Metabolic Effects of Early Time-restricted Carbohydrate Consumption

Not Applicable

Completed

• Conditions: Nutrition, Healthy; Obesity; Diabetes Mellitus, Type 2; Weight Loss
• Interventions: Behavioral: Control diet; Behavioral: eTRC diet

• Registration Number: NCT05713058
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• age 18-75 years
• both males and females
• type 2 diabetes

Exclusion Criteria

• type 1 diabetes
• insulin treatment
• pharmacological treatment for weight loss
• pregnancy
• other acute or chronic conditions influencing body weight and glucose metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control diet	Control diet	-
eTRC diet	eTRC diet	-

Primary Outcome Measures

Name	Time	Method
Glycemic control	12 weeks	Change in plasma levels of glycated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Body weight loss	12 weeks	Change in body weight
Glucose tolerance	12 weeks	Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute mixed meal tolerance test (MMTT)

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy