The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy

NCT ID: NCT02388503

Last Updated: 2015-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-03-31

Brief Summary

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This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reference

No added fruit extract

Group Type PLACEBO_COMPARATOR

no added fruit extract

Intervention Type DIETARY_SUPPLEMENT

Active 1

lowest dose of fruit extract

Group Type ACTIVE_COMPARATOR

fruit extract

Intervention Type DIETARY_SUPPLEMENT

Active 2

low dose of fruit extract

Group Type ACTIVE_COMPARATOR

fruit extract

Intervention Type DIETARY_SUPPLEMENT

Active 3

medium dose of fruit extract

Group Type ACTIVE_COMPARATOR

fruit extract

Intervention Type DIETARY_SUPPLEMENT

Active 4

high dose of fruit extract

Group Type ACTIVE_COMPARATOR

fruit extract

Intervention Type DIETARY_SUPPLEMENT

Interventions

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no added fruit extract

Intervention Type DIETARY_SUPPLEMENT

fruit extract

Intervention Type DIETARY_SUPPLEMENT

fruit extract

Intervention Type DIETARY_SUPPLEMENT

fruit extract

Intervention Type DIETARY_SUPPLEMENT

fruit extract

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
* Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.

Exclusion Criteria

* Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
* Blood donation in the past 3 months and/or during the study.
* Reported intense sporting activities \> 10 h/week.
* Consumption of \> 14 units (female subjects) and \> 21 units (male subjects) alcoholic drinks in a typical week.
* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
* If female, is pregnant (or has been pregnant during the last \< 3 months) or will be planning pregnancy during the study period.
* If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
* Dislike, known allergy or intolerance to test products or other food products provided during the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Charité research organisation

Berlin, Charitéplatz 1, Germany

Site Status

Countries

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Germany

Other Identifiers

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FDS-NAA-1946

Identifier Type: -

Identifier Source: org_study_id

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