NCT02442024

Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.

Detailed description

An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol. On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Modified Diet	Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.
BEHAVIORAL	Standard Diet	Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2015-05-13
• Last updated: 2015-05-13

Locations

1 site across 1 country: Italy