The Cholesterol Lowering Effects of Strawberry
Completed · Not applicable · Has a placebo group
Conditions studied: Hypercholesterolemia, Glycemic Response
In brief
Primary objective is to assess strawberry intake on LDL cholesterol and its association with atherosclerosis development.
Key facts
- Study ID
- NCT02612090
- Run by
- Clinical Nutrition Research Center, Illinois Institute of Technology
- People needed
- 46
- Starts
- 2016-01-04
- Expected to finish
- 2018-10-31
- Last updated by the study team
- 2021-01-27
Who can join
Age: 40 and older, up to 69. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Men and post-menopausal women (without menses for 1 year) with moderate hypercholesterolemia as defined by LDL cholesterol between 115mg/dl-165mg/dl and total cholesterol >160mg/dl preferred but not to exceed 240mg/dl
- 40-69 years of age
- Body Mass Index (BMI) range from 25 to 38.9 kg/m2
- Nonsmoker
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc…
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol
- Weight stable: not gained or lost weight +/- 5 kg in previous 3 months
You may not qualify if…
- Men and women who smoke
- Past smokers: abstinence for minimum 2 years
- Men and women with known or suspected food intolerance, allergies or hypersensitivity
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations > 110mg/dL
- Men and women who have uncontrolled blood pressure >120 mmHg/80 mmHg
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc...
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are breast-feeding
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
- Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Men and women who are vegans
- Substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumers (> 4 cups/d) and polyphenol consumers (>2 cups fresh/day
- Men and women who do excessive exercise regularly or athlete
- Unstable weight: gained or lost weight +/- 5 kg in previous 3 months
- Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.
Where it is running
- Clinical Nutrition Research Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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