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NCT Number: NCT02599740

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

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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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Research Organisation GmbH

Berlin, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natural fruit extract

Other

Natural fruit extract consumed with rice

Assumed active

Other

Assumed key active consumed with rice

Placebo

Other

Rice only

Primary outcomes

  1. Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments

    Time frame: 0-2 hours

    +iAUC

Secondary outcomes

  1. Change of 3-h PPG based on response to different treatments

    Time frame: 0-3 hours

    +iAUC

  2. Change of 2-h and 3-h post-prandial insulin based on response to different treatments

    Time frame: 0-2 hours and 0-3 hours

    tAUC

  3. Max plasma concentration for assumed key active

    Time frame: 0-12 hours

    Cmax

  4. Time of max plasma concentration for assumed key active

    Time frame: 0-12 hours

    Tmax

  5. AUC for plasma concentration versus time curve for assumed key active

    Time frame: 0-12 hours

    AUC

  6. Half-life of elimination phase for assumed key active

    Time frame: 0-12 hours

    t1/2

  7. Total amount of assumed key active excreted in urine

    Time frame: 0-36 hours

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 9, 2015
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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