Strawberries and Risk of Diabetes in Adults

NCT05362968 | Completed Phase 1 FDA Drug

• 1 other identifier: UNLV-2021-252
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  Blood glucose, insulin, glycated hemoglobin

  12 weeks

• Lipid control

  Blood total and LDL cholesterol

  12 weeks

Secondary Outcomes (3)

• Inflammation

  12 weeks

• Diabetes risk hormones

  12 weeks

• Oxidative stress

  12 weeks

Study Arms (2)

Control arm

NO INTERVENTION

Each participants on usual diet and lifestyle for 12 weeks

Strawberry intervention

EXPERIMENTAL

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

Drug: Freeze-dried strawberry powder

Interventions

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)

Also known as: Freeze-dried strawberries

Strawberry intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• University of Oklahoma: collaborator

Study Sites (1)

University of Nevada at Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Prediabetic State; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Arpita Basu, PhD

  University of Nevada at Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: January 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 3, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)