Blood Glucose and Insulin Responses to Snack Food Products

NCT ID: NCT01341769

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Study Focus 1:Glycaemic Index Study Focus 2:Glycaemic Response Study Focus 3:Insulinemic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Test Food

Snack base

Group Type PLACEBO_COMPARATOR

Dietary Intervention

Intervention Type OTHER

Experimental Test Food 1

Snack Base containing ingredient 1

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Experimental Test Food 2

Snack base containing ingredient 2

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Experimental Test Food 3

Snack base containing ingredients 1 and 2

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Interventions

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Dietary Intervention

Intervention Type OTHER

Dietary Intervention

Intervention Type OTHER

Dietary Intervention

Intervention Type OTHER

Dietary Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reading Scientific Services Ltd.

INDUSTRY

Sponsor Role collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Kraft Foods, Inc

Principal Investigators

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Valerie Hart, SCS, Dip, MICR

Role: STUDY_DIRECTOR

Reading Scientific Services Limited

Dr. Suzana Louth

Role: PRINCIPAL_INVESTIGATOR

Reading Scientific Services Limited

Locations

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Reading Scientific Services Limited

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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P10-08857 version 01

Identifier Type: -

Identifier Source: org_study_id

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