The Effects of Strawberries on Blood Cholesterol.

Nevada System of Higher Education (NSHE)

Status: Completed

Conditions: Hyper-LDL-cholesterolemia; Metabolic Syndrome

Treatments: Dietary Supplement: strawberries; Other: Control powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03441620

1119274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elevated total and LDL cholesterol (>116 mg/dL)
• body mass index (> or = 30 kg/m2)
• features of the metabolic syndrome

Exclusion criteria

• taking glucose and lipid lowering medications (e.g. statins, metformin)
• history of chronic conditions (diabetes, CHD, anemia, renal diseases)
• allergic to strawberries
• pregnant and/or lactating
• smoking
• vegetarian or consuming special diet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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33 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Calorie and fiber-matched control powder

Treatment:

Other: Control powder

Strawberry one serving

Experimental group

Description:

Freeze-dried powder equivalent to one serving fresh strawberries per day.

Treatment:

Dietary Supplement: strawberries

Strawberry two-half servings

Experimental group

Description:

Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.

Treatment:

Dietary Supplement: strawberries