Assessment of the Glycemic Responses to Nutritional Products

Not Applicable

Completed

• Conditions: Glycemic Response
• Interventions: 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: Second Reference product (dextrose, containing 25 g of carbohydrates); Dietary Supplement: ONS for disease related malnutrition; Dietary Supplement: Plantbased ONS for disease related malnutrition; Dietary Supplement: First Reference product (dextrose, containing 25 g of carbohydrates)

• Registration Number: NCT05179031
• 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

• Study First Submitted: 2021-12-14
• Study Start: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-05
• Status Verified: 2022-03
• Primary Completion: 2022-03-11
• Study Completion: 2022-03-11
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 3	Third Reference product (dextrose, containing 25 g of carbohydrates)	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 4	High protein tube feed	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 5	High-protein tube feed with additional amino acid	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 6	Oral Nutritional Supplement for diabetes patients	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 7	Oral Nutritional Supplement for diabetes patients (new formula)	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 2	Second Reference product (dextrose, containing 25 g of carbohydrates)	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 8	ONS for disease related malnutrition	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 9	Plantbased ONS for disease related malnutrition	All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Arm 1	First Reference product (dextrose, containing 25 g of carbohydrates)	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	9 test days (test days will be separated by at least 1 day in between tests for each participant)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

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