Back to resultsEfficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bilberry
beverage without bilberries or probiotics
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
Healthy adults with a BMI between 20-30
Exclusion Criteria:
-
Sites / Locations
- Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Billberry
Control
Arm Description
A bilberry-based probiotic beverage
A control beverage without bilberries or probiotics
Outcomes
Primary Outcome Measures
The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03185676
Brief Title
Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance
Official Title
The Long Term Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance as Compared to a Control.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Billberry
Arm Type
Experimental
Arm Description
A bilberry-based probiotic beverage
Arm Title
Control
Arm Type
Active Comparator
Arm Description
A control beverage without bilberries or probiotics
Intervention Type
Other
Intervention Name(s)
Bilberry
Intervention Description
A bilberry based probiotic beverage
Intervention Type
Other
Intervention Name(s)
beverage without bilberries or probiotics
Intervention Description
A control beverage without bilberries or probiotics
Primary Outcome Measure Information:
Title
The long term effect of a bilberry-based probiotic beverage on postprandial levels of serum insulin
Description
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)
Time Frame
Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy adults with a BMI between 20-30
Exclusion Criteria:
-
Facility Information:
Facility Name
Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder
City
Lund
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance
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