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Completed

NCT Number: NCT06215534

Glin3: 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

Toronto, 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

  • Baseline fasting Glucose ≥6.1 at screening visit
  • 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 series 1

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

second reference product seies 1

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

third reference product series 1

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

first concept product series 1

Dietary Supplement

Standard tube feed (containing 25 grams of carbohydrates)

second concept product series 1

Dietary Supplement

Tube feed with added fibers (containing 25 grams of carbohydrates)

third concept product series 1

Dietary Supplement

Tube feed with extra energy (containing 25 grams of carbohydrates)

4th concept product seris 1

Dietary Supplement

Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)

5th concept product series 1

Dietary Supplement

Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates

6th concept product series 1

Dietary Supplement

Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates

1st reference product series 2

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

2nd reference product series 2

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

3rd reference product series 2

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

1st concept product series 2

Dietary Supplement

High energy plant based tube feed (containing 25 grams of carbohydrates)

2nd concept product series 2

Dietary Supplement

High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)

3rd concept product series 2

Dietary Supplement

High protein tube feed (containing 25 grams of carbohydrates)

4th concept product series 2

Dietary Supplement

High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)

5th concept product series 2

Dietary Supplement

Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)

6th concept product series 2

Dietary Supplement

Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)

Primary outcomes

  1. The glycemic index of nutritional products

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

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#3

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Aug 1, 2024

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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