Glin3: Assessment of the Glycemic Responses to Nutritional Products
NCT ID: NCT06215534
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2024-02-07
2024-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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arm 1
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
first reference product series 1
dextrose (containing 25 grams of carbohydrates)
arm 2
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
second reference product seies 1
dextrose (containing 25 grams of carbohydrates)
arm 3
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
third reference product series 1
dextrose (containing 25 grams of carbohydrates)
arm 4
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
first concept product series 1
Standard tube feed (containing 25 grams of carbohydrates)
arm 5
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
second concept product series 1
Tube feed with added fibers (containing 25 grams of carbohydrates)
arm 6
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
third concept product series 1
Tube feed with extra energy (containing 25 grams of carbohydrates)
arm 7
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
4th concept product seris 1
Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)
arm 8
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
5th concept product series 1
Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates
arm 9
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
6th concept product series 1
Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates
arm 10
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
1st reference product series 2
dextrose (containing 25 grams of carbohydrates)
arm 11
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
2nd reference product series 2
dextrose (containing 25 grams of carbohydrates)
arm 12
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
3rd reference product series 2
dextrose (containing 25 grams of carbohydrates)
arm 13
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
1st concept product series 2
High energy plant based tube feed (containing 25 grams of carbohydrates)
arm 14
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
2nd concept product series 2
High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)
arm 15
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
3rd concept product series 2
High protein tube feed (containing 25 grams of carbohydrates)
arm 16
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
4th concept product series 2
High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)
arm 17
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
5th concept product series 2
Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)
arm 18
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
6th concept product series 2
Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)
Interventions
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first reference product series 1
dextrose (containing 25 grams of carbohydrates)
second reference product seies 1
dextrose (containing 25 grams of carbohydrates)
third reference product series 1
dextrose (containing 25 grams of carbohydrates)
first concept product series 1
Standard tube feed (containing 25 grams of carbohydrates)
second concept product series 1
Tube feed with added fibers (containing 25 grams of carbohydrates)
third concept product series 1
Tube feed with extra energy (containing 25 grams of carbohydrates)
4th concept product seris 1
Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)
5th concept product series 1
Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates
6th concept product series 1
Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates
1st reference product series 2
dextrose (containing 25 grams of carbohydrates)
2nd reference product series 2
dextrose (containing 25 grams of carbohydrates)
3rd reference product series 2
dextrose (containing 25 grams of carbohydrates)
1st concept product series 2
High energy plant based tube feed (containing 25 grams of carbohydrates)
2nd concept product series 2
High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)
3rd concept product series 2
High protein tube feed (containing 25 grams of carbohydrates)
4th concept product series 2
High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)
5th concept product series 2
Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)
6th concept product series 2
Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Nutricia Research
INDUSTRY
Responsible Party
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Locations
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Inquis Clinical research
Toronto, , Canada
Countries
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Other Identifiers
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23REX0060928
Identifier Type: -
Identifier Source: org_study_id
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