Strawberries and Risk of Diabetes in Adults

Metabolic Syndrome Clinical Trial

Official title:

Strawberries and Risk of Diabetes in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362968
• Other study ID #: UNLV-2021-252
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2023
• Est. completion date: June 3, 2024

Study information

• Verified date: June 2024
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 3, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• PreDiabetes

Intervention

Drug:
• Freeze-dried strawberry powder
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)

Locations

Country	Name	City	State
United States	University of Nevada at Las Vegas	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Blood glucose, insulin, glycated hemoglobin	12 weeks
Primary	Lipid control	Blood total and LDL cholesterol	12 weeks
Secondary	Inflammation	cytokines C-reactive protein	12 weeks
Secondary	Diabetes risk hormones	adiponectin, leptin	12 weeks