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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study how the gut hormones LEAP2 and acyl ghrelin (AG) affect appetite and eating behavior in healthy adults with and without obesity. LEAP2 is known to decrease appetite while AG increases it, and both hormones change in opposite ways after eating. The study explores whether larger meals cause greater changes in these hormone levels and how these changes relate to appetite and food intake. Researchers also want to understand if these effects differ between adults who are obese and those who are not. Participants will attend four study visits where they consume a single liquid meal of varying calorie amounts after fasting overnight. The meals range from 0 to 1800 kilocalories, with some meal sizes specific to either the group without obesity or the group with obesity. The order of meal sizes is randomized for each participant. At each visit, blood levels of LEAP2 and AG will be measured at multiple time points after eating, and appetite ratings will be recorded. After three hours, participants will have an unrestricted buffet lunch where their food intake is measured. During the study, participants will have blood samples taken at 0, 30, 60, 120, and 180 minutes after the meal to measure hormone levels. Appetite will also be assessed at these times. Food intake at the buffet lunch is tracked by weighing food consumed. Participants are monitored for safety through health history and vital signs, and their ability to understand and comply with study procedures is ensured. Total participation involves attending all four randomized visits, with each visit involving a different meal size to compare effects on hormones and appetite.
CONDITIONS
Brief 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
- Body mass index (BMI) 18.0-29.9 kg/m2 for those without obesity or 30.0-50.0 kg/m2 for those with obesity
- Healthy as determined by medical history and vital signs
- Able to give written informed consent and comply with study requirements
- Able to read, understand, and record information 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 conditions that prevent safe participation
- History of type 1 or type 2 diabetes
- History of heart disease, heart failure, arrhythmia, vascular, cerebrovascular disease, or uncontrolled hypertension
- Current diagnosis of anemia or iron deficiency
- Body weight changed by more than 5% in the last 3 months
- Use of medications that may affect safety or study outcomes
- Clinically significant abnormal blood tests (e.g., diabetes, thyroid, kidney, liver issues)
- Pregnancy or breastfeeding
- Abnormal pulse or blood pressure outside set limits
- Participation in another clinical trial with investigational product within the past 90 days or more
- Exposure to more than 3 new investigational drugs in past 12 months
- Vegan or intolerant to gluten or lactose
- Donated or planning to donate blood within 3 months before or after study
- Known COVID-19 infection in last 4 weeks or ongoing related symptoms
- Eating disorder indicated by SCOFF questionnaire score above 1
- Alcohol use disorder indicated by DSM-V criteria above 2
- Previous obesity surgery or current obesity medications
- Highly restrained eating behavior indicated by DEBQ score above 3 out of 5
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each meal given at one study visit; study includes multiple meal visits over the course of the trial
Participants receive different sized liquid meals in a randomized crossover design to measure hormone responses and eating behaviour.
4 to 5 visits depending on obesity status
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
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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