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

NCT02388503 | Completed

• 1 other identifier: FDS-NAA-1946
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (1)

• Positive incremental post-prandial blood glucose area under the curve

  120 minutes

Secondary Outcomes (5)

• 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

Study Arms (5)

Reference

PLACEBO COMPARATOR

No added fruit extract

Dietary Supplement: no added fruit extract

Active 1

ACTIVE COMPARATOR

lowest dose of fruit extract

Dietary Supplement: fruit extract

Active 2

ACTIVE COMPARATOR

low dose of fruit extract

Dietary Supplement: fruit extract

Active 3

ACTIVE COMPARATOR

medium dose of fruit extract

Dietary Supplement: fruit extract

Active 4

ACTIVE COMPARATOR

high dose of fruit extract

Dietary Supplement: fruit extract

Interventions

no added fruit extract DIETARY_SUPPLEMENT

Reference

fruit extract DIETARY_SUPPLEMENT

Active 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

Charité research organisation

Berlin, Charitéplatz 1, 10117, Germany

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 17, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

DE (1)