NCT06358716

Glycaemic Index Determination in Oral Nutrition Supplements

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Universitat de Lleida · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Glucose Metabolism Disorders

Interventions

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

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-07-15
• Completion: 2024-08-15
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: Spain