Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorImperial College London
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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 therapy;
Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation;
History of type 1 or type 2 diabetes mellitus;
Trial design
Design model
Crossover
Treatments tested in this trial
0 kcal liquid meal
Dietary supplementFlavoured water, given as one meal at one study visit only
600 kcal liquid meal
Dietary supplementFortisip Compact Vanilla, given as one meal at one study visit only
900 kcal liquid meal (only for group without obesity)
Dietary supplementFortisip Compact Vanilla, given as one meal at one study visit only
1200 kcal liquid meal
Dietary supplementFortisip Compact Vanilla, given as one meal at one study visit only
1800 kcal liquid meal (only for group with obesity)
Dietary supplementFortisip Compact Vanilla, given as one meal at one study visit only
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Healthy adults without obesityExperimental treatment 4 interventions
Group B: Healthy adults with obesityExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Post-prandial plasma concentration acyl ghrelin
Incremental area under curve (iAUC) 0-180 minutes, units: pg/mL.hr
Time frame
0, 30, 60, 120, 180 minutes2
Post-prandial plasma concentration LEAP2
Incremental area under curve (iAUC) 0-180 minutes, units: ng/mL.hr
Time frame
0, 30, 60, 120, 180 minutesSecondary outcomes
1
Visual analogue scale ratings of appetite
Incremental area under curve (iAUC) 0-180 minutes - units: mm.hr
Time frame
0, 30, 60, 120, 180 minutes2
Ad libitum food intake
Total kilocalories eaten as % estimated resting energy expenditure (calculated from bio-impedance analysis determined fat free mass using Cunningham equation equating with lean body mass)
Time frame
at 180 minutesSponsors and contacts
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Source ClinicalTrials.gov