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

Not Applicable

• Conditions: Glycemic Response
• Interventions: Dietary Supplement: First Reference product; Dietary Supplement: Second Concept product; Dietary Supplement: Third Concept product; Dietary Supplement: First Concept product; Dietary Supplement: Second Reference product; Dietary Supplement: Third Reference product

• Registration Number: NCT05308147
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-11
• Study Start: 2022-03-17
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1 (Reference)	First Reference product	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 5 (Concept)	Second Concept product	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 6 (Concept)	Third Concept product	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 4 (Concept)	First Concept product	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 2 (Reference)	Second Reference product	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 3 (Reference)	Third Reference product	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Primary Outcome Measures

Name	Time	Method
The glycemic index of nutritional products	3 months

Secondary Outcome Measures

Name	Time	Method
The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references	3 months
The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references	3 months

Trial Locations

Locations (1)

INQUIS Clinical Research, Ltd; 🇨🇦 Toronto, Ontario, Canada