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Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance

Primary Purpose

Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilberry
Blackcurrant
Mango
Beetroot
Rose hip
Glucose drink
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postprandial Hyperglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Bilberry

    Blackcurrant

    Mango

    Beetroot

    Rose hip

    Glucose drink

    Arm Description

    A bilberry-based beverage with fermented oatmeal

    A blackcurrant-based beverage with fermented oatmeal

    A mango-based based beverage with fermented oatmeal

    A beetroot-based based beverage with fermented oatmeal

    A rose hip-based based beverage with fermented oatmeal

    A reference glucose drink

    Outcomes

    Primary Outcome Measures

    Efficacy of the study products on the postprandial serum insulin
    The postprandial incremental area under the curve for serum insulin

    Secondary Outcome Measures

    Efficacy of the study products on the postprandial serum glucose
    The postprandial incremental area under the curve for serum glucose

    Full Information

    First Posted
    May 17, 2017
    Last Updated
    May 18, 2017
    Sponsor
    Lund University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03159065
    Brief Title
    Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance
    Official Title
    Early Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    January 2015 (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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postprandial Hyperglycemia

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilberry
    Arm Type
    Experimental
    Arm Description
    A bilberry-based beverage with fermented oatmeal
    Arm Title
    Blackcurrant
    Arm Type
    Experimental
    Arm Description
    A blackcurrant-based beverage with fermented oatmeal
    Arm Title
    Mango
    Arm Type
    Experimental
    Arm Description
    A mango-based based beverage with fermented oatmeal
    Arm Title
    Beetroot
    Arm Type
    Experimental
    Arm Description
    A beetroot-based based beverage with fermented oatmeal
    Arm Title
    Rose hip
    Arm Type
    Experimental
    Arm Description
    A rose hip-based based beverage with fermented oatmeal
    Arm Title
    Glucose drink
    Arm Type
    Active Comparator
    Arm Description
    A reference glucose drink
    Intervention Type
    Other
    Intervention Name(s)
    Bilberry
    Intervention Description
    Fruit beverage with bilberry and fermented oatmeal
    Intervention Type
    Other
    Intervention Name(s)
    Blackcurrant
    Intervention Description
    Fruit beverage with blackcurrant and fermented oatmeal
    Intervention Type
    Other
    Intervention Name(s)
    Mango
    Intervention Description
    Fruit beverage with mango and fermented oatmeal
    Intervention Type
    Other
    Intervention Name(s)
    Beetroot
    Intervention Description
    Fruit beverage with beetroot and fermented oatmeal
    Intervention Type
    Other
    Intervention Name(s)
    Rose hip
    Intervention Description
    Fruit beverage with rose hip and fermented oatmeal
    Intervention Type
    Other
    Intervention Name(s)
    Glucose drink
    Intervention Description
    A reference glucose drink
    Primary Outcome Measure Information:
    Title
    Efficacy of the study products on the postprandial serum insulin
    Description
    The postprandial incremental area under the curve for 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
    Secondary Outcome Measure Information:
    Title
    Efficacy of the study products on the postprandial serum glucose
    Description
    The postprandial incremental area under the curve for 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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yvonne Granfeldt, Prof
    Organizational Affiliation
    Lund University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29486772
    Citation
    Xu J, Jonsson T, Plaza M, Hakansson A, Antonsson M, Ahren IL, Turner C, Spegel P, Granfeldt Y. Probiotic fruit beverages with different polyphenol profiles attenuated early insulin response. Nutr J. 2018 Feb 27;17(1):34. doi: 10.1186/s12937-018-0335-0.
    Results Reference
    derived

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    Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance

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