Assessment of the Glycemic Responses to Nutritional Products (v2.0)

NCT ID: NCT05308147

Last Updated: 2022-04-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2022-05-31

Brief Summary

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This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.

Detailed Description

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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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Arm 1 (Reference)

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type OTHER

First Reference product

Intervention Type DIETARY_SUPPLEMENT

Dextrose (containing 25 grams of carbohydrates)

Arm 2 (Reference)

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type OTHER

Second Reference product

Intervention Type DIETARY_SUPPLEMENT

Dextrose (containing 25 grams of carbohydrates)

Arm 3 (Reference)

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type OTHER

Third Reference product

Intervention Type DIETARY_SUPPLEMENT

Dextrose (containing 25 grams of carbohydrates)

Arm 4 (Concept)

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type OTHER

First Concept product

Intervention Type DIETARY_SUPPLEMENT

Infant Formula (containing 25 grams of carbohydrates)

Arm 5 (Concept)

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type OTHER

Second Concept product

Intervention Type DIETARY_SUPPLEMENT

Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)

Arm 6 (Concept)

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type OTHER

Third Concept product

Intervention Type DIETARY_SUPPLEMENT

Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)

Interventions

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First Reference product

Dextrose (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Second Reference product

Dextrose (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Third Reference product

Dextrose (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

First Concept product

Infant Formula (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Second Concept product

Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Third Concept product

Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria

* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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INQUIS Clinical Research, Ltd

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Danone Nutricia Research

Role: CONTACT

+31 30 2095 000

Facility Contacts

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Janice Campbell

Role: primary

416-861-0506

Other Identifiers

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INQ-2137 v2.0

Identifier Type: -

Identifier Source: org_study_id

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