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 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT02310334
Eligibility Criteria:
Inclusion Criteria:
* Male and Female
* Ages 18 to 29 at the beginning of the study
* Relatively fit can run 2 miles in under 16 minutes
Exclusion Criteria:
* History of Skin Sensitivity to Nickel
* Hypertension
* Alcoholism
* Diabetes
* Pregnant
* Age \>29
* Cannot run 2 miles in less than 16 minutes
* No regular weekly exercise
* Difficulty Swallowing Food or Large Pills
* Diverticulitis
* Inflammatory Bowel Disease
* Peptic Ulcer Disease
* Crohn's Disease
* Ulcerative Colitis
* Previous Gastrointestinal Surgery
* Possible Nuclear Magnetic Resonance Scan
* Women who have given birth during the previous 12 months
* Pregnant women or women who plan to become pregnant or become pregnant during the study
* Lactating women
* History or presence of kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (for at least 6 months prior to the start of the study)
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
* Unable or unwilling to give informed consent or communicate with study staff.
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Blood donation within the previous month
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
29 Years
Study:
NCT02310334
Study Brief:
Protocol Section:
NCT02310334