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Clinical trial

Strawberries and Risk of Diabetes in Adults

ID
Name
UNLV-2021-252
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-12-31
Trial end
2024-06-30
Status
Recruiting
Phase
Early phase I
Treatment
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)
Arms:
Strawberry intervention
Other names:
Freeze-dried strawberries
Size
60
Primary endpoint
Glycemic control
12 weeks
Lipid control
12 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-12-01

1 organization

1 product

2 indications

Organization
University of Nevada, Las Vegas
Product
Freeze-dried strawberry powder
Indication
Pre-Diabetes
Indication
Metabolic Syndrome