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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01478659
Eligibility Criteria:
Inclusion Criteria:
* Adults 18 to 50 years of age
* Internet access for the duration of the protocol
* BMI of 23.0 to \< 30 kg/m2
* Usual fiber intake of \<20 g/d based on FFQ such as the Block Fruit/Vegetable/Fiber Screener
* Weight stable (±5 lbs. last 3 months)
* Assessment of normal eating determined by the Eating Inventory
* Willing to eat yogurt and a granola-like snack bar daily for 8 weeks
* Willing to complete daily questionnaires and 28 dietary recalls over the 8 weeks
* Habitual breakfast consumer defined as eating breakfast (any food within 2 hours of waking) 5 or more days a week
* Willing to provide a social security number to receive study payment
Exclusion Criteria:
* Post-menopausal (self-reported no menstrual period for one year)
* Current smokers or tobacco users
* Based on Automated Self-Administered Diet History (ASA24) dietary intake data collected during pre-baseline period: Females eating less than 1200 kcal/day, males eating less than 1500 kcal/day or either or greater than 4000 kcal per day, consuming on average greater than 10 g dietary fiber/1000 kcal
* Unwilling to discontinue any prebiotic and fiber supplements, or probiotic supplement
* Antibiotic use within 2 months from study start
* Known food allergies
* Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
* Taking prescribed medications other than oral contraceptives, seasonal allergy medications, cholesterol or blood pressure lowering medications, vitamins or minerals, baby aspirin
* Intake of \>2 alcoholic drinks per day on average
* Purposeful exercise of \>300 minutes per week on average
* Women who are lactating or know they are pregnant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01478659
Study Brief:
Protocol Section:
NCT01478659