NCT03192605

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

18 days

First QC Date

June 16, 2017

Last Update Submit

June 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose (mmol/L)

    Plasma glucose

    Change from baseline 0 hours and 2 hours

Study Arms (2)

Blueberry

EXPERIMENTAL

150 grams wild blueberries

Other: Blueberry

Placebo

PLACEBO COMPARATOR

Placebo control

Other: Placebo

Interventions

Blueberry - 150 grams wild blueberries (whole fruit)

Blueberry
PlaceboOTHER

Placebo - matched for calories and fiber

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Prince Edward Island, Health Sciences

Charlottetown, Prince Edward Island, C1A 4P3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Katherine Gottschall-Pass, PhD

    University of Prince Edward Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Chair of Nutrisciences and Health

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

May 15, 2017

Primary Completion

June 2, 2017

Study Completion

June 2, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

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

Locations