NCT03441620

The Effects of Strawberries on Blood Cholesterol.

Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.

Detailed description

The screen visit will involve an 8 hour fasting state and the following procedures: * Completing screening questionnaire * Measuring height, weight, blood pressure, and waist size * Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel \[PI \&Co-PI: Basu, Izuora and graduate student\]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.

Conditions

• Hyper-LDL-cholesterolemia
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	strawberries	Freeze-dried strawberry powder
OTHER	Control powder	Control powder matched for fiber and strawberries

Timeline

• Start date: 2018-02-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2018-02-22
• Last updated: 2021-03-16

Locations

3 sites across 1 country: United States