NCT03185676

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

June 12, 2017

Last Update Submit

February 7, 2018

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Study Arms (2)

Billberry

EXPERIMENTAL

A bilberry-based probiotic beverage

Other: Bilberry

Control

ACTIVE COMPARATOR

A control beverage without bilberries or probiotics

Other: beverage without bilberries or probiotics

Interventions

BilberryOTHER

A bilberry based probiotic beverage

Billberry
beverage without bilberries or probioticsOTHER

A control beverage without bilberries or probiotics

Control

Eligibility Criteria

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

You may qualify if:

  • Healthy adults with a BMI between 20-30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinisk Prövningsenhet, Kliniska Studier Sverige - Forum Söder

Lund, Sweden

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Vaccinium myrtillus extractBeveragesProbiotics

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary SupplementsFood

Study Design

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

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 14, 2017

Study Start

May 2, 2017

Primary Completion

July 15, 2017

Study Completion

November 30, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)