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Completed

NCT Number: NCT02388503

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

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.

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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

Berlin, Charitéplatz 1, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) ≥ 18.0 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.

Treatment and study plan

no added fruit extract

Dietary Supplement

fruit extract

Dietary Supplement

Primary outcomes

  1. Positive incremental post-prandial blood glucose area under the curve

    Time frame: 120 minutes

Secondary outcomes

  1. Post-prandial insulin response

    Time frame: 120 minutes

  2. Post-prandial insulin response

    Time frame: 180 minutes

  3. AUC of fruit extract calculated by a non-compartmental model

    Time frame: 180 minutes

  4. AUC of fruit extract calculated by a population model

    Time frame: 180 minutes

  5. Positive incremental post-prandial blood glucose area under the curve

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
May 1, 2015

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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