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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

April 5, 2024

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed

5 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed

Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 5, 2024

Last Update Submit

April 5, 2024

Conditions

Glucose Metabolism Disorders

Keywords

Glycemic indexGlucosePost-prandialDigestible carbohydrates

Outcome Measures

Primary Outcomes (1)

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

Study Arms (10)

Oral Nutritional Supplement 1

EXPERIMENTAL

Oral Nutritional Supplement 1

Dietary Supplement: Complete Oral Nutrition Supplement 1

Oral Nutritional Supplement 2

EXPERIMENTAL

Oral Nutritional Supplement 2

Dietary Supplement: Complete Oral Nutrition Supplement 2

Oral Nutritional Supplement 3

EXPERIMENTAL

Oral Nutritional Supplement 3

Dietary Supplement: Complete Oral Nutrition Supplement 3

Oral Nutritional Supplement 4

EXPERIMENTAL

Oral Nutritional Supplement 4

Dietary Supplement: Complete Oral Nutrition Supplement 4

Oral Nutritional Supplement 5

EXPERIMENTAL

Oral Nutritional Supplement 5

Dietary Supplement: Complete Oral Nutrition Supplement 5

Oral Nutritional Supplement 6

EXPERIMENTAL

Oral Nutritional Supplement 6

Dietary Supplement: Complete Oral Nutrition Supplement 6

Oral Nutritional Supplement 7

EXPERIMENTAL

Oral Nutritional Supplement 7

Dietary Supplement: Complete Oral Nutrition Supplement 7

Oral Nutritional Supplement 8

EXPERIMENTAL

Oral Nutritional Supplement 8

Dietary Supplement: Complete Oral Nutrition Supplement 8

Oral Nutritional Supplement 9

EXPERIMENTAL

Oral Nutritional Supplement 9

Dietary Supplement: Complete Oral Nutrition Supplement 9

Glucose

ACTIVE COMPARATOR

Glucose solution

Dietary Supplement: Glucose