Intermittent Eating on Glucose Homeostasis in Prediabetes

NCT05717387 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-11-09

No results posted yet for this study

Summary

Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.

Conditions

Interventions

BEHAVIORAL

Time-restricted eating

Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).

BEHAVIORAL

The 5:2 diet

Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Huijie Zhang, MD.PhD · Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-11
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717387 on ClinicalTrials.gov