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Strawberries and Risk of Diabetes in Adults

Primary Purpose

PreDiabetes, Metabolic Syndrome

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Freeze-dried strawberry powder
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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%
  • 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.

Sites / Locations

  • University of Nevada at Las VegasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Strawberry intervention

Arm Description

Each participants on usual diet and lifestyle for 12 weeks

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

Outcomes

Primary Outcome Measures

Glycemic control
Blood glucose, insulin, glycated hemoglobin
Lipid control
Blood total and LDL cholesterol

Secondary Outcome Measures

Inflammation
cytokines C-reactive protein
Diabetes risk hormones
adiponectin, leptin

Full Information

First Posted
May 2, 2022
Last Updated
March 29, 2023
Sponsor
University of Nevada, Las Vegas
Collaborators
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05362968
Brief Title
Strawberries and Risk of Diabetes in Adults
Official Title
Strawberries and Risk of Diabetes in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Each participants on usual diet and lifestyle for 12 weeks
Arm Title
Strawberry intervention
Arm Type
Experimental
Arm Description
Each participants will consume freeze-dried strawberry powder (32g/day) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Freeze-dried strawberry powder
Other Intervention Name(s)
Freeze-dried strawberries
Intervention Description
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)
Primary Outcome Measure Information:
Title
Glycemic control
Description
Blood glucose, insulin, glycated hemoglobin
Time Frame
12 weeks
Title
Lipid control
Description
Blood total and LDL cholesterol
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Inflammation
Description
cytokines C-reactive protein
Time Frame
12 weeks
Title
Diabetes risk hormones
Description
adiponectin, leptin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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% 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arpita Basu
Phone
4056122414
Email
arpita.basu@unlv.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica De Jesus
Phone
7028950318
Email
jessica.dejesus@unlv.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arpita Basu, PhD
Organizational Affiliation
University of Nevada at Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada at Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arpita Basu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Strawberries and Risk of Diabetes in Adults

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