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Primary objective is to assess strawberry intake on LDL cholesterol and its association with atherosclerosis development.
The trial is designed as a randomized, 2-arm, 2-sequence, within-subject, cross-over, chronic feeding study. The arms of the study will include regular consumption of a strawberry or strawberry-placebo powder equivalent to ~3.5 servings of strawberries/day (50g) freeze-dried strawberry powder (provided twice a day, 25 grams each time >6h apart).
A planned sample size of 50 men and women will be enrolled into the study. This study will require one initial screening visit, 4 study visits, and 6 weekly visits. This study will take approximately 12 weeks per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood draw, and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at the Screening Visit and collected before study day 1 to assess subjects' baseline dietary intake pattern. Subjects will be instructed to follow a strictly limited polyphenolic diet for 7 days prior to the study and throughout their participation time, while maintaining their usual diet pattern and physical activity, with counseling by staff investigator and/or Registered Dietitian. A dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health care professional will take a fasting blood draw with a butterfly needle. Subjects will be randomized to receive a placebo or treatment beverage based on randomized treatment sequences at 4 study visits. The sequences of receiving the beverage treatments at each visit will be randomly assigned to one of two of following sequences: placebo- treatment beverage or treatment beverage -placebo.
Each study visit will involve blood sample collection at time points 0h (fasting) for assessment of change in plasma lipid and lipoprotein markers. Each study visit will involve a 2 flow mediated dilatation procedure to assess endothelial function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment Beverage | Active Comparator | Strawberry |
|
| Placebo Treatment Beverage | Placebo Comparator | Placebo Beverage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Treatment Beverage | Dietary Supplement | Strawberry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment. | plasma LDL cholesterol | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma total cholesterol in 4-week intervention of strawberries vs control treatment. | plasma total cholesterol | 4 weeks |
| Changes in plasma HDL cholesterol in 4-week intervention of strawberries vs control treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britt Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33758944 | Derived | Huang L, Xiao D, Zhang X, Sandhu AK, Chandra P, Kay C, Edirisinghe I, Burton-Freeman B. Strawberry Consumption, Cardiometabolic Risk Factors, and Vascular Function: A Randomized Controlled Trial in Adults with Moderate Hypercholesterolemia. J Nutr. 2021 Jun 1;151(6):1517-1526. doi: 10.1093/jn/nxab034. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo Treatment Beverage | Dietary Supplement | Placebo |
|
|
plasma HDL cholesterol
| 4 weeks |
| Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment. | plasma triglycerides | 4 weeks |
| Changes in plasma glucose in 4-week intervention of strawberries vs control treatment. | plasma glucose | 4 weeks |
| Changes in plasma insulin in 4-week intervention of strawberries vs control treatment. | plasma insulin | 4 weeks |
| Changes in plasma C-Reactive Protein in 4-week intervention of strawberries vs control treatment | plasma C-Reactive Protein | 4 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |