Blood Glucose and Insulin Responses to Snack Food Products

January 30, 2019 updated by: Mondelēz International, Inc.

A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food

The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6BZ
        • Reading Scientific Services Limited

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female (not less than 40% males or females
  • Non-smoker
  • Aged 18 to 55 years
  • Have a body mass index between 18.5 to 29.99 kg/m2
  • Fasting blood glucose (finger-stick) >3.3 and <5.6 mmol/L (Visit 2)
  • Two-hour OGTT glucose (finger-stick) <7.8 mmol/L (Visit 2)
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
  • Any significant concurrent illness
  • History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
  • Have assessed an investigational product for GI in the last 72 hours.
  • Concurrent participation in any other safety study
  • History of diabetes, hepatitis, AIDS, anaemia or a heart condition
  • The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.
  • Had any type of gastrointestinal surgery, including gastric bypass
  • Having consumed anything apart from plain water in the 12 hours prior to each test
  • Have been medically diagnosed as having high blood pressure or heart disease

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Test Food
Snack base
Other: Dietary Intervention
Experimental: Experimental Test Food 1
Snack Base containing ingredient 1
Other: Dietary Intervention
Experimental: Experimental Test Food 2
Snack base containing ingredient 2
Other: Dietary Intervention
Experimental: Experimental Test Food 3
Snack base containing ingredients 1 and 2
Other: Dietary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycaemic index of experimental test foods compared to that of control test food using venous plasma.
Time Frame: 0-120 minutes
0-120 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycaemic index of experimental test foods compared to that of control test food using capillary blood
Time Frame: 0-120 minutes
0-120 minutes
Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood
Time Frame: 0-180 minutes
0-180 minutes
Measure insulin in venous plasma
Time Frame: 0-180 minutes
0-180 minutes
Measure C-peptide in venous plasma
Time Frame: 0-180 minutes
0-180 minutes

Collaborators and Investigators

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

Sponsor

Mondelēz International, Inc.

Collaborators

Reading Scientific Services Ltd.

Investigators

  • Study Director: Valerie Hart, SCS, Dip, MICR, Reading Scientific Services Limited
  • Principal Investigator: Dr. Suzana Louth, Reading Scientific Services Limited

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

April 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

April 22, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 26, 2011

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • P10-08857 version 01

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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