Skip to main content
OpenTrials
Completed

NCT Number: NCT05362968

Strawberries and Risk of Diabetes in Adults

Strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. Recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation, keeping in view the huge public health burden of diabetes in the US. In this study, the investigators propose to investigate the effects of a dietary achievable dose of strawberries on glycemic control, insulin resistance, and HbA1c (primary variables) and biomarkers of inflammation and endothelial function in a 28- week controlled crossover study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Nevada at Las Vegas

Las Vegas, Nevada, 89154, United States

About this study

Strawberries are popularly consumed fruits in the US and are a rich source of several bioactive compounds with demonstrated health benefits in T2D and cardiovascular disease (CVD). Based on previously reported studies, strawberries have been shown to improve elevated lipid profiles/dyslipidemia, oxidative stress and inflammation in adults with the metabolic syndrome or prediabetes. In a recently reported study, strawberries at a dose of two-and-a-half servings per day for four weeks was shown to significantly reduce insulin resistance and serum adipokines in obese adults. These results conform to only a few reported trials using strawberries in adults with cardiometabolic risks. While these study findings are clinically meaningful, these warrant urgent investigation in trials of longer duration specifically targeting adults with impaired fasting glucose (vs. other features of the metabolic syndrome) as well as adults with diagnosed T2D with poor glycemic control despite taking medications. Furthermore, to the best of our knowledge, only one clinical trial has been reported on the role of strawberries in improving glycemic control, oxidative stress, and inflammation in adults with T2D. While these results are encouraging, they lack generalizability due to the short duration of the study (six weeks) that precludes accurate changes in glycated hemoglobin (HbA1c) as a stable biomarker of glucose control. Based on these gaps in the existing literature, the investigators will examine the effects of strawberry supplementation at a dose of 2.5 servings/day for 12 weeks on glycemic control and related cardiometabolic profiles in prediabetes in a randomized controlled crossover trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 18 years of age
  • Waist size greater than 40 inches in men or 35 inches in women
  • Blood glucose greater than 100mg/dL but less than 126 mg/dL or glycated hemoglobin less than 6.5%
  • Insulin resistance >1.0
  • Not on diabetes medications
  • Normal liver and kidney function tests

Exclusion criteria

  • Allergy to strawberries
  • Smoke or drink alcohol on a regular basis
  • Pregnant or lactating

Treatment and study plan

Freeze-dried strawberry powder

Drug

Whole strawberries are freeze-dried to form a powder with improved shelf life that will be used in this research study. Strawberry powder will be provided by the California Strawberry Commission (Watsonville, CA)

Other names: Freeze-dried strawberries

Primary outcomes

  1. Glycemic control

    Time frame: 12 weeks

    Blood glucose, insulin, glycated hemoglobin

  2. Lipid control

    Time frame: 12 weeks

    Blood total and LDL cholesterol

Secondary outcomes

  1. Inflammation

    Time frame: 12 weeks

    cytokines C-reactive protein adhesion molecules

  2. Diabetes risk hormones

    Time frame: 12 weeks

    adiponectin, leptin

  3. Oxidative stress

    Time frame: 12 weeks

    Serum measures of antioxidants

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Collaborators

  • University of Oklahoma

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 5, 2022
Registry last updated
May 18, 2025

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.

Published trials that share one or more normalized conditions with this study.