Glycaemic Index Determination in Oral Nutrition Supplements (BEGINS)

Universitat de Lleida

Status: Enrolling

Conditions: Glucose Metabolism Disorders

Treatments: Dietary Supplement: Complete Oral Nutrition Supplement 4; Dietary Supplement: Complete Oral Nutrition Supplement 6; Dietary Supplement: Complete Oral Nutrition Supplement 7; Dietary Supplement: Complete Oral Nutrition Supplement 8; Dietary Supplement: Complete Oral Nutrition Supplement 9; Dietary Supplement: Glucose; Dietary Supplement: Complete Oral Nutrition Supplement 1; Dietary Supplement: Complete Oral Nutrition Supplement 5; Dietary Supplement: Complete Oral Nutrition Supplement 3; Dietary Supplement: Complete Oral Nutrition Supplement 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06358716

CEIC-3037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

15 participants in 10 patient groups

Oral Nutritional Supplement 1

Experimental group

Description:

Oral Nutritional Supplement 1

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 1

Oral Nutritional Supplement 2

Experimental group

Description:

Oral Nutritional Supplement 2

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 2

Oral Nutritional Supplement 3

Experimental group

Description:

Oral Nutritional Supplement 3

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 3

Oral Nutritional Supplement 4

Experimental group

Description:

Oral Nutritional Supplement 4

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 4

Oral Nutritional Supplement 5

Experimental group

Description:

Oral Nutritional Supplement 5

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 5

Oral Nutritional Supplement 6

Experimental group

Description:

Oral Nutritional Supplement 6

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 6

Oral Nutritional Supplement 7

Experimental group

Description:

Oral Nutritional Supplement 7

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 7

Oral Nutritional Supplement 8

Experimental group

Description:

Oral Nutritional Supplement 8

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 8

Oral Nutritional Supplement 9

Experimental group

Description:

Oral Nutritional Supplement 9

Treatment:

Dietary Supplement: Complete Oral Nutrition Supplement 9

Glucose

Active Comparator group

Description:

Glucose solution

Treatment:

Dietary Supplement: Glucose