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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT03743792
Eligibility Criteria:
Inclusion Criteria:
* BMI between 27 and 35 kg/m2 and/or waist circumference (\>35 inches for women, \>40 inches for men)
* Aged 55-70 years old
* Able to provide informed consent and comply with study procedures
* Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
* Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
Exclusion Criteria:
* Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped \>2 years
* Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders
* Have recent surgery or injury to head
* Mini-Mental Status Exam score \< 24 or Beck Depression Inventory score \> 20
* Taking any medications that would interfere with outcomes of the study (i.e., lipid- lowering medications, anti-inflammatory drugs, and supplements, not including multivitamin/mineral or calcium/Vit D supplements),
* Unstable use of any medication/supplement
* Have a history of cancer in the prior 5 years, except for non-melanoma skin cancer
* Addicted to drugs and/or alcohol (\>2 drinks/day)
* Have been exposed to any non-registered drug product within last 30 days.
* Working overnight (e.g. 3rd shift of overnight workers)
* Excessive exercisers or trained athletes
* Have allergies/intolerances to berries.
* Vegetarian/vegan or have extreme dietary habits.
* Excessive coffee/tea drinker
* Actively losing weight/ trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months)
* Donated blood within last 3 months
* Female who is pregnant, planning to be pregnant, breastfeeding
* Current regular consumption of berries which exceeds \> 2 servings per day
* The individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT03743792
Study Brief:
Protocol Section:
NCT03743792