Intermittent Eating on Glucose Homeostasis in Prediabetes

NCT05717387 | Unknown

• 1 other identifier: NFEC-2023-017
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes; Obesity

Keywords

TRE; The 5:2 diet; Glucose Homeostasis; prediabetes; obesity

Outcome Measures

Primary Outcomes (1)

• Change in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.

  Baseline to months 6

Secondary Outcomes (21)

• Change in mean glucose levels

  Baseline and months 6

• Change in glycemic variability

  Baseline and months 6

• Change in percent of time below range

  Baseline and months 6

• Change in percent of time above range

  Baseline and months 6

• Change in resting metabolic rate

  Baseline and months 6

Study Arms (3)

Time-restricted eating

EXPERIMENTAL

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

Behavioral: Time-restricted eating

the 5:2 diet

EXPERIMENTAL

Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.

Behavioral: The 5:2 diet

Control

NO INTERVENTION

Participants in the control group will receive a general lifestyle counseling.

Interventions

Time-restricted eating BEHAVIORAL

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

Time-restricted eating

The 5:2 diet BEHAVIORAL

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

the 5:2 diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18-75 years;
• Prediabetes;
• Body mass index (BMI)of 28.0 to 45.0 kg/m2;

You may not qualify if:

• History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
• Diagnosis of type 1 and type 2 diabetes;
• History of malignant tumors;
• Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
• History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
• History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
• History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
• Being a smoker or having been a smoker in the 3 months prior to their screening visit;
• Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
• Currently participating in weight loss programs;
• Women who are pregnant or plan to become pregnant;
• Patients who cannot be followed for 24 months (due to a health situation or migration);
• Patients who are unwilling or unable to give informed consent.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Huijie Zhang, MD.PhD

  Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huijie Zhang, MD.PhD

CONTACT

+86-020-61641635; Huijiezhang2005@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: April 11, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CN (1)