At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 0 kcal liquid meal (supplement), 600 kcal liquid meal (supplement), 900 kcal liquid meal (only for group without obesity) (supplement), 1200 kcal liquid meal (supplement)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- 0 kcal liquid meal — supplement: Flavoured water, given as one meal at one study visit only · 600 kcal liquid meal — supplement: Fortisip Compact Vanilla, given as one meal at one study visit only · 900 kcal liquid meal (only for group without obesity) — supplement: Fortisip Compact Vanilla, given as one meal at one study visit only · 1200 kcal liquid meal — supplement: Fortisip Compact Vanilla, given as one meal at one study visit only · 1800 kcal liquid meal (only for group with obesity) — supplement: Fortisip Compact Vanilla, given as one meal at one study visit only
- Patient visit burden
- "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." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years to 60 Years
- Who
- All
- Number of participants
- 30
- Started
- 2023-08-29
- Last checked
- 2024-06
Plain English Summary
What is this study?
- • Testing a new treatment for eating behavior
- • NA - 30 participants
- • 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
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with eating behavior
Where?
- • London - PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: All genders
What the study is looking for
- ✓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 agreement to take part, which includes compliance with the requirements and restrictions listed...
- ✓Participant is able to read, comprehend and record information written in English.
Who cannot take part
- ✗History of, or current abuse or dependence on alcohol or drugs;
- ✗Current smoker or less than 2 years since quitting (cigarette, cigars, e-cigarettes) or use of nicotine replacement...
- ✗Significant current or past medical or psychiatric history that, in the opinion of the investigators,...
- ✗History of type 1 or type 2 diabetes mellitus;
- ✗History of ischaemic heart disease, heart failure, heart arrhythmia, peripheral vascular, cerebrovascular disease...
See the full criteria
Where Is This Study? (1 UK site)
PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
London W12 0NN, United Kingdom
How to Get in Touch
Tony Goldstone, MRCP PhD
Sponsor contactCONTACT
