Metabolic Effects of Early Time-restricted Carbohydrate Consumption

Azienda Ospedaliero, Universitaria Pisana27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Obesity Nutrition, Healthy Weight Loss

Interventions

eTRC dietBEHAVIORAL

12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch

Control dietBEHAVIORAL

12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Outcomes

Primary Outcomes

Glycemic control

Change in plasma levels of glycated hemoglobin

Time frame: 12 weeks

Secondary Outcomes

Glucose tolerance

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)

Time frame: 12 weeks

Body weight loss

Change in body weight

Time frame: 12 weeks

Data from ClinicalTrials.gov

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