- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396262
Effect of Processed Blueberry on Blood Glucose and Antioxidant Status in Human Adults
March 17, 2023 updated by: Mount Saint Vincent University
Effect of Hydro-Thermodynamic (HTD) Processed Blueberries on Postprandial Blood Glucose Control and Antioxidant Status in Human Adults
Canada's Food Guide (2007) recommended 7-10 servings of fruits and vegetables per day for a normal adult population.
Although fruit juice (125 ml) is considered as one serving of fruits, the consumption of some fruit juices may be limited due to their high amount of sugar.
The consumption of sugary drinks can lead to a rapid rise in postprandial glycaemia.
Wild blueberries, due to their high level of anthocyanins, may provide multiple health benefits including improved blood glucose control, however, the consumption of fresh berries is limited by their short seasonal availability.
Hydro-Thermodynamic (HTD) processing of blueberries allows the processing of whole berries including their skin and seeds into a beverage with the amount of anthocyanins comparable with fresh berries.
The objective of the study is to investigate the effect of HTD-processed blueberries on postprandial glycaemia and antioxidant activity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
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
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3M 2J6
- Mount Saint Vincent University
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults
- Body mass index (BMI) within normal range (18.5-24.9 kg/m2 for adults)
Exclusion Criteria:
- Chronic metabolic diseases or inflammatory conditions
- Smokers
- A medication that influences glucose control or gastrointestinal function
- Known allergies
- Intellectual disabilities
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HTD-blueberry beverage with white bread
The beverage prepared using hydro-thermodynamic processing of whole wild blueberries.
|
HTD-blueberry beverage with white bread.
|
Experimental: Sweetened water (control) with white bread
The water control of the same volume and with the same amount of available carbohydrate as HTD-blueberry beverage.
|
Sweetened water with white bread as a control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose
Time Frame: 0-120 min
|
The concentration of glucose in venous blood after consuming HTD-blueberry beverage with white bread or water control with white bread.
|
0-120 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial antioxidant activity in blood
Time Frame: 0-120 min
|
The total antioxidant activity in blood plasma determined using a commercial Antioxidant Assay Kit.
|
0-120 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bohdan Luhovyy, PhD, Mount Saint Vincent University
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)
November 1, 2015
Primary Completion (Actual)
August 31, 2016
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 17, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2019-204
- 2015-102 (Other Identifier: Mount Saint Vincent University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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