Glin3: Assessment of the Glycemic Responses to Nutritional Products (GLIN#3)

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 series 1; Dietary supplement: second reference product seies 1; Dietary supplement: third reference product series 1; Dietary supplement: first concept product series 1; Dietary supplement: second concept product series 1; Dietary supplement: third concept product series 1; Dietary supplement: 4th concept product seris 1; Dietary supplement: 5th concept product series 1; Dietary supplement: 6th concept product series 1; Dietary supplement: 1st reference product series 2; Dietary supplement: 2nd reference product series 2; Dietary supplement: 3rd reference product series 2; Dietary supplement: 1st concept product series 2; Dietary supplement: 2nd concept product series 2; Dietary supplement: 3rd concept product series 2; Dietary supplement: 4th concept product series 2; Dietary supplement: 5th concept product series 2; Dietary supplement: 6th concept product series 2

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada, M5C 2N8
    • INQUIS Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

18

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 series 1; 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 seies 1; 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 series 1; 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 series 1; Standard tube feed (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 series 1; Tube feed with added fibers (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 series 1; Tube feed with extra energy (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: 4th concept product seris 1; Tube feed with extra energy and added fibers (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: 5th concept product series 1; Plant based oral nutritional supplement for disease related malnutrition (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: 6th concept product series 1; Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (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: 1st reference product series 2; dextrose (containing 25 grams of carbohydrates)
Other: arm 11; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 2nd reference product series 2; dextrose (containing 25 grams of carbohydrates)
Other: arm 12; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 3rd reference product series 2; dextrose (containing 25 grams of carbohydrates)
Other: arm 13; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 1st concept product series 2; High energy plant based tube feed (containing 25 grams of carbohydrates)
Other: arm 14; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 2nd concept product series 2; High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)
Other: arm 15; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 3rd concept product series 2; High protein tube feed (containing 25 grams of carbohydrates)
Other: arm 16; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 4th concept product series 2; High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)
Other: arm 17; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 5th concept product series 2; Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)
Other: arm 18; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: 6th concept product series 2; Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The glycemic index of nutritional products	6 months

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	6 months
2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references	6 months

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Glycemic Index; Healthy individuals; Glycemic response; Nutritional products
• Other Study ID Numbers: 23REX0060928

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