Blood Glucose Response of Processed Starch

NCT ID: NCT06048978

Last Updated: 2025-05-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2023-11-30

Brief Summary

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The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.

Detailed Description

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Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.

Conditions

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Glycemic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Native Starch, then Processed Starch

Participants will first receive the Commercial Native Starch in a fasting state in one clinical visit. After a washout of \>24 hours, the participants will then receive the Extrusion Processed Starch in a fasting state in one clinical visit.

Group Type EXPERIMENTAL

Commercial native starch without processing

Intervention Type OTHER

A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.

Modified starch with extrusion processing

Intervention Type OTHER

A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.

Processed Starch, then Native Starch

Participants will first receive the Extrusion Processed Starch in a fasting state in one clinical visit. After a washout of \>24 hours, the participants then will receive the Commercial Native Starch in a fasting state in one clinical visit.

Group Type EXPERIMENTAL

Commercial native starch without processing

Intervention Type OTHER

A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.

Modified starch with extrusion processing

Intervention Type OTHER

A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.

Interventions

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Commercial native starch without processing

A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.

Intervention Type OTHER

Modified starch with extrusion processing

A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult males or non-pregnant females.
* eligible to receive income in Canada.

Exclusion Criteria

* age less than 18 years
* any known food allergies or intolerances to the investigational product
* medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
* known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions
* any major medical or surgical events requiring hospitalization within the preceding 3 months
* the presence of disease or drug(s) which influence digestion and absorption of nutrients
* the short-term use of systemic steroids or atypical antipsychotics (\<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution)
* any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results
* any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role collaborator

INQUIS Clinical Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas MS Wolever, MD, PhD, DM (Oxon)

Role: PRINCIPAL_INVESTIGATOR

INQUIS Clinical Research

Locations

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INQUIS Clinical Research Ltd.

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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INQ-2330

Identifier Type: -

Identifier Source: org_study_id

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