Hiperglycemia
Conditions
Interventions
This is a single-blind, cross-over clinical study. The study initially aimed to recruit 20 participants, however, 15 healthy volunteers with normal glucose tolerance were selected. They attended fasti
G07.203.300.456
Sponsors
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Eligibility
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers; aged between 18 and 45 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 oral nutritional supplement and a specialized high-protein enteral formula for glycemic control compared to glucose by monitoring blood glucose for 120 minutes.;Outcome 1: A mean reduction of 71.3% in glycemic response was observed after consumption of the specialized oral supplement and a reduction of 73.9% in glycemic response after consumption of the specialized high-protein enteral formula compared to glucose through monitoring blood glucose for 120 minutes.;Expected Outcome 2: Evaluate the reduction in the glycemic index of a specialized oral nutritional supplement and a specialized high-protein enteral formula for glycemic control 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 73.4% reduction was observed in the glycemic index of the specialized oral nutritional supplement and a 76.7% reduction in the glycemic index of the specialized high-protein enteral formula 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 oral nutritional supplement and a specialized high-protein enteral formula for glycemic control by calculating the relationship between the glycemic index and the amount of carbohydrates in the serving.;Outcome 3: A 69.6% reduction in the glycemic load of the specialized oral nutritional supplement and an 66.8% reduction in the glycemic load of the specialized high-protein enteral formula 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
Outcome results
None listed