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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02388503

Enrollment

Registered

2015-03-17

Start date

2015-02-28

Completion date

2015-03-31

Last updated

2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Blood glucose

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTno added fruit extract

DIETARY_SUPPLEMENTfruit extract

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Positive incremental post-prandial blood glucose area under the curve	120 minutes

Secondary

Measure	Time frame
Post-prandial insulin response	120 minutes
AUC of fruit extract calculated by a non-compartmental model	180 minutes
AUC of fruit extract calculated by a population model	180 minutes
Positive incremental post-prandial blood glucose area under the curve	180 minutes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026