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

NCT05335863 | Completed

• 1 other identifier: HULP 5921
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetes; oral nutritional supplement; glycemic index; healthy population

Outcome Measures

Primary Outcomes (1)

• Areas under the glucose metabolism curve for the determination of the glycemic index

  Statistical calculation of the area under the curve at different times of blood collection (baseline, 0, 30, 60, 90 and 120 minutes)

  0-120 minutes

Study Arms (2)

Experimental

EXPERIMENTAL

Ingestion of FontActiv® DiaBest high protein/hypercaloric

Dietary Supplement: Oral Nutritional Supplement

Control

PLACEBO COMPARATOR

Ingestion of glucose standard solution

Dietary Supplement: Glucose

Interventions

Oral Nutritional Supplement DIETARY_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.

Also known as: Experimental

Experimental

Glucose DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 65 years
• Patients without chronic uncontrolled diseases
• Patients willing to consume the Oral Nutritional Supplement (ONS) to carry out the study
• Patients with adequate cultural level and understanding of the clinical study
• Patients who agree to voluntarily participate in the study and who give their informed consent in writing

You may not qualify if:

• Subjects with any serious chronic pathology.
• Subjects with metabolic or intestinal pathologies that interfere with the homeostatic mechanisms of glucose
• Subjects with neurological pathologies or eating disorders that interfere with acute tests.
• Subjects with allergies or intolerances to any of the ingredients in the formula
• Subjects with socio-family problems that prevent them from participating in the study
• Subjects with intense physical activity
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Fundacio Eurecat: collaborator

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Dietary Supplements; Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Bricia López-Plaza, MsC, PhD

  Instituto de Investigación Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossed, controlled and randomized clinical trial

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: April 20, 2022
• Study Start: November 3, 2021
• Primary Completion: December 23, 2021
• Study Completion: February 9, 2022
• Last Updated: May 30, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)