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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this interventional study is to measure the blood levels of the gut hormones LEAP2 and acyl ghrelin (AG), appetite and food intake after consuming liquid meals of different caloric sizes, in healthy adults with and without obesity. AG is a stomach-derived homone that increases appetite, and LEAP2 a liver-gut derived hormone that decreases appetite, which interferes the action of AG ant its receptor in the brain called the growth hormone secretagogue receptor (GHSR). Blood levels of AG and LEAP2 change in opposite directions after food intake (AG decreasing, LEAP2 increasing). AG is formed from an inactive version of hormone called desacyl ghrelin (DAG). Previous studies have shown that greater food intake leads to a greater decrease in blood levels of total ghrelin (AG + DAG), but this has not been studied for changes in blood AG or LEAP2 after eating. Blood levels of AG and total ghrelin when fasted and after food intake are lower, while blood levels of LEAP2 are higher, in adults with than those without obesity. The main study questions are: 1. Are there greater increases in blood levels of LEAP2 and greater decreases in blood levels of AG after consuming larger meals (by amount of calories they contain)? 2. Are greater decreases in appetite after connsuming larger meals related to greater increases in blood levels of LEAP2 and greater decreases in blood levels of AG? 3. Are greater decreases in food intake at a buffet lunch after consuming larger meals eaten a few hours previously related to greater increases in blood levels of LEAP2 and greater decreases in blood levels of AG? 4. Do the above findings differ between adults without obesity and with obesity? At each of 4 study days, healthy adults (without and with obesity) will consume one size of a single liquid meal containing different amounts of calories (0, 600, 900 (group without obesity only), 1200, 1800 (group with obesity only) kilocalories, of identical total volume) after an overnight fast and have measurements of blood LEAP2 and AG and appetite ratings from 0 to 180 min, and have food intake at an ad libitum lunch measured at 180 mins. Food will be weighed and converted into kilocalories. All participants will attend for all 4 study visits in a randomised order to receive one of the meal sizes at each visit, so that all 4 meal zizes are consumed over all 4 study visits: 0, 600, 900 (group without obesity), 1200, 1800 (group with obesity) kcal.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Male or female between the ages of 18 and 60 years;

• Without obesity with body mass index (BMI) 18.0-29.9 kg/m2 or with obesity with BMI 30.0-50.0 kg/m2;

• Healthy as determined by medical history and vital signs;

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;

• Participant is able to read, comprehend and record information written in English.

Locations
Other Locations
United Kingdom
PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
RECRUITING
London
Contact Information
Primary
Tony Goldstone, MRCP PhD
tony.goldstone@imperial.ac.uk
+44 20 7594 5989
Time Frame
Start Date: 2023-08-29
Estimated Completion Date: 2025-08
Participants
Target number of participants: 30
Treatments
Experimental: Healthy adults without obesity
Liquid meals with different caloric sizes (0, 600, 900, 1200 kcal) in within-participant cross-over design
Experimental: Healthy adults with obesity
Liquid meals with different caloric sizes (0, 600, 1200, 1800 kcal) in within-participant cross-over design
Related Therapeutic Areas
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov