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

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ClinicalTrials.gov Identifier: NCT03185676
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Åsa Håkansson, Lund University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Bilberry Other: beverage without bilberries or probiotics Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Healthy adults with a BMI between 20-30

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185676


Locations
Sweden
Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder
Lund, Sweden
Sponsors and Collaborators
Lund University

Responsible Party: Åsa Håkansson, Associate Senior Lecturer, Lund University
ClinicalTrials.gov Identifier: NCT03185676     History of Changes
Other Study ID Numbers: InVeg (2)
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases