Glin4: Assessment of the Glycemic Responses to Nutritional Products

NCT06797349 | Completed Phase 4

• 1 other identifier: 24REX0080350
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glycemic Response

Keywords

Glycemic response; Glycemic Index; Nutritional products; Healthy Individuals

Outcome Measures

Primary Outcomes (1)

• The glycemic index of nutritional products

  from enrollment to the end of treatment at about 9 weeks

Secondary Outcomes (2)

• 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references

  from enrollment to the end of treatment at about 9 weeks

• 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references

  from enrollment to the end of treatment at about 9 weeks

Study Arms (10)

Arm 1

OTHER

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

Dietary Supplement: First Reference product

Arm 2

OTHER

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

Dietary Supplement: Second reference product

Arm 3

OTHER

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

Dietary Supplement: Third reference product

Arm 4

OTHER

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

Dietary Supplement: First Concept product

Arm 5

OTHER

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

Dietary Supplement: Second Concept product

Arm 6

OTHER

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

Dietary Supplement: Third Concept product

Arm 7

OTHER

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

Dietary Supplement: Fourth Concept product

Arm 8

OTHER

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

Dietary Supplement: Fifth Concept product

Arm 9

OTHER

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

Dietary Supplement: Sixth Concept product

Arm 10

OTHER

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

Dietary Supplement: Seventh Concept product

Interventions

First Reference product DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

Arm 1

Second reference product DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

Arm 2

Third reference product DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

Arm 3

First Concept product DIETARY_SUPPLEMENT

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

Arm 4

Second Concept product DIETARY_SUPPLEMENT

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

Arm 5

Third Concept product DIETARY_SUPPLEMENT

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

Arm 6

Fourth Concept product DIETARY_SUPPLEMENT

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

Arm 7

Fifth Concept product DIETARY_SUPPLEMENT

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

Arm 8

Sixth Concept product DIETARY_SUPPLEMENT

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

Arm 9

Seventh Concept product DIETARY_SUPPLEMENT

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

Arm 10

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Baseline fasting Glucose ≥6.1 at screening visit
• 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.

Sponsors & Collaborators

• Nutricia Research: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

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

Toronto, Ontario, M5C 2N8, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 10 products will be tested (7 test products and 3 controls)

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: January 23, 2025
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)