- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03159065
Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance
May 18, 2017 updated by: Åsa Håkansson, Lund University
Early Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance in Healthy Adults
Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and insulin responses and hence promote well-being.
It has previously been observed that consumption of a bilberry drink decreases the postprandial insulin demand.
In the present study, the impact of probiotic fruit beverages with different polyphenol profiles on the postprandial levels of glucose and insulin, were investigated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, not on medication, non-allergic, individuals aged 18-65 years old, having a BMI between 20-30 kg/m2 and also maintaining stable body weight, i.e. less than 5% weight change in the last three months before the study.
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: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Bilberry
A bilberry-based beverage with fermented oatmeal
|
Fruit beverage with bilberry and fermented oatmeal
|
|
EXPERIMENTAL: Blackcurrant
A blackcurrant-based beverage with fermented oatmeal
|
Fruit beverage with blackcurrant and fermented oatmeal
|
|
EXPERIMENTAL: Mango
A mango-based based beverage with fermented oatmeal
|
Fruit beverage with mango and fermented oatmeal
|
|
EXPERIMENTAL: Beetroot
A beetroot-based based beverage with fermented oatmeal
|
Fruit beverage with beetroot and fermented oatmeal
|
|
EXPERIMENTAL: Rose hip
A rose hip-based based beverage with fermented oatmeal
|
Fruit beverage with rose hip and fermented oatmeal
|
|
ACTIVE_COMPARATOR: Glucose drink
A reference glucose drink
|
A reference glucose drink
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of the study products on the postprandial 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 postprandial incremental area under the curve for serum insulin
|
Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of the study products on the postprandial serum glucose
Time Frame: Incremental area under the curve for serum glucose from 0 min up to 120 min following the ingestion of the study product
|
The postprandial incremental area under the curve for serum glucose
|
Incremental area under the curve for serum glucose 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
Investigators
- Study Director: Yvonne Granfeldt, Prof, Lund University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 1, 2014
Primary Completion (ACTUAL)
November 1, 2014
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
May 17, 2017
First Submitted That Met QC Criteria
May 17, 2017
First Posted (ACTUAL)
May 18, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 19, 2017
Last Update Submitted That Met QC Criteria
May 18, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InVeg (1)
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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