Eating BehaviorLEAP2-mealNCT06013592
Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
A study testing 0 kcal liquid meal, 600 kcal liquid meal and 900 kcal liquid meal (only for group without obesity) in people with Eating Behavior and Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Obesity, Appetitive Behavior
- What is being tested?
- 0 kcal liquid meal, 600 kcal liquid meal and 900 kcal liquid meal (only for group without obesity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Aug 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
- History of ischaemic heart disease, heart failure, cardiac arrhythmia, peripheral vascular, cerebrovascular disease or uncontrolled hypertension;
- Current diagnosis of anaemia or iron deficiency;
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- Body weight instability (change in body weight of more than 5% over the preceding 3 months);
- Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures;
- Clinically significant abnormalities in screening blood tests abnormalities which in the opinion of the study physician, is clinically significant e.g. diabetes mellitus, hypothyroidism, renal impairment, abnormal liver function tests [bilirubin, alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT)] >3x upper limit of normal, other than due to fatty liver disease; Current pregnancy or breast-feeding in female volunteers (the Investigators will recommend using contraception for the duration of the visits to avoid participant drop-out);
- Pulse rate <40 or >100 beats per minute OR systolic blood pressure >160 and <100 OR diastolic blood pressure >95 and <50 in the semi-supine position;
- Volunteer has participated in a clinical trial and has received an investigational product within the following time period prior to the first experimental visit in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
- Exposure to more than 3 new investigational medicinal products within 12 months prior to the scan;
- Vegan, gluten or lactose-intolerant (as test meals in the paradigms may include animal products, dairy and wheat products);
- Volunteers who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion;
- Known history of SARS-CoV-2 infection (Covid-19) in the last 4 weeks;
- Ongoing symptoms suggestive of complications from previous SARS-CoV-2 infection ('long Covid-19') such as loss or change in sense of smell or taste, shortness of breath, palpitations, lethargy;
- SCOFF questionnaire score >1/5 indicating eating disorders (Luck et al. 2002);
- DSM-V criteria for alcohol use disorder (AUD) >2/11 indicating mild AUD (American-Psychiatric-Association 2013);
- Participants who have had previous obesity surgery or are on medications for obesity;
- Dutch Eating Behaviour Questionnaire (DEBQ) restraint score >3/5 indicating highly restrained eating behaviour.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London
London, W12 0NN
Tony Goldstone, MRCP PhD, +44 20 7594 5989, tony.goldstone@imperial.ac.uk
About this study
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.
Read more
The main study questions are:
- 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)?
- 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?
- 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?
- 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
- Eating Behavior, Obesity, Appetitive Behavior
- Being tested
- 0 kcal liquid meal, 600 kcal liquid meal, 900 kcal liquid meal (only for group without obesity), 1200 kcal liquid meal, 1800 kcal liquid meal (only for group with obesity)
- Keywords
- LEAP2, ghrelin, appetite, food intake, eating behaviour
- Medical subject headings
- Feeding Behavior, Obesity, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 kcal liquid mealDietary supplement
Flavoured water, given as one meal at one study visit only
600 kcal liquid mealDietary supplement
Fortisip Compact Vanilla, given as one meal at one study visit only
900 kcal liquid meal (only for group without obesity)Dietary supplement
Fortisip Compact Vanilla, given as one meal at one study visit only
1200 kcal liquid mealDietary supplement
Fortisip Compact Vanilla, given as one meal at one study visit only
1800 kcal liquid meal (only for group with obesity)Dietary supplement
Fortisip Compact Vanilla, given as one meal at one study visit only
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults without obesity | Experimental | Liquid meals with different caloric sizes (0, 600, 900, 1200 kcal) in within-participant cross-over design Receives: Dietary Supplement: 0 kcal liquid meal; Dietary Supplement: 600 kcal liquid meal; Dietary Supplement: 900 kcal liquid meal (only for group without obesity); Dietary Supplement: 1200 kcal liquid meal |
