Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-12-31

Brief Summary

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This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

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Detailed Description

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The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.

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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Placebo

Rice only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Rice only

Assumed active

Assumed key active consumed with rice

Group Type ACTIVE_COMPARATOR

Assumed active

Intervention Type OTHER

Assumed key active consumed with rice

Natural fruit extract

Natural fruit extract consumed with rice

Group Type ACTIVE_COMPARATOR

Natural fruit extract

Intervention Type OTHER

Natural fruit extract consumed with rice

Interventions

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Natural fruit extract

Natural fruit extract consumed with rice

Intervention Type OTHER

Assumed active

Assumed key active consumed with rice

Intervention Type OTHER

Placebo

Rice only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery \[with exception of cholecystectomy and appendectomy\] and inflammatory diseases).
* Fasting blood glucose value of subjects is ≥ 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 within 14 days before day 1 except for both paracetamol and hormonal contraception.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes