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Glycemic Index Evaluation of a Hypercaloric/High-protein Nutritional Supplement in Healthy Adults

NCT05335863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-30

No results posted yet for this study

Summary

Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population, especially in the elderly population.The main consequence of the alteration of DM is the increase in blood glucose levels. When the concentration reaches levels above 180-200 mg / dl after ingestion, the following symptoms appear: polyphagia, polydipsia, polyuria and weight loss. Diet, on some occasions, is the only therapy necessary. The commercialized formulas considered as "standard", have a high content of carbohydrates with a high glycemic index (approximately 50%) and low in lipids (30-35%) and do not usually contain fiber. This type of liquid formulations seem to increase the insulin and glycemic response in healthy people, and to a greater extent in patients with DM, compared to what would cause a similar intake of nutrients in a mixed diet.

All diabetic formulas provide carbohydrates with low glycemic index. They are made from starches, with a variable contribution of fructose, which in all cases should be less than 20% of the total caloric intake, due to its lower glycemic index, its greater sweetening power and its entry into the cell is insulin-independent. However, it is necessary to determine the glycemic index of the new specific formulas for this population through clinical trials.Based on these initial facts, researchers consider it appropriate to carry out a pilot study to evaluate the glycemic index of a Oral Nutritional Supplement (ONS) especially indicated for diabetic people in a group of healthy people.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Oral Nutritional Supplement

Participants must consume 416 mL of ONS FontActiv® DiaBest HP / HC vanilla flavor. A maximum time of 10 min will be given to consume the entire product.

DIETARY_SUPPLEMENT

Glucose

Participants must consume a 50 g glucose solution in 10 min to obtain the ares under the curve (AUC) data from glucose consumption

Sponsors & Collaborators

  • Fundacio Eurecat

    collaborator UNKNOWN

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Bricia López-Plaza, MsC, PhD · Instituto de Investigación Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2021-12-23
Completion
2022-02-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335863 on ClinicalTrials.gov