CompletedPhase 4

Glin4: Assessment of the Glycemic Responses to Nutritional Products

Canada12 participantsStarted 2025-01-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

The glycemic index of nutritional products

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

Trial details

NCT IDNCT06797349

SponsorNutricia Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-04

View on ClinicalTrials.gov More Glycemic Response trials