Assessment of the Glycemic Responses to Nutritional Products (GLIN#1)

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 (dextrose, containing 25 g of carbohydrates); Dietary supplement: Second Reference product (dextrose, containing 25 g of carbohydrates); Dietary supplement: Third Reference product (dextrose, containing 25 g of carbohydrates); Dietary supplement: High protein tube feed; Dietary supplement: High-protein tube feed with additional amino acid; Dietary supplement: Oral Nutritional Supplement for diabetes patients; Dietary supplement: Oral Nutritional Supplement for diabetes patients (new formula); Dietary supplement: ONS for disease related malnutrition; Dietary supplement: Plantbased ONS for disease related malnutrition

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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

9

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 g of carbohydrates); Reference dextrose solution containing 25 g of available 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 g of carbohydrates); Reference dextrose solution containing 25 g of available 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 g of carbohydrates); Reference dextrose solution containing 25 g of available carbohydrates
Other: Arm 4; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: High protein tube feed; Nutritional product containing 25 g of available carbohydrates
Other: Arm 5; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: High-protein tube feed with additional amino acid; Nutritional product containing 25 g of available carbohydrates
Other: Arm 6; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Oral Nutritional Supplement for diabetes patients; Nutritional product containing 25 g of available carbohydrates
Other: Arm 7; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Oral Nutritional Supplement for diabetes patients (new formula); Nutritional product containing 25 g of available carbohydrates
Other: Arm 8; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: ONS for disease related malnutrition; Nutritional product containing 25 g of available carbohydrates
Other: Arm 9; All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Plantbased ONS for disease related malnutrition; Nutritional product containing 25 g of available carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The glycemic index of nutritional products	9 test days (test days will be separated by at least 1 day in between tests for each participant)

Secondary Outcome Measures

Outcome Measure	Time Frame
The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references	9 test days (test days will be separated by at least 1 day in between tests for each participant)
The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references	9 test days (test days will be separated by at least 1 day in between tests for each participant)

Collaborators and Investigators

• Sponsor: Nutricia Research
• Collaborators: INQUIS Clinical Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Glycemic index; Healthy individuals; Glycemic response; Nutritional products
• Other Study ID Numbers: INQ-2137

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