Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance

February 7, 2018 updated by: Åsa Håkansson, Lund University

The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.

The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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

  • Sweden
      • Lund, Sweden
        • Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy adults with a BMI between 20-30

Exclusion Criteria:

-

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Billberry
A bilberry-based probiotic beverage
Other: Bilberry
A bilberry based probiotic beverage
ACTIVE_COMPARATOR: Control
A control beverage without bilberries or probiotics
Other: beverage without bilberries or probiotics
A control beverage without bilberries or probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin
Time Frame: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
The incremental area under the curve (AUC) will be measured for the levels of postprandial serum insuling from 0 min to 120 min following ingestion of the product (included intermediate measuring time points are 30, 60 and 90 min)
Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund 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)

May 2, 2017

Primary Completion (ACTUAL)

July 15, 2017

Study Completion (ACTUAL)

November 30, 2017

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (ACTUAL)

June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InVeg (2)

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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