NCT06018415CompletedNot Applicable
Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome
First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country103 target enrollmentStarted: May 7, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Changes in abdominal fat area
Study Overview
Brief Summary
Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 18 to 65 years
- •Body mass index (BMI): 24.0-40.0 kg/m2
- •Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):
- •Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
- •Elevated triglyceride (TG) (use of lipid-lowering medication is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
- •Reduced high-density lipoprotein cholesterol (HDL-c) (use of lipid-lowering medication is an alternate indicator) < 40 mg/dL (1.0 mmol/L) in males < 50 mg/dL (1.3 mmol/L) in females.
- •Elevated blood pressure (use of antihypertensive medication is an alternate indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure (DBP) ≥ 85 mmHg.
- •Elevated fasting blood glucose (FBG) (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
Exclusion Criteria
- •Unstable weight (change > 10% current body weight) for 3 months prior to the study
- •Pregnant or breast-feeding
- •Night shift workers
- •History of major diseases or related diseases, such as cancer, inflammatory disease, chronic obstructive pulmonary disease and major adverse cardiovascular event
- •Active viral hepatitis, acquired immune deficiency syndrome, syphilis and other sexually transmitted diseases, tuberculosis and other infectious diseases
- •Being treated with antibiotics or corticosteroids
- •Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite
- •The researcher deemed it inappropriate to participate in the experimenter.
Arms & Interventions
Early time-restricted eating (eTRE)
Experimental
The eTRE group is instructed to consume all calories from 7 AM to 3 PM each day and fast from 3 PM to 7 AM
Intervention: Early time-restricted eating (eTRE) (Behavioral)
Late time-restricted eating (lTRE)
Experimental
The lTRE group is instructed toconsume all calories from 11 AM to 7 PM each day and fast from 7 PM to 11 PM
Intervention: Late time-restricted eating (lTRE) (Behavioral)
Outcomes
Primary Outcomes
Changes in abdominal fat area
Time Frame: 0-week; 6-week and 12-week
Abdominal fat area is measured using bioelectrical impedance analysis (OMRON MEDICAL Beijing Co., Ltd. DUALSCAN, HDS-2000) to the nearest 1 cm2.
Changes in body weight
Time Frame: 0-week; 6-week and 12-week
Body weight is assessed at the research center with the participants without shoes and in light clothing using a digital scale (OMRON MEDICAL Beijing Co., Ltd. HNH-318) to the nearest 0.1 kg.
Secondary Outcomes
- Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)(0-week; 6-week and 12-week)
- Changes in uric acid (UA)(0-week; 6-week and 12-week)
- Changes in blood pressure.(0-week; 6-week and 12-week)
- Changes in body composition ( body fat mass)(0-week and 12-week)
- Changes in body composition (body muscle mass)(0-week and 12-week)
- Changes in body composition ( body fat mass)(0-week and 12-week)
- Changes in body composition (body muscle mass)(0-week and 12-week)
- Changes in glycemic control(0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c))
- Changes in hemoglobin A1c (HbA1c)(0-week; 6-week and 12-week (glucose and insulin)0-week and 12-week (HbA1c))
- Changes in total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c)(0-week; 6-week and 12-week)
- Changes in uric acid (UA)(0-week; 6-week and 12-week)
- Changes in blood pressure.(0-week; 6-week and 12-week)
Investigators
Study Sites (1)
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