NCT02612090

The Cholesterol Lowering Effects of Strawberry

The Cholesterol Lowering Effects of Strawberry: A Randomized Controlled Trial Establishing Strawberry's Role in Cardiovascular Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

Summary

Primary objective is to assess strawberry intake on LDL cholesterol and its association with atherosclerosis development.

Detailed description

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.

Conditions

• Hypercholesterolemia
• Glycemic Response

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Treatment Beverage	Strawberry
DIETARY_SUPPLEMENT	Placebo Treatment Beverage	Placebo

Timeline

• Start date: 2016-01-04
• Primary completion: 2017-07-16
• Completion: 2018-10-31
• First posted: 2015-11-23
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States