Assessment of the Glycemic Responses to Nutritional Products (GLIN#1)
Status
Completed
Conditions
Glycemic Response
Treatments
Dietary Supplement: ONS for disease related malnutrition
Dietary Supplement: Plantbased ONS for disease related malnutrition
Dietary Supplement: High protein tube feed
Dietary Supplement: Third Reference product (dextrose, containing 25 g of carbohydrates)
Dietary Supplement: Oral Nutritional Supplement for diabetes patients (new formula)
Dietary Supplement: First Reference product (dextrose, containing 25 g of carbohydrates)
Dietary Supplement: High-protein tube feed with additional amino acid
Dietary Supplement: Oral Nutritional Supplement for diabetes patients
Dietary Supplement: Second Reference product (dextrose, containing 25 g of carbohydrates)
Details and patient eligibility
About
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.
Enrollment
13 patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
13 participants in 9 patient groups
Arm 1
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: First Reference product (dextrose, containing 25 g of carbohydrates)
Arm 2
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Second Reference product (dextrose, containing 25 g of carbohydrates)
Arm 3
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Third Reference product (dextrose, containing 25 g of carbohydrates)
Arm 4
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: High protein tube feed
Arm 5
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: High-protein tube feed with additional amino acid
Arm 6
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Oral Nutritional Supplement for diabetes patients
Arm 7
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Oral Nutritional Supplement for diabetes patients (new formula)
Arm 8
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: ONS for disease related malnutrition
Arm 9
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Plantbased ONS for disease related malnutrition
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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