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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT02885935
Eligibility Criteria:
Inclusion Criteria:
* Men and women, ages 45-75 years AND
* BMI greater than 30 kg/m2 AND
* Two of the following conditions:
* Plasma triglycerides \> 130 mg/dl
* HDL \< 40 mg/dl in men or 50 mg/dl in women
* elevated screening blood pressure (systolic \> 140 or diastolic \>90 mm Hg) or taking medication for hypertension
* fasting plasma glucose \> 100mg/dl
Exclusion Criteria:
* Hemoglobin A1c \> 7.5
* History of malignancy in the 6 months prior to enrollment
* History of lactose intolerance or dairy allergy
* History of gastrointestinal bypass surgery (Lapband, etc)
* History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
* Subjects who do not or will not eat animal proteins
* Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
* Subjects who use insulin to control their blood sugar
* Subjects whose physician will not allow suspension of oral diabetes medications for the duration of the study (\~5 weeks)
* Concomitant use of corticosteroids (ingestion, injection or transdermal)
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT02885935
Study Brief:
Protocol Section:
NCT02885935