Assessment of the Glycemic Responses to Nutritional Products

NCT05179031 | Completed

• 1 other identifier: INQ-2137
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Glycemic response; Glycemic index; Nutritional products; Healthy individuals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (9)

Arm 1

OTHER

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)

Arm 2

OTHER

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)

Arm 3

OTHER

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)

Arm 4

OTHER

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

Dietary Supplement: High protein tube feed

Arm 5

OTHER

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

Arm 6

OTHER

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

Arm 7

OTHER

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)

Arm 8

OTHER

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

Arm 9

OTHER

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

Interventions

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

Reference dextrose solution containing 25 g of available carbohydrates

Arm 1

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

Reference dextrose solution containing 25 g of available carbohydrates

Arm 2

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

Reference dextrose solution containing 25 g of available carbohydrates

Arm 3

High protein tube feed DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 4

High-protein tube feed with additional amino acid DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 5

Oral Nutritional Supplement for diabetes patients DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 6

Oral Nutritional Supplement for diabetes patients (new formula) DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 7

ONS for disease related malnutrition DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 8

Plantbased ONS for disease related malnutrition DIETARY_SUPPLEMENT

Nutritional product containing 25 g of available carbohydrates

Arm 9

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 65 years
• Body mass index (BMI) between 18.5 and 27 kg/m²

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Research: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

INQUIS Clinical Research, Ltd

Toronto, Ontario, M5C 2N8, Canada

Location

MeSH Terms

Interventions

Glucose; Carbohydrates; Dietary Supplements

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 5, 2022
• Study Start: January 4, 2022
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)