The Effects of Strawberries on Blood Cholesterol.

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Hyper-LDL-cholesterolemia
• Intervention / Treatment: Other: Control powder; Dietary supplement: strawberries

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • University of Nevada at Las Vegas
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center, OCTSI
    • Stillwater, Oklahoma, United States, 74078
      • Oklahoma State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Collaborators: University of Oklahoma; Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 1119274

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No