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

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

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

Study Overview

• Status: Recruiting
• Conditions: Impaired Glucose Regulation; Time-Restricted Feeding; Overweight/Obese
• Intervention / Treatment: Behavioral: Time Restricted Feeding(TRF); Behavioral: Reduced Calorie Diet (RCD)

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Changqin Liu, MD&PhD; Phone Number: +8613376986106 +8613376986106; Email: liuchangqin@xmu.edu.cn
• Study Contact Backup: Name: Xin zheng, MD; Phone Number: +8618705929102; Email: 88126386@qq.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Changqin Liu, MD; Phone Number: +86-133 7698 6106; Email: liuchangqin@xmu.edu.cn

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
Experimental: TRF; Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.	Behavioral: Time Restricted Feeding(TRF); 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 feeding time.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in HbA1c level (%)	3 months, 6 months and 12 months
Change in serum fasting insulin levels (pmol/L)	3 months, 6 months and 12 months
Incidence of regression to normoglycaemia among the studied population	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): January 31, 2024

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): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• 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