NCT04396262

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

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

November 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

April 1, 2020

Last Update Submit

March 17, 2023

Conditions

Keywords

BlueberryBlood GlucoseAntioxidantsHydro-Thermodynamic ProcessingBeverages

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    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 Outcomes (1)

  • Postprandial antioxidant activity in blood

    0-120 min

Study Arms (2)

HTD-blueberry beverage with white bread

EXPERIMENTAL

The beverage prepared using hydro-thermodynamic processing of whole wild blueberries.

Other: Food-1

Sweetened water (control) with white bread

EXPERIMENTAL

The water control of the same volume and with the same amount of available carbohydrate as HTD-blueberry beverage.

Other: Food-2

Interventions

Food-1OTHER

HTD-blueberry beverage with white bread.

HTD-blueberry beverage with white bread
Food-2OTHER

Sweetened water with white bread as a control.

Sweetened water (control) with white bread

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults
  • Body mass index (BMI) within normal range (18.5-24.9 kg/m2 for adults)

You may not qualify if:

  • Chronic metabolic diseases or inflammatory conditions
  • Smokers
  • A medication that influences glucose control or gastrointestinal function
  • Known allergies
  • Intellectual disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

Study Officials

  • Bohdan Luhovyy, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

May 20, 2020

Study Start

November 1, 2015

Primary Completion

August 31, 2016

Study Completion

August 31, 2022

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations