Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382480
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-15
Brief Title:
PROTeIn-rich Meals to Control Glucose
Sponsor:
German Institute of Human Nutrition
Organization:
German Institute of Human Nutrition
Study Overview
Official Title:
Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTIME
Brief 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
Detailed 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 HPHC intervention vs a HC breakfast and a HP dinner HCHP intervention - divided by a 4-week wash-out phase A HP low-carb meal breakfast or dinner will contain 35E protein 35E carbs and 30E fat and a HC meal breakfast or dinner will contain 10Eprotein 60E carbs and 30E fat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None