| Healthy adults with obesity | Experimental | Liquid meals with different caloric sizes (0, 600, 1200, 1800 kcal) in within-participant cross-over design Receives: Dietary Supplement: 0 kcal liquid meal; Dietary Supplement: 600 kcal liquid meal; Dietary Supplement: 1200 kcal liquid meal; Dietary Supplement: 1800 kcal liquid meal (only for group with obesity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial plasma concentration acyl ghrelin
Incremental area under curve (iAUC) 0-180 minutes, units: pg/mL.hr
Measured: 0, 30, 60, 120, 180 minutes
Post-prandial plasma concentration LEAP2
Incremental area under curve (iAUC) 0-180 minutes, units: ng/mL.hr
Measured: 0, 30, 60, 120, 180 minutes
Secondary outcomes (2)
Visual analogue scale ratings of appetite
Incremental area under curve (iAUC) 0-180 minutes - units: mm.hr
Measured: 0, 30, 60, 120, 180 minutes
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)
Measured: at 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start29 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- within participant
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony Goldstone, MRCP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013592
- Sponsor's protocol ID
- 23HH8298
- Acronym
- LEAP2-meal
- Status last verified
- Jun 2024
- First submitted
- 22 Aug 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
- ClinicalTrials.gov ID
- NCT06013592
- Acronym / sponsor ID
- LEAP2-meal / 23HH8298
- Conditions
- Eating Behavior, Obesity, Appetitive Behavior
- Keywords
- LEAP2, ghrelin, appetite, food intake, eating behaviour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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?
- 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?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- within participant
| Arm | Type | Receives |
|---|---|---|
| Healthy adults without obesity | Experimental | Dietary Supplement: 0 kcal liquid meal, Dietary Supplement: 600 kcal liquid meal, Dietary Supplement: 900 kcal liquid meal (only for group without obesity), Dietary Supplement: 1200 kcal liquid mealLiquid meals with different caloric sizes (0, 600, 900, 1200 kcal) in within-participant cross-over design |
| Healthy adults with obesity | Experimental | Dietary Supplement: 0 kcal liquid meal, Dietary Supplement: 600 kcal liquid meal, Dietary Supplement: 1200 kcal liquid meal, Dietary Supplement: 1800 kcal liquid meal (only for group with obesity)Liquid meals with different caloric sizes (0, 600, 1200, 1800 kcal) in within-participant cross-over design |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
- History of ischaemic heart disease, heart failure, cardiac arrhythmia, peripheral vascular, cerebrovascular disease or uncontrolled hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0 kcal liquid mealFlavoured water, given as one meal at one study visit only | Dietary supplement | Healthy adults with obesity, Healthy adults without obesity |
| 600 kcal liquid mealFortisip Compact Vanilla, given as one meal at one study visit only | Dietary supplement | Healthy adults with obesity, Healthy adults without obesity |
| 900 kcal liquid meal (only for group without obesity)Fortisip Compact Vanilla, given as one meal at one study visit only | Dietary supplement | Healthy adults without obesity |
| 1200 kcal liquid mealFortisip Compact Vanilla, given as one meal at one study visit only | Dietary supplement | Healthy adults with obesity, Healthy adults without obesity |
| 1800 kcal liquid meal (only for group with obesity)Fortisip Compact Vanilla, given as one meal at one study visit only | Dietary supplement | Healthy adults with obesity |
Primary outcome
Post-prandial plasma concentration acyl ghrelin
Time frame: 0, 30, 60, 120, 180 minutes
Incremental area under curve (iAUC) 0-180 minutes, units: pg/mL.hr
Post-prandial plasma concentration LEAP2
Time frame: 0, 30, 60, 120, 180 minutes
Incremental area under curve (iAUC) 0-180 minutes, units: ng/mL.hr
2 secondary outcomes
Visual analogue scale ratings of appetite
Time frame: 0, 30, 60, 120, 180 minutes
Ad libitum food intake
Time frame: at 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Goldstone, MRCP PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0 kcal liquid meal, 600 kcal liquid meal and 900 kcal liquid meal (only for group without obesity) in people with Eating Behavior and Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Goldstone, MRCP PhD (+44 20 7594 5989, tony.goldstone@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial plasma concentration acyl ghrelin (time frame: 0, 30, 60, 120, 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.