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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01416051
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects of both sexes 18 - 60 years of age
* body mass index (BMI) between 25 and 40 kg/m2, inclusive
Exclusion Criteria:
* (1) participation in another clinical trial or receipt of an investigational product 30 days prior to enrollment
* (2) a dietary restraint score of \> 13
* (3) weight loss of 4.5 kg or more in the preceding three months
* (4) use of tobacco products, nicotine gum or nicotine patch
* (5) a medical condition or taking regular medication except oral contraceptives and hormone replacement therapy
* (6) use of a nutritional product or dietary supplement or program which might interfere with the conduct of the study or place the subject at risk
* (7) history of alcohol or other drug abuse in the preceding one year
* (8) pregnancy, lactation, post-partum less than six months, planning a pregnancy during the study or not using an acceptable method of contraception
* (9) fasting blood sugar ≥ 126 mg/dl
* (10) known allergy or sensitivity to any ingredient in the supplement
* (11) clinically significant deviations in normal laboratory values
* (12) irregular meal-times, and
* (13) unwilling to eat yogurt at test meals.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01416051
Study Brief:
Protocol Section:
NCT01416051