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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01293604
Eligibility Criteria:
Inclusion Criteria:
* Men and women between the ages of 25-70 years
* Body mass index (BMI) ≥ 19 and ≤ 38
* Willingness and ability to make scheduled appointments at clinical site as required by study protocol
Exclusion Criteria:
* Do not regularly consume breakfast or dislike cereal for breakfast
* Known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)
* Presence of kidney disease, liver disease, gout, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides \> 300 mg/dL
* Fasting glucose \> 126 mg/dL
* Use of cholesterol lowering medication
* Blood pressure \> 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
* History of bariatric or certain other surgeries related to weight control
* History of major surgery within 3 months of enrollment
* Smokers or other tobacco users (during 6 months prior to the start of the study)
* Antibiotic use during the intervention or for 3 months prior to the intervention period
* 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 6 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT01293604
Study Brief:
Protocol Section:
NCT01293604