Assessment of the Glycemic Responses to Nutritional Products (v2.0) (GLIN#2)

Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals (v2.0)

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: Recruiting
• 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

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

Contacts and Locations

• Study Contact: Name: Danone Nutricia Research; Phone Number: +31 30 2095 000; Email: register.clinicalresearchnutricia@danone.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Recruiting
      • INQUIS Clinical Research, Ltd
      • Contact: Janice Campbell; Phone Number: 416-861-0506; Email: info@inquis.com
      • Principal Investigator: Thomas Wolever, BM BCh PhD DM (Oxon)

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1 (Reference); 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 (Reference); 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 (Reference); 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 (Concept); All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: First Concept product; Infant Formula (containing 25 grams of carbohydrates)
Other: Arm 5 (Concept); All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Second Concept product; Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)
Other: Arm 6 (Concept); All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.	Dietary supplement: Third Concept product; Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The glycemic index of nutritional products	3 months

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

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 31, 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 v2.0

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