Assessment of the Glycemic Responses to Nutritional Products (v2.0)

Glycemic Response Clinical Trial

— GLIN#2  

Official title:

Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals (v2.0)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308147
• Other study ID #: INQ-2137 v2.0
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Glycemic Response

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