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PROTeIn-rich Meals to Control Glucose — PROTIME  

Obesity Clinical Trial

Official title:
Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes

Clinical Trial Summary

The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.

Clinical Trial Description

Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06382480
Study type Interventional
Source German Institute of Human Nutrition
Contact Olga Ramich, PD Dr.
Phone +4933200882749
Email olga.ramich@dife.de
Status Recruiting
Phase N/A
Start date April 12, 2024
Completion date February 28, 2027
View Details
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