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Effects of healthy low-carbohydrate diet and 8-hour time-restricted eating on weight improvement and maintenance: RCT

Effects of healthy low-carbohydrate diet and 8-hour time-restricted eating on weight improvement and maintenance: RCT

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110268
Enrollment
Unknown
Registered
2025-10-11
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight

Interventions

High-quality Low-Carbohydrate Diet group (hLCD):Meals are consumed within three conventional meal times, with the last meal finished by 19:00. Macronutrient distribution: 27% carbohydrates, 30% protei
8-hour Time-Restricted Eating group (8-h TRE):>=85% of total daily energy intake is consumed between 07:30 and 15:30
the remaining energy must be consumed between 15:30 and 17:00 on the same day. Macronutrient distribution: 55% carbohydrates, 20% protein, 25% fat. During the intervention, they would be required to c
High-quality LCD + 8-hour Time-Restricted Eating group (hLCD+8-h TRE):>=85% of total daily energy intake is consumed between 07:30 and 15:30
the remaining energy must be consumed between 15:30 and 17:00 on the same day. Macronutrient distribution: 27% carbohydrates, 30% protein, 43% fat. During the intervention, they would be required to c
Control group:Meals are consumed within three conventional meal times, with the last meal finished by 19:00. Macronutrient distribution: 55% carbohydrates, 20% protein, 25% fat. They would receive a g

Sponsors

Guangzhou overseas Chinese hospital, The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Chinese Han nationality, aged 18-50 years 2. BMI 25-35 kg/m^2, or meeting one of the following criteria (1) waist circumference >=90cm(male)or >=85cm(female) (2) waist to hip ratio >=0.5 (3) Body fat >=25%(male)or >=30%(female) (4) Visceral fat area >=80cm^2 3. In the past week, individuals with low-intensity physical activity (METs 1.5–2.9; heart rate <64% of maximum heart rate, where *maximum heart rate = 207 – 0.7 × age [years]*) or daily steps <10,000 were categorized as having low activity levels

Exclusion criteria

Exclusion criteria: 1. Pregnant women, women preparing for pregnancy, and lactating women; 2. Moderate/high-intensity physical activity in the past week or daily step count > 10,000; 3. History of heart, liver, kidney, brain, hematopoietic, immune, or thyroid diseases; malignant tumors; gastrointestinal diseases (e.g., malabsorption or indigestion); or anorexia nervosa; 4. Weight change exceeding 5% in the past three months; irregular eating patterns in the past three months (inconsistent mealtimes); dieting and/or significant lifestyle changes (e.g., daily fasting for 15 hours in the past three months or more than 12 instances of 24-hour fasting in the past year); 5. Use of medications or supplements known to affect body fat, muscle mass, or blood glucose in the past two weeks (e.g., insulin, liraglutide, semaglutide, tirzepatide [GIP/GLP-1 receptor dual agonist], mazdutide, statins, beta-blockers, etc.); 6. Having undergone weight loss surgery in the past three months or planning to undergo such surgery in the next three months; 7. Cognitive or mental impairments that prevent completion of questionnaires; physical disabilities that impair normal walking; 8. Failure to provide informed consent, or other reasons deemed by the investigator as unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Weight;Body composition;Hip circumference;Waist circumference;Visceral Fat Content;

Secondary

MeasureTime frame
GLP-1;INS;Resistin;ALB;Human Peptide YY;AST;Ghrelin;ALT;IL-6;blood lipid profiles;Blood glucose;Leptin;UREA;CRP;ADP;Creatinine;TP;Non-targeted metabolome;Gut microbiota;

Countries

China

Contacts

Public ContactYanbin Ye

Guangzhou overseas Chinese hospital, The First Affiliated Hospital of Jinan University

yanbinye72@163.com+86 20 8758 5387

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026