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

This study is currently recruiting participants.
Verified June 2017 by Åsa Håkansson, Lund University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03185676
First Posted: June 14, 2017
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Åsa Håkansson, Lund University
  Purpose
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 Intervention
Insulin Resistance Other: Bilberry Other: beverage without bilberries or probiotics

Study Type: Interventional
Study Design: 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.

Further study details as provided by Åsa Håkansson, Lund University:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 32
Actual Study Start Date: May 2, 2017
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

  Contacts and Locations
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


Contacts
Contact: Yvonne Granfeldt, Prof +46-70 569 33 75 yvonne.granfeldt@food.lth.se

Locations
Sweden
Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder Recruiting
Lund, Sweden
Contact: Yvonne Granfeldt, Prof         
Sponsors and Collaborators
Lund University
  More Information

Responsible Party: Åsa Håkansson, Associate Senior Lecturer, Lund University
ClinicalTrials.gov Identifier: NCT03185676     History of Changes
Other Study ID Numbers: InVeg (2)
First Submitted: June 12, 2017
First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: June 2017
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