Examining gut hormones and their effects on appetite and food intake
Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing
This study is testing how certain gut hormones affect hunger and food intake in healthy adults with and without obesity after they drink meals of different calorie sizes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06013592 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to measure the blood levels of gut hormones LEAP2 and acyl ghrelin in healthy adults with and without obesity after consuming liquid meals of varying caloric sizes. The study will assess how these hormones influence appetite and food intake, particularly focusing on the opposing actions of LEAP2, which decreases appetite, and acyl ghrelin, which increases it. Participants will consume liquid meals ranging from 0 to 1800 kcal, depending on their obesity status, to evaluate the hormonal responses. The findings could provide insights into the mechanisms of appetite regulation and obesity.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 60, with or without obesity.
Not a fit: Patients with a history of diabetes or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for managing obesity and eating behaviors through hormonal interventions.
How similar studies have performed: Previous studies have indicated hormonal influences on appetite, but this specific approach to measuring LEAP2 and acyl ghrelin responses to meal intake is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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.
Where this trial is running
London
- PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Tony Goldstone, MRCP PhD — Imperial College London
- Study coordinator: Tony Goldstone, MRCP PhD
- Email: tony.goldstone@imperial.ac.uk
- Phone: +44 20 7594 5989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.