill (called a placebo, which looks identical but has no active ingredients). This helps us figure out if any changes are truly due to the beta-glucan itself.

Throughout the study, we'll be carefully monitoring various things like your weight, how much body fat you lose, and how your feelings of hunger change. We'll also take blood samples to measure those important hunger hormones. By comparing the results from the beta-glucan group with the dummy pill group, we hope to learn if beta-glucan can be a helpful addition to a weight-loss plan for women.

Key takeaways

Tests if beta-glucan fiber helps with weight loss and hunger.
For overweight or obese women aged 18-60.
Involves a 4-week calorie and carb-restricted diet.
Participants take either beta-glucan or a dummy pill.
Study measures weight, body fat, and hunger hormones.
Neither you nor researchers know who gets what (double-blind).

Who may be eligible?

This study is looking for women who are between 18 and 60 years old and are considered overweight or obese. This means your Body Mass Index (BMI) should be between 25 and 39.9. You should also have had a stable weight for at least three months before the study starts, meaning you haven't recently gained or lost a lot of weight.

There are some reasons why you wouldn't be able to join the study. If you smoke, are pregnant or breastfeeding, or have certain allergies to food, this study isn't for you. It's also not suitable if you exercise a lot (more than 75 minutes a week), have an irregular monthly period, or follow a vegan or vegetarian diet, or any diet other than a typical Western diet. If you're currently taking any other dietary supplements, you also wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 18 and 60?
Is your BMI (Body Mass Index) between 25 and 39.9?
Has your weight been stable for the last 3 months?
Do you exercise less than 75 minutes per week?
Are you a non-smoker, not pregnant or breastfeeding?
Do you NOT follow a vegan, vegetarian, or restrictive non-Western diet?

Answer every question to see your result.

What does participation involve?

If you join this study, the total commitment will be for around five weeks. Before the main 4-week study, you'll have a screening visit to check if you're suitable. This will involve filling out a health questionnaire, having your height and weight measured, and some other checks.

During the 4-week study, you will follow a specific diet plan. This includes special meal replacements for breakfast and dinner, and a low-carbohydrate lunch. You'll also take either the beta-glucan supplement or a dummy pill every day. You'll be asked to keep a record of everything you eat and drink for three days before certain visits.

Before you start the 4-week diet and again at the end, you will have a longer visit (around half a day) to a special metabolic lab in Glasgow. On these days, you'll need to arrive after not eating overnight. We'll measure your weight and body make-up, and you'll have a small tube placed in your arm to collect blood samples multiple times throughout the morning. You'll also be asked to drink some special water (D2O) and we'll collect saliva samples a few times to help measure your body fat. On these days, you'll be given a low-calorie breakfast. Before these longer visits, you'll need to avoid coffee and alcohol for 24 hours.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You might experience weight and body fat loss, and the special diet combined with the supplement could help manage your hunger levels. You'll also receive careful monitoring of your health during the study. However, like any study, there are some potential discomforts or minor risks, such as having blood samples taken or following a restricted diet. You might also experience mild digestive changes due to the fiber. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Human Nutrition, College of Medicine, Veterinary and Life Science,
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What is beta-glucan?

Beta-glucan is a type of natural fiber found in foods like oats and barley. It's thought to help you feel full and manage blood sugar.

What is a 'dummy pill'?

A dummy pill, or placebo, looks exactly like the real supplement but doesn't contain any active ingredients. It helps us see if the beta-glucan truly makes a difference.

Will I know if I'm getting the beta-glucan or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the research team will know who is getting what until after the study is finished. This makes the results more reliable.

What kind of diet will I follow?

You'll follow a diet with meal replacements for breakfast and dinner, and a low-carbohydrate lunch for four weeks.

Where does the study take place?

The main visits and tests will happen at the metabolic room of the New Lister Building (NLB) of the Glasgow Royal Infirmary.

How to find out more

Dalia Malkova

Dalia.Malkova@glasgow.ac.uk 01412018690 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.