NCT03159065

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 17, 2017

Last Update Submit

May 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the study products on the postprandial serum insulin

    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 Outcomes (1)

  • Efficacy of the study products on the postprandial serum glucose

    Incremental area under the curve for serum glucose from 0 min up to 120 min following the ingestion of the study product

Study Arms (6)

Bilberry

EXPERIMENTAL

A bilberry-based beverage with fermented oatmeal

Other: Bilberry

Blackcurrant

EXPERIMENTAL

A blackcurrant-based beverage with fermented oatmeal

Other: Blackcurrant

Mango

EXPERIMENTAL

A mango-based based beverage with fermented oatmeal

Other: Mango

Beetroot

EXPERIMENTAL

A beetroot-based based beverage with fermented oatmeal

Other: Beetroot

Rose hip

EXPERIMENTAL

A rose hip-based based beverage with fermented oatmeal

Other: Rose hip

Glucose drink

ACTIVE COMPARATOR

A reference glucose drink

Other: Glucose drink

Interventions

Fruit beverage with bilberry and fermented oatmeal

Bilberry

Fruit beverage with blackcurrant and fermented oatmeal

Blackcurrant
MangoOTHER

Fruit beverage with mango and fermented oatmeal

Mango

Fruit beverage with beetroot and fermented oatmeal

Beetroot

Fruit beverage with rose hip and fermented oatmeal

Rose hip

A reference glucose drink

Glucose drink

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hyperglycemia

Interventions

Vaccinium myrtillus extractMangifera indica extract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yvonne Granfeldt, Prof

    Lund University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Senior Lecturer

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 18, 2017

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share