Hypercholesterolemia Clinical Trial
— STR4Official title:
The Cholesterol Lowering Effects of Strawberry: A Randomized Controlled Trial Establishing Strawberry's Role in Cardiovascular Health
Verified date | January 2021 |
Source | Clinical Nutrition Research Center, Illinois Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary objective is to assess strawberry intake on LDL cholesterol and its association with atherosclerosis development.
Status | Completed |
Enrollment | 46 |
Est. completion date | October 31, 2018 |
Est. primary completion date | July 16, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 69 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Nutrition Research Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Center, Illinois Institute of Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in plasma total cholesterol in 4-week intervention of strawberries vs control treatment. | plasma total cholesterol | 4 weeks | |
Other | Changes in plasma HDL cholesterol in 4-week intervention of strawberries vs control treatment. | plasma HDL cholesterol | 4 weeks | |
Other | Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment. | plasma triglycerides | 4 weeks | |
Other | Changes in plasma glucose in 4-week intervention of strawberries vs control treatment. | plasma glucose | 4 weeks | |
Other | Changes in plasma insulin in 4-week intervention of strawberries vs control treatment. | plasma insulin | 4 weeks | |
Other | Changes in plasma C-Reactive Protein in 4-week intervention of strawberries vs control treatment | plasma C-Reactive Protein | 4 weeks | |
Primary | Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment. | plasma LDL cholesterol | 4 weeks | |
Secondary | Changes in endothelial function as measured by Flow Medicated Vasodilation (FMD) in 4-week intervention of strawberries vs control treatment. | endothelial function as measured by Flow Medicated Vasodilation (FMD) | 4 weeks |
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