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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT03898505
Eligibility Criteria:
Inclusion Criteria:
* adults 18 to 60 years of age
* includes non-pregnant, non-breastfeeding women on adequate birth control
* stable body weight (BMI: 18.5-29.9)
* written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Pregnant or breastfeeding
* History or presence of diabetes
* History or presence of hypertension
* History or presence of dyslipidemia
* History or presence of major depressive disorders
* History or presence of chronic liver disorders
* History or presence of kidney disorders
* History or presence of blood disorders
* Previous bariatric surgery (or any major surgeries or medical procedures to be scheduled within the time frame of the study)
* Use of medication that causes significant weight gain or loss
* Allergies to or inhibitions consuming all three choices of: 2% lactose free milk, soy milk, or coconut milk
* Allergies to any ingredients in the placebo/investigational product
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03898505
Study Brief:
Protocol Section:
NCT03898505