Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus, Type 2 Nutrition, Healthy Obesity Weight Loss

Outcome Measures

Primary Outcomes (1)

Glycemic control
Change in plasma levels of glycated hemoglobin
12 weeks

Secondary Outcomes (2)

Glucose tolerance
12 weeks
Body weight loss
12 weeks

Other Outcomes (2)

Daily glucose variability
14 days
Beta cell function
12 weeks

Study Arms (2)

eTRC diet

EXPERIMENTAL

Behavioral: eTRC diet

Control diet

ACTIVE COMPARATOR

Behavioral: Control diet

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

eTRC diet

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 Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

age 18-75 years
both males and females

Sponsors & Collaborators

Azienda Ospedaliero, Universitaria Pisana
Otherlead

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

Related Publications (1)

Trico D, Masoni MC, Baldi S, Cimbalo N, Sacchetta L, Scozzaro MT, Nesti G, Mengozzi A, Nesti L, Chiriaco M, Natali A. Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. Diabetologia. 2024 Feb;67(2):263-274. doi: 10.1007/s00125-023-06045-9. Epub 2023 Nov 16.
PMID: 37971503DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityWeight Loss

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

Andrea Natali, MD
University of Pisa
PRINCIPAL INVESTIGATOR

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Full Professor of Nutrition

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

March 1, 2019

Actual (reported)

Metabolic Effects of Early Time-restricted Carbohydrate Consumption

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Study Arms (2)

eTRC diet

Control diet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Study Arms (2)

eTRC diet

Control diet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations