The Effect of Wild Blueberry Consumption on Glucose Regulation in Healthy Adults

June 19, 2017 updated by: Kim Stote, University of Prince Edward Island

The Effect of Wild Blueberry Consumption on Diabetes: Evaluation of Glucose Regulation, Gastrointestinal Hormones and Satiety in Healthy Adults

The objective of the study is to determine how wild blueberry consumption affects glucose regulation, gastrointestinal hormones and satiety in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy men and women (ages 21 - 65 years) were recruited to take part in a randomized, placebo controlled crossover design study. Subjects were screened to determine their health status (e.g. height, weight, body mass index, blood pressure and medical history). Subjects were randomly assigned to a sequence of two treatments with two study periods. The treatments are frozen wild blueberries and a placebo developed to match calories and fiber of the frozen wild blueberries. The subjects were asked to avoid high polyphenol foods in their typical diet for 7 days and consume one of the two treatments as a dietary intervention. After the seventh day subjects consumed a test meal along with either the wild blueberry or placebo. Blood was collected to determine glucose and satiety hormone levels.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 4P3
        • University of Prince Edward Island, Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female

Exclusion Criteria:

  • BMI < 20 and > 30 kg/m²
  • Pregnant women or women who plan on becoming pregnant during the study
  • Postpartum women
  • Lactating women
  • Diabetes Mellitus
  • Kidney disease
  • Liver disease
  • GI Disease
  • Certain cancers
  • Smokers
  • Blueberry allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo control
Other: Placebo
Placebo - matched for calories and fiber
Experimental: Blueberry
150 grams wild blueberries
Other: Blueberry
Blueberry - 150 grams wild blueberries (whole fruit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose (mmol/L)
Time Frame: Change from baseline 0 hours and 2 hours
Plasma glucose
Change from baseline 0 hours and 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Prince Edward Island

Investigators

  • Principal Investigator: Katherine Gottschall-Pass, PhD, University of Prince Edward Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

June 2, 2017

Study Completion (Actual)

June 2, 2017

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • UPEI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be shared as requested by other researchers. It may be made available by June 2018.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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