Glin4: Assessment of the Glycemic Responses to Nutritional Products (GLIN4)

Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Dietary supplement: First Reference product; Dietary supplement: Second reference product; Dietary supplement: Third reference product; Dietary supplement: First Concept product; Dietary supplement: Second Concept product; Dietary supplement: Third Concept product; Dietary supplement: Fourth Concept product; Dietary supplement: Fifth Concept product; Dietary supplement: Sixth Concept product; Dietary supplement: Seventh Concept product

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • INQUIS Clinical Research, Ltd , 20 Victoria Street, 3rd Floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: First Reference product; dextrose (containing 25 grams of carbohydrates)
Other: Arm 2; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Second reference product; dextrose (containing 25 grams of carbohydrates)
Other: Arm 3; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Third reference product; dextrose (containing 25 grams of carbohydrates)
Other: Arm 4; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: First Concept product; Plant-Based Oat Beverage with Sugar 1 (containing 25 grams of carbohydrates)
Other: Arm 5; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Second Concept product; Plant-Based Oat Beverage with Sugar 2 (containing 25 grams of carbohydrates)
Other: Arm 6; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Third Concept product; Plant-Based Oat Beverage with Sugar 3 (containing 25 grams of carbohydrates)
Other: Arm 7; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Fourth Concept product; Plant-Based Oat Beverage with Sugar 4 (containing 25 grams of carbohydrates)
Other: Arm 8; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Fifth Concept product; Plant-Based Oat Beverage No Sugar 1(containing 25 grams of carbohydrates
Other: Arm 9; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Sixth Concept product; Plant-Based Oat Beverage No Sugar 2 (containing 25 grams of carbohydrates
Other: Arm 10; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Seventh Concept product; High calorie, high protein oral powder nutritional supplement. (containing 25 grams of carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The glycemic index of nutritional products	from enrollment to the end of treatment at about 9 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nutricia Research
• Collaborators: INQUIS Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Actual): March 4, 2025
• Study Completion (Actual): March 4, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Glycemic Index; Glycemic response; Healthy Individuals; Nutritional products
• Other Study ID Numbers: 24REX0080350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No