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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT02557334
Eligibility Criteria:
Inclusion Criteria:
1. Men and women 35-65 years of age
2. BMI ≥ 25 and ≤ 39 kg/m\^2
3. LDL-C \> 116 mg/dL
4. Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
5. Triglycerides below 350 mg/d
6. Non-smokers
7. Blood pressure \< 160/100 mmHg
Exclusion Criteria:
1. History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided)
2. History of diabetes mellitus (and/or a fasting glucose \> 126 mg/dL at screening)
3. Stage II hypertension (blood pressure ≥ 160/100 mmHg)
4. Lactation, pregnancy, or desire to become pregnant during the study
5. Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless approved by investigator
6. Use of medications/supplements for elevated lipids, blood pressure, or glucose
7. Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication
8. Conditions requiring the use of steroids
9. Unwillingness to refrain from blood donation prior to and during the study
10. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
11. Allergy or sensitivity to strawberries or any ingredient in the study powders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT02557334
Study Brief:
Protocol Section:
NCT02557334