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:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT03235804
Eligibility Criteria:
Inclusion Criteria:
* Non-smoker;
* Female/Male;
* Aged 18 to 50 years;
* Body mass index (BMI) between 25 and 37 kg/m²;
* Weight stable (\< ± 5 kg over past 6 months);
* Fat mass ≥20% for men and ≥25% for women;
* Maintaining current levels of physical activity throughout the study.
* Female participants must verify use of acceptable, effective birth control methods (total abstinence, hormonal birth control \[oral, injectable, transdermal, intravaginal\], intrauterine devices, confirmed successful vasectomy or partner, or condoms).
Exclusion Criteria:
* Diagnosis of chronic diseases or acute infections;
* Taking any medication that may alter inflammation, energy metabolism, body weight and composition, gut microbiota and hormone levels; investigators should always be informed if there are any changes in medications or Natural health product use;
* Taking pre- and probiotics (e.g. supplements);
* Use of antibiotics in the past two months;
* Use of thyroid replacement therapy;
* Use of nutritional supplements in the past four weeks (multivitamin and vitamin D3 are permitted to be used during the course of the study);
* Allergy to any ingredient (including non-medicinal ingredients) in investigational product;
* Lactose, gluten and/or soy allergic/intolerant;
* Follow a vegetarian, vegan or any restrictive dietary pattern;
* Pregnant or lactating;
* Perform over three hours of vigorous physical activity per week;
* A nuclear medicine scan or injection of an X-ray dye in the past week;
* A barium test/exam in the last two weeks;
* Suffer from claustrophobia;
* Inability to comprehend and complete the required questionnaires.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03235804
Study Brief:
Protocol Section:
NCT03235804