Actively Recruiting
Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
Led by Imperial College London · Updated on 2024-06-26
30
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, including compliance with study requirements
- Able to read, comprehend, and record information written in English
You will not qualify if you...
- History of or current abuse or dependence on alcohol or drugs
- Current smoker or quit smoking less than 2 years ago or use of nicotine replacement therapy
- Significant current or past medical or psychiatric history that contraindicates participation
- History of type 1 or type 2 diabetes mellitus
- History of ischemic heart disease, heart failure, arrhythmia, peripheral vascular, cerebrovascular disease, or uncontrolled hypertension
- Current diagnosis of anemia or iron deficiency
- Body weight change greater than 5% in the last 3 months
- Use of medications that may affect safety or study outcomes
- Clinically significant abnormal blood tests including liver function or thyroid issues
- Current pregnancy or breastfeeding
- Pulse rate less than 40 or greater than 100 bpm or abnormal blood pressure readings
- Participation in other clinical trials with investigational products recently
- Exposure to more than 3 new investigational products in the last 12 months
- Vegan, gluten, or lactose intolerance
- Blood donation within 3 months before or after study visits
- Known COVID-19 infection in last 4 weeks
- Ongoing symptoms from previous COVID-19 infection
- High score on eating disorder questionnaire
- Mild alcohol use disorder by DSM-V criteria
- Previous obesity surgery or current obesity medications
- High restrained eating behavior score on questionnaire
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
London, United Kingdom, W12 0NN
Actively Recruiting
Research Team
T
Tony Goldstone, MRCP PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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