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

NCT06754306 | Completed

• 1 other identifier: SJUPN-2024-009-HY1-KS2
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dietary Intervention; Randomized Controlled Trial; Intermittent Fasting; Caloric Restriction

Outcome Measures

Primary Outcomes (1)

• Change in Visceral Fat Area over the Course of the Dietary Intervention

  Visceral fat area will be measured using the InBody770 bioelectrical impedance analysis (BIA) device.

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32

Secondary Outcomes (31)

• Change in Body Weight over the Course of the Dietary Intervention

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32

• Change in Waist Circumference over the Course of the Dietary Intervention

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32

• Change in Hip Circumference over the Course of the Dietary Intervention

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32

• Body height at Baseline

  Baseline only

• Change in Body Mass Index (BMI) over the Course of the Dietary Intervention

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32

Study Arms (7)

Balanced diet group

EXPERIMENTAL

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

Other: Balanced diet (100% energy)

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

EXPERIMENTAL

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 (100% energy)

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

EXPERIMENTAL

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

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

Alternate-day fasting group (75% energy)

EXPERIMENTAL

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

Other: Alternate-day fasting group (75% energy)

5+2 intermittent fasting group (75% energy)

EXPERIMENTAL

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

Other: 5+2 intermittent fasting group (75% energy)

Low-calorie diet group (75% energy)

EXPERIMENTAL

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

Other: Low-calorie diet group (75% energy)

Very low-calorie diet group (45% energy)

EXPERIMENTAL

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

Other: Very low-calorie diet group (45% energy)

Interventions

Balanced diet (100% energy) OTHER

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

Balanced diet group

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

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

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

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

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

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

Alternate-day fasting group (75% energy) OTHER

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

Alternate-day fasting group (75% energy)

5+2 intermittent fasting group (75% energy) OTHER

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

5+2 intermittent fasting group (75% energy)

Low-calorie diet group (75% energy) OTHER

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

Low-calorie diet group (75% energy)

Very low-calorie diet group (45% energy) OTHER

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

Very low-calorie diet group (45% energy)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18-35 years.
• BMI between 18.5 and 23.9.
• Willing to voluntarily sign the informed consent form and comply with group assignments and intervention protocols.

You may not qualify if:

• Diagnosed with metabolic diseases such as hypertension, diabetes, or dyslipidemia.
• Diagnosed with uncontrolled psychiatric disorders.
• Diagnosed with severe underlying diseases, such as renal failure, heart failure, or cancer.
• Currently taking medications that may affect study outcomes (e.g., antihypertensive, antidiabetic, or lipid-lowering drugs).
• Women in the perimenopausal stage or with irregular menstrual cycles.
• Pregnant women.
• Current smokers.
• Unstable weight within the past three months (fluctuations exceeding 4 kg).

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• School of Public Health, Shanghai Jiao Tong University: collaborator
• Huangpu District Center for Disease Control and Prevention, Shanghai: collaborator

Study Sites (1)

School of Public Health, Shanghai Jiao Tong University, Shanghai, China

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Hui Wang, PhD

  School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, and Doctor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: August 25, 2024
• Primary Completion: June 9, 2025
• Study Completion: June 9, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)