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NCT05362968 | Recruiting | PreDiabetes


Strawberries and Risk of Diabetes in Adults
Sponsor:

University of Nevada, Las Vegas

Information provided by (Responsible Party):

Arpita Basu

Brief Summary:

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.

Condition or disease

PreDiabetes

Metabolic Syndrome

Intervention/treatment

Freeze-dried strawberry powder

Phase

Phase 1

Detailed Description:

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.

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Strawberries and Risk of Diabetes in Adults
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024
Arm Intervention/treatment

No Intervention: Control arm

Each participants on usual diet and lifestyle for 12 weeks

Experimental: Strawberry intervention

Each participants will consume freeze-dried strawberry powder (32g/day) for 12 weeks

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

Strawberries and Risk of Diabetes in Adults

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Strawberries and Risk of Diabetes in Adults

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Locations


Recruiting

United States, Nevada

University of Nevada at Las Vegas

Las Vegas, Nevada, United States, 89154

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