The Effects of Strawberries on Blood Cholesterol.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyper-LDL-cholesterolemia, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: strawberries
* Other: Control powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Calorie and fiber-matched control powder | Other: Control powder<br>* Control powder matched for fiber and strawberries<br>|
| Experimental: Strawberry one serving<br>Freeze-dried powder equivalent to one serving fresh strawberries per day. | Dietary Supplement: strawberries<br>* Freeze-dried strawberry powder<br>|
| Experimental: Strawberry two-half servings<br>Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day. | Dietary Supplement: strawberries<br>* Freeze-dried strawberry powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lipid profiles | Serum LDL, total and HDL cholesterol, triglycerides | 14 weeks | 
| Glycemic control | Blood glucose | 14 weeks | 
| Serum lipid particle concentrations | Molar concentrations of serum lipids and particle size | 14 weeks | 
| Diabetes control | Insulin resistance | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Inflammation | Serum C-reactive protein and adipokines | 14 weeks | 
| Systemic Anthocyanins | Strawberry anthocyanin metabolites measured in serum | 14 weeks | 
| Serum metabolomics | primary and lipid metabolites in serum | 14 weeks |