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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05308147
Other study ID # INQ-2137 v2.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 17, 2022
Est. completion date May 31, 2022

Study information

Verified date March 2022
Source Nutricia Research
Contact Danone Nutricia Research
Phone +31 30 2095 000
Email register.clinicalresearchnutricia@danone.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date May 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
First Reference product
Dextrose (containing 25 grams of carbohydrates)
Second Reference product
Dextrose (containing 25 grams of carbohydrates)
Third Reference product
Dextrose (containing 25 grams of carbohydrates)
First Concept product
Infant Formula (containing 25 grams of carbohydrates)
Second Concept product
Infant Formula with new carbohydrate mixture 1 (containing 25 grams of carbohydrates)
Third Concept product
Infant Formula with new carbohydrate mixture 2 (containing 25 grams of carbohydrates)

Locations

Country Name City State
Canada INQUIS Clinical Research, Ltd Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Nutricia Research

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The glycemic index of nutritional products 3 months
Secondary The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references 3 months
Secondary The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references 3 months
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