Glycaemic Index Determination in Oral Nutrition Supplements

Last updated: April 5, 2024
Sponsor: Universitat de Lleida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Disorders

Treatment

Complete Oral Nutrition Supplement 9

Complete Oral Nutrition Supplement 3

Complete Oral Nutrition Supplement 1

Clinical Study ID

NCT06358716
CEIC-3037
  • Ages 21-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin totreat diabetes and related conditions.
  • Any acute, chronic disease or any other serious complications that may interfere withglucose 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 3months.
  • Pregnancy

Study Design

Total Participants: 15
Treatment Group(s): 10
Primary Treatment: Complete Oral Nutrition Supplement 9
Phase:
Study Start date:
April 15, 2024
Estimated Completion Date:
August 15, 2024

Study 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.

Connect with a study center

  • University of Lleida

    Lleida, 25198
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.