The Cholesterol Lowering Effects of Strawberry (STR4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02612090|
Recruitment Status : Active, not recruiting
First Posted : November 23, 2015
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Glycemic Response||Dietary Supplement: Active Treatment Beverage Dietary Supplement: Placebo Treatment Beverage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Cholesterol Lowering Effects of Strawberry: A Randomized Controlled Trial Establishing Strawberry's Role in Cardiovascular Health|
|Actual Study Start Date :||January 4, 2016|
|Estimated Primary Completion Date :||May 4, 2019|
|Estimated Study Completion Date :||May 4, 2019|
Active Comparator: Active Treatment Beverage
Dietary Supplement: Active Treatment Beverage
Other Name: Active Comparator
Placebo Comparator: Placebo Treatment Beverage
Dietary Supplement: Placebo Treatment Beverage
Other Name: Placebo Comparator
- Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in endothelial function as measured by Flow Medicated Vasodilation (FMD) in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in plasma total cholesterol in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in plasma HDL cholesterol in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in plasma glucose in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in plasma insulin in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
- Changes in plasma C-Reactive Protein in 4-week intervention of strawberries vs control treatment [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612090
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|Principal Investigator:||Britt Britt Burton-Freeman, Ph.D||Illinois Institute of Technology|