Clinical trial NCT06018415: Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
Official title: Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Overweight and Obesity
Time Restricted Eating
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome


Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 65 years
2. Body mass index (BMI): 24.0-40.0 kg/m2
3. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):

   1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
   2. Elevated triglyceride (TG) (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
   3. Reduced high-density lipoprotein cholesterol (HDL-c) (use of medications for reduced HDL-c is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females.
   4. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure (DBP) ≥ 85 mmHg.
   5. Elevated fasting blood glucose (FBG) (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).

Exclusion Criteria:

1. Unstable weight (change \> 10% current body weight) for 3 months prior to the study
2. Pregnant or breast-feeding
3. Night shift workers
4. History of major diseases or related diseases, such as cancer, inflammatory disease, chronic obstructive pulmonary disease and major adverse cardiovascular event
5. Active viral hepatitis, acquired immune deficiency syndrome, syphilis and other sexually transmitted diseases, tuberculosis and other infectious diseases
6. Being treated with antibiotics or corticosteroids
7. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite
8. The researcher deemed it inappropriate to participate in the experimenter.

Primary outcomes:
measure: Changes in body weight
timeFrame: 0-week; 6-week and 12-week
measure: Changes in abdominal fat area
timeFrame: 0-week; 6-week and 12-week
Secondary outcomes:
measure: Changes in body composition ( body fat mass)
timeFrame: 0-week; 6-week and 12-week
measure: Changes in body composition (body muscle mass)
timeFrame: 0-week; 6-week and 12-week
measure: Changes in glycemic control, haemoglobin A1c (HbA1c)
timeFrame: 0-week; 6-week and 12-week
measure: Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)
timeFrame: 0-week; 6-week and 12-week
measure: Changes in uric acid (UA)
timeFrame: 0-week; 6-week and 12-week
measure: Changes in blood pressure.
timeFrame: 0-week; 6-week and 12-week
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Bingyin Shi
role: STUDY_CHAIR
References: