Assessment of the Glycemic Responses to Nutritional Products

NCT ID: NCT05179031

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2022-03-11

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.

Conditions

Glycemic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

First Reference product (dextrose, containing 25 g of carbohydrates)

Intervention Type: DIETARY_SUPPLEMENT

Reference dextrose solution containing 25 g of available carbohydrates

Arm 2

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

Second Reference product (dextrose, containing 25 g of carbohydrates)

Intervention Type: DIETARY_SUPPLEMENT

Reference dextrose solution containing 25 g of available carbohydrates

Arm 3

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

Third Reference product (dextrose, containing 25 g of carbohydrates)

Intervention Type: DIETARY_SUPPLEMENT

Reference dextrose solution containing 25 g of available carbohydrates

Arm 4

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

High protein tube feed

Intervention Type: DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 5

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

High-protein tube feed with additional amino acid

Intervention Type: DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 6

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

Oral Nutritional Supplement for diabetes patients

Intervention Type: DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 7

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

Oral Nutritional Supplement for diabetes patients (new formula)

Intervention Type: DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 8

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

ONS for disease related malnutrition

Intervention Type: DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 9

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group Type: OTHER

Plantbased ONS for disease related malnutrition

Intervention Type: DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Interventions

First Reference product (dextrose, containing 25 g of carbohydrates)

Reference dextrose solution containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

Second Reference product (dextrose, containing 25 g of carbohydrates)

Reference dextrose solution containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

Third Reference product (dextrose, containing 25 g of carbohydrates)

Reference dextrose solution containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

High protein tube feed

Nutritional product containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

High-protein tube feed with additional amino acid

Nutritional product containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

Oral Nutritional Supplement for diabetes patients

Nutritional product containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

Oral Nutritional Supplement for diabetes patients (new formula)

Nutritional product containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

ONS for disease related malnutrition

Nutritional product containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

Plantbased ONS for disease related malnutrition

Nutritional product containing 25 g of available carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

INQUIS Clinical Research

INDUSTRY

Sponsor Role: collaborator

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

INQUIS Clinical Research, Ltd

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

INQ-2137

Identifier Type: -

Identifier Source: org_study_id