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RecruitingNAINTERVENTIONAL

Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing

This study aims to understand how eating different amounts of food affects certain 'hunger' and 'fullness' hormones in our gut. We're looking at two specific hormones, LEAP2 and ghrelin, and how their levels change in the blood after people drink liquid meals of various sizes. Participants include healthy adults with and without obesity. We want to discover if larger meals cause bigger changes in these hormones, and if these changes are linked to how hungry or full someone feels, and how much they choose to eat at a later meal. We also want to see if there are differences in these responses between people with and without obesity. Understanding this could help us learn more about appetite and body weight.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Imperial College London
Enrolment target
30
Start
29 Aug 2023
Estimated completion
01 Aug 2025

What is this study about?

You've probably noticed that what and how much you eat can affect how hungry or full you feel. This study is all about understanding the hidden chemical messages in your body, called hormones, that play a big role in controlling your appetite. We're particularly interested in two gut hormones: ghrelin, which generally makes you feel hungry, and LEAP2, which helps reduce hunger by working against ghrelin.

Scientists already know that after you eat, ghrelin levels tend to go down, and LEAP2 levels go up. This study wants to find out if eating a larger meal causes a bigger change in these hormone levels. We also want to see if these hormone changes are connected to how full you feel after a meal and how much you might eat next. For example, if a big meal causes a big jump in LEAP2 and a drop in ghrelin, does that mean you'll feel fuller for longer and eat less at your next meal?

Another important part of this study is comparing these responses between healthy adults. We'll be looking both at people who do not have obesity and those who do. We know that the levels of these hormones can be different in people with and without obesity, so it's key to see if their bodies react differently to meals. By exploring these questions, we hope to gain a better understanding of how our bodies regulate appetite and food intake, which could lead to new insights into managing weight and health.

Key takeaways

  • The study explores how different meal sizes affect hunger and fullness hormones.
  • It investigates two specific hormones: LEAP2 (reduces hunger) and ghrelin (increases hunger).
  • Both healthy adults with and without obesity are included.
  • Participation involves four visits, drinking different liquid meals, blood tests, and appetite ratings.
  • Results could help us better understand appetite control and weight management.

Who may be eligible?

This study is looking for healthy men and women between 18 and 60 years old. You might be eligible if you are in a healthy weight range (BMI between 18.0 and 29.9) or if you have obesity (BMI between 30.0 and 50.0). It's important that you are generally healthy and don't have any major ongoing medical conditions.

You would not be able to join if you have a history of drug or alcohol abuse, or if you smoke. People with conditions like diabetes, certain heart problems, or anaemia are also not suitable for this study. We also can't include those who have recently had big changes in their body weight or are taking medications that might affect the study results. Pregnant or breastfeeding women also cannot 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.

  1. Are you between 18 and 60 years old?
  2. Do you generally feel healthy?
  3. Do you not smoke or have you quit over 2 years ago?
  4. Do you not have diabetes, serious heart problems, or anaemia?
  5. Are you not pregnant or breastfeeding?
  6. Have you not had a significant change in your weight recently (more than 5% in 3 months)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will visit the study centre on four separate days. On each visit, you'll be asked to fast overnight. Then, you'll drink a liquid meal. Each visit will involve a different sized meal (from no calories to a larger meal). Over the four visits, you will have tried all the different meal sizes.

After you drink the meal, the study team will take several blood samples over about three hours to check your hormone levels. You'll also be asked about how hungry or full you feel at different times. A few hours after the liquid meal, you'll be offered a buffet lunch, and the team will record how much you eat. The total time for each visit is a few hours, and all four visits will be scheduled in a random order over a period of time.

Potential risks and benefits

Taking part in a study like this might have some small benefits, such as contributing to scientific knowledge about appetite and weight regulation, which could help others in the future. You might also learn a bit more about your own body's responses. The main risks involve the discomfort of having blood samples taken and potential side effects like bruising from the needle. You might also feel hungry during the fasting period. You are free to withdraw from 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.
  • PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What are gut hormones?

Gut hormones are chemical messengers released by your digestive system that can influence your appetite, how full you feel, and how your body uses energy.

What is LEAP2?

LEAP2 is a hormone found in your gut and liver that is believed to help reduce your appetite and work against the hunger hormone ghrelin.

What is ghrelin?

Ghrelin is a hormone made in your stomach that signals to your brain that you are hungry and increases your appetite.

Will I have to stay overnight?

No, you will not have to stay overnight. Each study visit will involve attending for a few hours after an overnight fast.

Will I know my hormone levels?

The study aims to understand broad patterns of hormone levels but will not be providing individual results to participants.

How to find out more

Tony Goldstone, MRCP PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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