Glycaemic Index Determination in Oral Nutrition Supplements (BEGINS)

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.

Study Overview

• Status: Recruiting
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Complete Oral Nutrition Supplement 1; Dietary supplement: Complete Oral Nutrition Supplement 2; Dietary supplement: Complete Oral Nutrition Supplement 3; Dietary supplement: Complete Oral Nutrition Supplement 4; Dietary supplement: Complete Oral Nutrition Supplement 5; 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Recruiting
    • University of Lleida
    • Contact: Jose Serrano, PhD; Phone Number: 973702408; Email: josecarlos.serrano@udl.cat
    • Contact: Manuel Portero, PhD; Phone Number: 973702408; Email: manuel.portero@udl.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nutritional Supplement 1	Dietary supplement: Complete Oral Nutrition Supplement 1; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 2	Dietary supplement: Complete Oral Nutrition Supplement 2; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 3	Dietary supplement: Complete Oral Nutrition Supplement 3; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 4	Dietary supplement: Complete Oral Nutrition Supplement 4; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 5	Dietary supplement: Complete Oral Nutrition Supplement 5; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 6	Dietary supplement: Complete Oral Nutrition Supplement 6; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 7	Dietary supplement: Complete Oral Nutrition Supplement 7; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 8	Dietary supplement: Complete Oral Nutrition Supplement 8; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Experimental: Oral Nutritional Supplement 9	Dietary supplement: Complete Oral Nutrition Supplement 9; Liquid formula produced by several food ingredients to provide a balance nutrient intake
Active Comparator: Glucose; Glucose solution	Dietary supplement: Glucose; 25 mg of glucose dissolved in 200 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitat de Lleida
• Collaborators: Lactalis

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Glucose; Glycemic index; Post-prandial; Digestible carbohydrates
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: CEIC-3037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No