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

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ClinicalTrials.gov Identifier: NCT03192605
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Kim Stote, University of Prince Edward Island

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

Condition or disease Intervention/treatment Phase
Diabetes Other: Blueberry Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Wild Blueberry Consumption on Diabetes: Evaluation of Glucose Regulation, Gastrointestinal Hormones and Satiety in Healthy Adults
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blueberry
150 grams wild blueberries
Other: Blueberry
Blueberry - 150 grams wild blueberries (whole fruit)

Placebo Comparator: Placebo
Placebo control
Other: Placebo
Placebo - matched for calories and fiber




Primary Outcome Measures :
  1. Glucose (mmol/L) [ Time Frame: Change from baseline 0 hours and 2 hours ]
    Plasma glucose



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192605


Locations
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Canada, Prince Edward Island
University of Prince Edward Island, Health Sciences
Charlottetown, Prince Edward Island, Canada, C1A 4P3
Sponsors and Collaborators
University of Prince Edward Island
Investigators
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Principal Investigator: Katherine Gottschall-Pass, PhD University of Prince Edward Island

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Responsible Party: Kim Stote, Research Chair of Nutrisciences and Health, University of Prince Edward Island
ClinicalTrials.gov Identifier: NCT03192605     History of Changes
Other Study ID Numbers: UPEI
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared as requested by other researchers. It may be made available by June 2018.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No