Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT06684834
Eligibility Criteria:
Inclusion Criteria:
1. Waist circumference of ≥94 cm (37 inches) if male and ≥80 cm (31.5 inches) if female, or BMI above 25 kg/m2
2. Fat mass index (FMI) of \>6 kg/m2 for males, and \>9 kg/m2 for females
3. Aged between 18-65 years
4. Has maintained a stable weight in the last three months (\<3% change in body mass)
5. Keeps track of menstrual cycle regularity or oral contraceptive use (females only)
Exclusion Criteria:
1. Has a body weight of ≥120kg
2. Plans to undertake other lifestyle modifications during the study to manage weight (e.g. changes in dietary intake or activity levels)
3. Current or previous eating disorder
4. Diagnosed with major chronic conditions (e.g. type 2 diabetes, coronary heart disease, cancer, chronic kidney disease, etc.)
5. Use of medication that may interfere with study outcomes (e.g. glucose or lipid lowering medications)
6. Currently or recently pregnant (within last 6 months), planning to get pregnant or currently lactating
7. Has donated more than 500ml of blood in the last 3 months prior to the initial laboratory visit
8. Insufficient mental capacity or language skills to independently understand and follow the study protocol
9. Dietary restrictions to ingredients in test meals (e.g. gluten and lactose)
10. Has an irregular sleeping pattern (e.g. due to undertaking night-shift work)
11. Any condition, concurrent intervention or behaviour deemed either to pose undue personal risk to the participant or to introduce bias into the experiment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06684834
Study Brief:
Protocol Section:
NCT06684834