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Completed

NCT Number: NCT06797349

Glin4: 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

Phase 4

Primary location

INQUIS Clinical Research, Ltd , 20 Victoria Street, 3rd Floor

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

  • 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

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

Second Reference Product

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

Third Reference Product

Dietary Supplement

dextrose (containing 25 grams of carbohydrates)

First Concept Product

Dietary Supplement

Plant-Based Oat Beverage with Sugar 1 (containing 25 grams of carbohydrates)

Second Concept Product

Dietary Supplement

Plant-Based Oat Beverage with Sugar 2 (containing 25 grams of carbohydrates)

Third Concept product

Dietary Supplement

Plant-Based Oat Beverage with Sugar 3 (containing 25 grams of carbohydrates)

Fourth Concept product

Dietary Supplement

Plant-Based Oat Beverage with Sugar 4 (containing 25 grams of carbohydrates)

Fifth Concept product

Dietary Supplement

Plant-Based Oat Beverage No Sugar 1(containing 25 grams of carbohydrates

Sixth Concept product

Dietary Supplement

Plant-Based Oat Beverage No Sugar 2 (containing 25 grams of carbohydrates

Seventh Concept product

Dietary Supplement

High calorie, high protein oral powder nutritional supplement. (containing 25 grams of carbohydrates

Primary outcomes

  1. The glycemic index of nutritional products

    Time frame: from enrollment to the end of treatment at about 9 weeks

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: from enrollment to the end of treatment at about 9 weeks

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

    Time frame: from enrollment to the end of treatment at about 9 weeks

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: GLIN4

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
May 23, 2025

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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