Dynamic Effects of Different Dietary Interventions on Visceral Fat and Biochemical Markers

Summary

This randomized clinical trial aims to evaluate the dynamic effects of various dietary interventions on visceral fat and biochemical markers among healthy adults. Participants aged 18-35 years with a normal body mass index (BMI 18.5-23.9) will be recruited from the community. Exclusion criteria include metabolic diseases, unstable weight, medication use, or pregnancy.

Participants will be randomly assigned to one of seven groups: 1) balanced diet (100% energy), 2) time-restricted eating (16+8, 100% energy), 3) time-restricted eating (16+8, 75% energy), 4) alternate-day fasting (75% energy), 5) 5+2 fasting (75% energy), 6) low-calorie diet (75% energy), and 7) very low-calorie diet (45% energy). The intervention consists of a 1-week baseline phase, a 4-week dietary intervention phase, and a 28-week recovery phase.

Primary outcomes include changes in visceral fat area, while secondary outcomes include body composition, cardiovascular health indicators (e.g., blood pressure, cholesterol), inflammation markers, and liver/kidney function. Biological samples (blood, urine, and feces) will be collected at multiple time points to facilitate multi-omics analyses, including proteomics, metabolomics, metagenomics, and DNA methylation.

The study aims to compare the short-term effects of different dietary interventions and explore underlying biological mechanisms. Findings will provide evidence for public health policies and dietary guidelines related to weight management and metabolic health.

Conditions

• Energy Metabolism

Interventions

OTHER

Balanced diet (100% energy)

Daily intake of 100% energy requirements, adjusted individually based on each participant's basal metabolic rate (BMR) and activity level.

OTHER

16+8 time-restricted eating group (100% energy)

Participants will consume 100% energy within an 8-hour eating window and fast for the remaining 16 hours.

OTHER

16+8 time-restricted eating group (75% energy)

Participants will consume 75% of their energy requirements within the 8-hour eating window.

OTHER

Alternate-day fasting group (75% energy)

Participants alternate between "feeding days" (125% energy requirements) and "fasting days" (25% energy requirements).

OTHER

5+2 intermittent fasting group (75% energy)

Participants consume 95% energy requirements for 5 consecutive days and 25% energy requirements for 2 fasting days.

OTHER

Low-calorie diet group (75% energy)

Participants will reduce daily caloric intake to 75% of energy requirements, consumed evenly across three meals.

OTHER

Very low-calorie diet group (45% energy)

Participants will reduce daily caloric intake to 45% of energy requirements (\~800 kcal/day)

Sponsors & Collaborators

• School of Public Health, Shanghai Jiao Tong University

  collaborator UNKNOWN

• Huangpu District Center for Disease Control and Prevention, Shanghai

  collaborator UNKNOWN

• Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Hui Wang, PhD · School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-08-25

Primary Completion

2025-06-09

Completion

2025-06-09

Countries

• China

Study Locations