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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: no added fruit extract; Dietary supplement: fruit extract

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Charitéplatz 1
    • Berlin, Charitéplatz 1, Germany, 10117
      • Charité Research Organisation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Positive incremental post-prandial blood glucose area under the curve	180 minutes
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

Collaborators and Investigators

• Sponsor: Unilever R&D

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Blood glucose
• Other Study ID Numbers: FDS-NAA-1946