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


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This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kim Stote, University of Prince Edward Island

ClinicalTrials.gov Identifier:

NCT03192605

First received: June 16, 2017

Last updated: June 19, 2017

Last verified: June 2017

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

Diabetes Other: Blueberry Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: The Effect of Wild Blueberry Consumption on Diabetes: Evaluation of Glucose Regulation, Gastrointestinal Hormones and Satiety in Healthy Adults

Primary Outcome Measures:

  • Glucose (mmol/L) [ Time Frame: Change from baseline 0 hours and 2 hours ]

    Plasma glucose

Enrollment: 17
Actual Study Start Date: May 15, 2017
Study Completion Date: June 2, 2017
Primary Completion Date: June 2, 2017 (Final data collection date for primary outcome measure)
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

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.

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03192605

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

University of Prince Edward Island

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

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
Study First Received: June 16, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data will be shared as requested by other researchers. It may be made available by June 2018.

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

ClinicalTrials.gov processed this record on June 20, 2017