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Glycaemic Index Determination in Oral Nutrition Supplements

Glycaemic Index Determination in Oral Nutrition Supplements

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358716
Acronym
BEGINS
Enrollment
15
Registered
2024-04-10
Start date
2024-04-15
Completion date
2024-08-15
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism Disorders

Keywords

Glycemic index, Glucose, Post-prandial, Digestible carbohydrates

Brief 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.

Interventions

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 1

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 2

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 3

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 4

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 5

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 6

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 7

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 8

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTComplete Oral Nutrition Supplement 9

Liquid formula produced by several food ingredients to provide a balance nutrient intake

DIETARY_SUPPLEMENTGlucose

25 mg of glucose dissolved in 200 mL

Sponsors

Lactalis
CollaboratorINDUSTRY
Universitat de Lleida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic IndexPost-prandial until 120 minutes after food intakeThe 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026