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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT03921333
Eligibility Criteria:
Inclusion criteria
* Females and males, aged 18 years to 65 years
* Body Mass Index (BMI) 27-35 kg/m2
* Not dieting within the last month and not having lost \>5% body weight in the previous year
* Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
* Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
* Able to eat most everyday foods
* Habitually consumes three standard meals a day (i.e. breakfast, lunch and dinner)
Exclusion criteria
* Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
* Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study
* Pregnant, planning to become pregnant or breastfeeding
* History of anaphylaxis to food
* Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
* BMI \<27 kg/m2 or \>35 kg/m2
* Volunteers self-reporting currently dieting or having lost \>5% body weight in the previous year
* Participants with abnormal eating behaviour
* Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit
* Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
* Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
* Participants on specific food avoidance diets
* Participants who work in appetite or feeding related areas
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03921333
Study Brief:
Protocol Section:
NCT03921333