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

Sponsor

Unilever R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT02388503

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

69.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: no added fruit extract Dietary Supplement: fruit extract Dietary Supplement: fruit extract Dietary Supplement: fruit extract Dietary Supplement: fruit extract	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Reference No added fruit extract	Dietary Supplement: no added fruit extract
Active Comparator: Active 1 lowest dose of fruit extract	Dietary Supplement: fruit extract
Active Comparator: Active 2 low dose of fruit extract	Dietary Supplement: fruit extract
Active Comparator: Active 3 medium dose of fruit extract	Dietary Supplement: fruit extract
Active Comparator: Active 4 high dose of fruit extract	Dietary Supplement: fruit extract

Outcome Measures

Primary Outcome Measures

Positive incremental post-prandial blood glucose area under the curve [120 minutes]

Secondary Outcome Measures

Post-prandial insulin response [120 minutes]
Post-prandial insulin response [180 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité research organisation	Berlin	Charitéplatz 1	Germany	10117

Sponsors and Collaborators

Unilever R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unilever R&D

ClinicalTrials.gov Identifier:

NCT02388503

Other Study ID Numbers:

FDS-NAA-1946

First Posted:

Mar 17, 2015

Last Update Posted:

May 1, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Unilever R&D

Blood glucose

Study Results

No Results Posted as of May 1, 2015