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Completed

NCT Number: NCT05179031

Assessment of the Glycemic Responses to Nutritional Products

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INQUIS Clinical Research, Ltd

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

Reference dextrose solution containing 25 g of available carbohydrates

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

Dietary Supplement

Reference dextrose solution containing 25 g of available carbohydrates

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

Dietary Supplement

Reference dextrose solution containing 25 g of available carbohydrates

High protein tube feed

Dietary Supplement

Nutritional product containing 25 g of available carbohydrates

High-protein tube feed with additional amino acid

Dietary Supplement

Nutritional product containing 25 g of available carbohydrates

Oral Nutritional Supplement for diabetes patients

Dietary Supplement

Nutritional product containing 25 g of available carbohydrates

Oral Nutritional Supplement for diabetes patients (new formula)

Dietary Supplement

Nutritional product containing 25 g of available carbohydrates

ONS for disease related malnutrition

Dietary Supplement

Nutritional product containing 25 g of available carbohydrates

Plantbased ONS for disease related malnutrition

Dietary Supplement

Nutritional product containing 25 g of available carbohydrates

Primary outcomes

  1. The glycemic index of nutritional products

    Time frame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)

Secondary outcomes

  1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references

    Time frame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)

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

    Time frame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Collaborators

  • INQUIS Clinical Research

Registry information

Official study title

Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals

Acronym: GLIN#1

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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