Determination of glycemic response to the consumption of two specialized formulas for glycemic control

Glycemic response of individuals to the consumption of formula for enteral nutrition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-6zw2fnb

Enrollment

Unknown

Registered

2022-08-31

Start date

2018-07-16

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Hyperglycemia

Interventions

This is a single-blind, cross-over clinical study. The study initially aimed to recruit 20 participants, however, 16 healthy volunteers with normal glucose tolerance were selected. They attended fasti

G07.203.300.456

Eligibility

Age

18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; aged between 18 and 49 years; both genders; with good health conditions according to a report of absence of diabetes, renal and gastrointestinal diseases and hyperthyroidism; having a Body Mass Index (BMI) within the normal range of 18.5 to 24.9 kg/m²; with normal glucose tolerance (between 70 and 99 mg/100 mL in the morning, after fasting for 10 hours) and maximum postprandial blood glucose of 140 mg/100 mL and close to fasting after 2 hours

Exclusion criteria

Exclusion criteria: Volunteers using any type of medication that could affect digestion and absorption of food (antibiotics, medications for diarrhea and constipation) during the study period; hormone therapy; presence of pregnancy or breastfeeding; family history of diabetes; significant glycemic variations in the glycemic response test to the reference food

Design outcomes

Primary

Measure	Time frame
Expected Outcome 1: Assess reduced glycemic response after consumption of a specialized enteral formula and its modified version compared to glucose by monitoring blood glucose for 120 minutes.;Outcome 1: A mean reduction of 61.2% in glycemic response was observed after consumption of the specialized enteral formula and a reduction of 78.6% in glycemic response after consumption of its modified version compared to glucose through monitoring blood glucose for 120 minutes.;Expected Outcome 2: Evaluate the reduction in the glycemic index of a specialized enteral formula and its modified version through the ratio between the area under the curve generated by the glycemic response to the consumption of the formulas and the consumption of the reference food.;Outcome 2: A 62.2% reduction was observed in the glycemic index of the specialized enteral formula and a 78.5% reduction in the glycemic index of its modified version compared to glucose through the ratio between the area under the curve generated by the glycemic response to the consumption of formulas and the consumption of the reference food.;Expected Outcome 3: Evaluate the reduction in glycemic load of a specialized enteral formula and its modified version by calculating the relationship between the glycemic index and the amount of carbohydrates in the serving.;Outcome 3: A 73.6% reduction in the glycemic load of the specialized enteral formula and an 86% reduction in the glycemic load of its modified version was observed compared to glucose by calculating the relationship between the glycemic index and the amount of carbohydrates in the portion.	—

Measure

Time frame

Expected Outcome 1: Assess reduced glycemic response after consumption of a specialized enteral formula and its modified version compared to glucose by monitoring blood glucose for 120 minutes.;Outcome 1: A mean reduction of 61.2% in glycemic response was observed after consumption of the specialized enteral formula and a reduction of 78.6% in glycemic response after consumption of its modified version compared to glucose through monitoring blood glucose for 120 minutes.;Expected Outcome 2: Evaluate the reduction in the glycemic index of a specialized enteral formula and its modified version through the ratio between the area under the curve generated by the glycemic response to the consumption of the formulas and the consumption of the reference food.;Outcome 2: A 62.2% reduction was observed in the glycemic index of the specialized enteral formula and a 78.5% reduction in the glycemic index of its modified version compared to glucose through the ratio between the area under the curve generated by the glycemic response to the consumption of formulas and the consumption of the reference food.;Expected Outcome 3: Evaluate the reduction in glycemic load of a specialized enteral formula and its modified version by calculating the relationship between the glycemic index and the amount of carbohydrates in the serving.;Outcome 3: A 73.6% reduction in the glycemic load of the specialized enteral formula and an 86% reduction in the glycemic load of its modified version was observed compared to glucose by calculating the relationship between the glycemic index and the amount of carbohydrates in the portion.

—

Secondary

Measure	Time frame
Secondary outcomes are not expected.	—

Countries

Brazil

Contacts

Public ContactAna Zanini

Prodiet Medical Nutrition

cientifico@prodiet.com.br+55 (41)33422825

Outcome results

None listed

Source: REBEC (via WHO ICTRP)