Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

June 16, 2016 updated by: Danisco

Randomised, Single-blinded, Controlled, Crossover and Acute Clinical Intervention to Assess the Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products 1 and 2 are digested using glycaemic and insulinaemic response as markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DuPont Experimental Dietary Fibre products 1 and 2 glycaemic and insulinaemic response will be compared against that of polydextrose and dextrose when given to adult healthy volunteers.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leatherhead, United Kingdom, KT22 7RY
        • Leatherhead Food Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 18-27 kg/m2.
  • Self-diagnosed as healthy at the time of recruitment, confirmed by medical questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders.
  • No blood donations during the study.
  • Reported intense sporting activities < 10hr/w.
  • Reported alcohol consumption ≤21 units/w (female volunteers) or ≤28 units/w (male volunteers).
  • Feasibility to give blood sample as per study protocol.
  • Informed consent signed

Exclusion Criteria:

  • Dislike, allergy or intolerance to test products.
  • Fasting blood glucose levels <4.4 or >6.1.
  • Volunteer has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator.
  • Volunteer with history of diabetes and high blood pressure.
  • Having consumed anything apart from plain water in the twelve hours prior to the first test day.
  • Volunteer and/or immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization.
  • Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study.
  • Reported participation in another biomedical trial 1 month before the start of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Dietary Fibre 1
Dietary supplement: Experimental Dietary Fibre 1
22.17 g of product diluted in 250 ml of water taken once orally.
Experimental: Experimental Dietary Fibre 2
Dietary supplement: Experimental Dietary Fibre 2
21.84 g of product diluted in 250 ml of water taken once orally.
Active Comparator: Polydextrose
Dietary supplement: Polydextrose
21.48 g of product diluted in 250 ml of water taken once orally.
Active Comparator: Dextrose control
Dietary supplement: Dextrose
23.89 g of dextrose diluted in 250 ml of water taken once orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response
Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 111031-DP-2015-06-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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