Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial) (TRIG)

Study to Evaluate the Effects of Time-Restricted Eating Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation

We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Impaired Glucose Regulation; Overweight/Obese; Time-restricted Eating
• Intervention / Treatment: Behavioral: Reduced Calorie Diet (RCD); Behavioral: Time Restricted eating(TRE)

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥ 18 year
2. Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment
3. Body mass index (BMI)of 23.0 to 45.0 kg/m2;

Exclusion Criteria:

1. Confirmed diagnosis of DM or on hypoglycaemic treatment
2. Women who are pregnant or breast-feeding at recruitment
3. Patients taking glucocorticoid at recruitment
4. Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
5. 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);
6. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
7. 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;
8. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
9. Patients who cannot be followed for 24 months (due to a health situation or migration);
10. Patients who are unwilling or unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RCD; Participants in this group will focus on standard care with daily reduced calorie diet (RCD)	Behavioral: Reduced Calorie Diet (RCD); Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
Experimental: TRE; Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction.	Behavioral: Time Restricted eating(TRE); Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later, Participants will receive a diet of 1200-1500kcal/d without a restriction of eating time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of regression to normoglycaemia among the studied population	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum fasting insulin levels (pmol/L)		3 months, 6 months and 12 months
Changes in body weight (Kilograms)		3 months, 6 months and 12 months
Changes in waist circumference (cm)		3 months, 6 months and 12 months
Change in body mass index (kg/m2)		3 months, 6 months and 12 months
Changes in systolic pressure (mmHg)		3 months, 6 months and 12 months
Changes in diastolic pressure (mmHg）		3 months, 6 months and 12 months
Changes in fasting blood glucose (mmol/L)		3 months, 6 months and 12 months
Change in β cell function	β cell function will be assessed by HOMA-β	3 months, 6 months and 12 months
Change in insulin sensitivity	Insulin sensitivity will be assessed by HOMA-IR	3 months, 6 months and 12 months
Changes in serum total cholesterol levels (mmol/L)		3 months, 6 months and 12 months
Changes in serum low density lipoprotein cholesterol levels (mmol/L)		3 months, 6 months and 12 months
Changes in serum triglyceride levels (mmol/L)		3 months, 6 months and 12 months
Changes in serum high density lipoprotein cholesterol levels (mmol/L)		3 months, 6 months and 12 months
Changes in serum alanine aminotransferase levels levels (mmol/L)		3 months, 6 months and 12 months
Changes in serum aspartate aminotransferase levels (mmol/L)		3 months, 6 months and 12 months
Changes in serum gamma glutamyltranspeptidase levels (mmol/L)		3 months, 6 months and 12 months
Changes in controlled attenuation parameter(dB/m)	Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）	3 months, 6 months and 12 months
Changes in Changes in liver fibrosis	Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）	3 months, 6 months and 12 months
Changes in Epworth sleepiness scores（ESS)	The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.	3 months, 6 months and 12 months
Changes in depressive symptoms	Depressive symptoms will be assessed by Patient Health Questionnaire-9 (PHQ-9) algorithm scoring method. The range of PHQ-9 is from 0 to 27 and higher scores mean worse outcome.	3 months, 6 months and 12 months
Changes in HbA1c level (%)		Time Frame: 3 months, 6 months and 12 months
Incidence of impaired glucose regulation progressing to diabetes	Incidence of impaired glucose regulation progressing to diabetes	12 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): August 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Overweight; Obesity; Intermittent Fasting
• Other Study ID Numbers: KYH2019-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No