Glin4: Assessment of the Glycemic Responses to Nutritional Products

NCT ID: NCT06797349

Last Updated: 2025-05-23

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

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2025-03-04

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

10 products will be tested (7 test products and 3 controls)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

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

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

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

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

Plant-Based Oat Beverage with Sugar 1 (containing 25 grams of carbohydrates)

Arm 5

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

Plant-Based Oat Beverage with Sugar 2 (containing 25 grams of carbohydrates)

Arm 6

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

Plant-Based Oat Beverage with Sugar 3 (containing 25 grams of carbohydrates)

Arm 7

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

Group Type OTHER

Fourth Concept product

Intervention Type DIETARY_SUPPLEMENT

Plant-Based Oat Beverage with Sugar 4 (containing 25 grams of carbohydrates)

Arm 8

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

Group Type OTHER

Fifth Concept product

Intervention Type DIETARY_SUPPLEMENT

Plant-Based Oat Beverage No Sugar 1(containing 25 grams of carbohydrates

Arm 9

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

Group Type OTHER

Sixth Concept product

Intervention Type DIETARY_SUPPLEMENT

Plant-Based Oat Beverage No Sugar 2 (containing 25 grams of carbohydrates

Arm 10

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

Group Type OTHER

Seventh Concept product

Intervention Type DIETARY_SUPPLEMENT

High calorie, high protein oral powder nutritional supplement. (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

Plant-Based Oat Beverage with Sugar 1 (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Second Concept product

Plant-Based Oat Beverage with Sugar 2 (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Third Concept product

Plant-Based Oat Beverage with Sugar 3 (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Fourth Concept product

Plant-Based Oat Beverage with Sugar 4 (containing 25 grams of carbohydrates)

Intervention Type DIETARY_SUPPLEMENT

Fifth Concept product

Plant-Based Oat Beverage No Sugar 1(containing 25 grams of carbohydrates

Intervention Type DIETARY_SUPPLEMENT

Sixth Concept product

Plant-Based Oat Beverage No Sugar 2 (containing 25 grams of carbohydrates

Intervention Type DIETARY_SUPPLEMENT

Seventh Concept product

High calorie, high protein oral powder nutritional supplement. (containing 25 grams of carbohydrates

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Baseline fasting Glucose ≥6.1 at screening visit
2. 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.
3. 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.
4. Major trauma or surgical event within 3 months of screening.
5. Known intolerance, sensitivity or allergy to test products.
6. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
7. 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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INQUIS Clinical Research

INDUSTRY

Sponsor Role collaborator

Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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INQUIS Clinical Research, Ltd , 20 Victoria Street, 3rd Floor

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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24REX0080350

Identifier Type: -

Identifier Source: org_study_id

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