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OpenTrials
Completed

NCT Number: NCT03441620

The Effects of Strawberries on Blood Cholesterol.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nevada at Las Vegas, Las Vegas, Nevada, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strawberries

Dietary Supplement

Freeze-dried strawberry powder

Control powder

Other

Control powder matched for fiber and strawberries

Primary outcomes

  1. Serum Lipid profiles

    Time frame: 14 weeks

    Serum LDL, total and HDL cholesterol, triglycerides

  2. Glycemic control

    Time frame: 14 weeks

    Blood glucose

  3. Serum lipid particle concentrations

    Time frame: 14 weeks

    Molar concentrations of serum lipids and particle size

  4. Diabetes control

    Time frame: 14 weeks

    Insulin resistance

Secondary outcomes

  1. Systemic Inflammation

    Time frame: 14 weeks

    Serum C-reactive protein and adipokines

  2. Systemic Anthocyanins

    Time frame: 14 weeks

    Strawberry anthocyanin metabolites measured in serum

  3. Serum metabolomics

    Time frame: 14 weeks

    primary and lipid metabolites in serum

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Collaborators

  • Oklahoma State University
  • University of Oklahoma

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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