Glycaemic Index Determination in Oral Nutrition Supplements

Glucose Metabolism Disorders Clinical Trial

— BEGINS  

Official title:

Glycaemic Index Determination in Oral Nutrition Supplements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358716
• Other study ID #: CEIC-3037
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2024
• Source: Universitat de Lleida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response.

Description:

The determination of the glycemic index will be conducted following the protocol described in the International Standard Organization 26642. Specifically, the glycemic response of each food will be determined in 15 healthy volunteers, using a glucose-containing beverage with 25 g of glucose in 200 mL as a control for glycemic response measurement. The amount of food each volunteer will test will be equivalent to an intake of 25 g of digestible carbohydrates in a single intake. Subsequently, increases in blood glucose levels will be recorded at 15, 30, 45, 60, 90, and 120 minutes after initiating the food intake. Blood glucose measurements will be performed using a portable glucometer via capillary blood. The area under the curve of the increase in glucemia will be estimated using the trapezoidal method, and these will be compared with the glucose increases provided by the glucose-containing beverage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers with no known food allergy or intolerance and pharmacological treatments known to affect glucose tolerance (excluding oral contraceptives)

Exclusion Criteria:

• Known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.

• Any acute, chronic disease or any other serious complications that may interfere with glucose metabolism.

• Subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.

• Subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion

• A major medical or surgical event requiring hospitalization within the preceding 3 months.

• Pregnancy

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• Complete Oral Nutrition Supplement 1
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 2
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 3
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 4
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 5
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 6
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 7
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 8
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Complete Oral Nutrition Supplement 9
Liquid formula produced by several food ingredients to provide a balance nutrient intake
• Glucose
25 mg of glucose dissolved in 200 mL

Locations

Country	Name	City	State
Spain	University of Lleida	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Universitat de Lleida	Lactalis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Index	The area under the curve of glucose levels after the post-prandial intake of the oral nutrition supplement compared with the area under the curve of glucose levels after a post-prandial intake of a glucose solution	Post-prandial until 120 minutes after food intake