Glin3: Assessment of the Glycemic Responses to Nutritional Products

NCT06215534 | Completed

• 1 other identifier: 23REX0060928
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glycemic Response

Keywords

Glycemic response; Glycemic Index; Nutritional products; Healthy individuals

Outcome Measures

Primary Outcomes (1)

• The glycemic index of nutritional products

  6 months

Secondary Outcomes (2)

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

  6 months

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

  6 months

Study Arms (18)

arm 1

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: first reference product series 1

arm 2

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: second reference product seies 1

arm 3

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: third reference product series 1

arm 4

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: first concept product series 1

arm 5

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: second concept product series 1

arm 6

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: third concept product series 1

arm 7

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 4th concept product seris 1

arm 8

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 5th concept product series 1

arm 9

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 6th concept product series 1

arm 10

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 1st reference product series 2

arm 11

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 2nd reference product series 2

arm 12

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 3rd reference product series 2

arm 13

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 1st concept product series 2

arm 14

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 2nd concept product series 2

arm 15

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 3rd concept product series 2

arm 16

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 4th concept product series 2

arm 17

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 5th concept product series 2

arm 18

OTHER

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Dietary Supplement: 6th concept product series 2

Interventions

first reference product series 1 DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

arm 1

second reference product seies 1 DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

arm 2

third reference product series 1 DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

arm 3

first concept product series 1 DIETARY_SUPPLEMENT

Standard tube feed (containing 25 grams of carbohydrates)

arm 4

second concept product series 1 DIETARY_SUPPLEMENT

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

arm 5

third concept product series 1 DIETARY_SUPPLEMENT

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

arm 6

4th concept product seris 1 DIETARY_SUPPLEMENT

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

arm 7

5th concept product series 1 DIETARY_SUPPLEMENT

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

arm 8

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

arm 9

1st reference product series 2 DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

arm 10

2nd reference product series 2 DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

arm 11

3rd reference product series 2 DIETARY_SUPPLEMENT

dextrose (containing 25 grams of carbohydrates)

arm 12

1st concept product series 2 DIETARY_SUPPLEMENT

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

arm 13

2nd concept product series 2 DIETARY_SUPPLEMENT

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

arm 14

3rd concept product series 2 DIETARY_SUPPLEMENT

High protein tube feed (containing 25 grams of carbohydrates)

arm 15

4th concept product series 2 DIETARY_SUPPLEMENT

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

arm 16

5th concept product series 2 DIETARY_SUPPLEMENT

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

arm 17

6th concept product series 2 DIETARY_SUPPLEMENT

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

arm 18

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 65 years
• Body mass index (BMI) between 18.5 and 27 kg/m²

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Inquis Clinical research

Toronto, M5C 2N8, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 12 products will be tested (2 x 6 products + each 3 contls) that means 18 ärms"in total

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 7, 2024
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)