Energy MetabolismNCT06754306
Dynamic Effects of Different Dietary Interventions on Visceral Fat and Biochemical Markers
A study testing Balanced diet (100% energy), 16+8 time-restricted eating group (100% energy) and 16+8 time-restricted eating group (75% energy) in people with Energy Metabolism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism
- What is being tested?
- Balanced diet (100% energy), 16+8 time-restricted eating group (100% energy) and 16+8 time-restricted eating group (75% energy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2024to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
School of Public Health, Shanghai Jiao Tong University, Shanghai, China
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Randomized Controlled Trial on the Dynamic Effects of Different Dietary Interventions on Visceral Fat and Other Biochemical Markers
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.
Read more
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.
Read the detailed description
This study is a randomized clinical trial (RCT) designed to investigate the effects of different dietary interventions on visceral fat, body composition, and various biochemical indicators. The study will also incorporate multi-omics analyses to explore the dynamic biological mechanisms underlying these effects.
Study Background The increasing burden of obesity and chronic diseases has raised global concerns about effective dietary strategies. Recent dietary approaches, such as intermittent fasting (e.g., 16:8, alternate-day fasting, and 5:2 fasting) and continuous caloric restriction, have shown potential benefits in weight management and metabolic health. However, there is a lack of systematic comparisons between these dietary interventions and insufficient understanding of their dynamic biological effects.
This study aims to compare the short-term impacts of various dietary interventions and identify the biological mechanisms influencing visceral fat and metabolic changes. Multi-omics analyses will include proteomics, metabolomics, metagenomics, DNA methylation etc. to provide a comprehensive understanding of these effects.
Study Design
This RCT will recruit 84 healthy adults (12 participants per group), aged 18-35 years, with a normal BMI (18.5-23.9). Participants will be randomly assigned to one of seven groups:
Balanced diet group: Daily intake of 100% energy requirements, adjusted individually based on each participant's basal metabolic rate (BMR) and activity level.
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.
16+8 time-restricted eating group (75% energy): Participants will consume 75% of their energy requirements within the 8-hour eating window.
Alternate-day fasting group: Participants alternate between "feeding days" (125% energy requirements) and "fasting days" (25% energy requirements).
5+2 intermittent fasting group: Participants consume 95% energy requirements for 5 consecutive days and 25% energy requirements for 2 fasting days.
Low-calorie diet group (75% energy): Participants will reduce daily caloric intake to 75% of energy requirements, consumed evenly across three meals.
Very low-calorie diet group (45% energy): Participants will reduce daily caloric intake to 45% of energy requirements (~800 kcal/day).
The study will span 33 weeks and include three phases:
Baseline phase (1 week): Participants consume their usual diet, and baseline measurements are taken.
Intervention phase (4 weeks): Participants adhere to their assigned dietary intervention.
Recovery phase (28 weeks): Participants return to their usual diet. Participants will be monitored closely throughout the study to ensure adherence to the intervention and the stability of other lifestyle factors (e.g., physical activity).
Outcome Measures Primary outcome: Changes in visceral fat area. Secondary outcomes: Changes in body composition (waist circumference, BMI, body fat percentage), cardiovascular indicators (e.g., blood pressure, cholesterol levels), inflammation markers (e.g., IL-6, IL-8), and liver/kidney function.
Biological samples (blood, urine, and feces) will be collected at baseline, weekly during the intervention phase, and at weeks 5, 8 and 32 of the recovery phase. Samples will be analyzed using multi-omics techniques, including proteomics, metabolomics, metagenomics, DNA methylation, etc. to identify dynamic biological changes associated with the dietary interventions.
Data Collection and Analysis Participants' data will include questionnaires, anthropometric measurements, biochemical tests, and multi-omics results. Blood samples, urine samples, and fecal samples (2 will be collected at each time point. Data will be analyzed to compare group differences in primary and secondary outcomes, with additional exploration of the underlying biological mechanisms through omics analyses.
Ethical Considerations The study has received ethical approval from the Institutional Review Board for Public Health and Nursing Research, Shanghai Jiao Tong University School of Medicine. Informed consent will be obtained from all participants before enrollment. Participant privacy and data confidentiality will be strictly maintained throughout the study.
Significance This study will provide a comparative analysis of different dietary interventions and their impacts on visceral fat and metabolic health. The inclusion of dynamic multi-omics analyses will offer new insights into the biological mechanisms underlying these effects. The findings will contribute valuable evidence for the development of dietary guidelines and public health strategies for weight management and chronic disease prevention.
- Conditions
- Energy Metabolism
- Being tested
- Balanced diet (100% energy), 16+8 time-restricted eating group (100% energy), 16+8 time-restricted eating group (75% energy), Alternate-day fasting group (75% energy), 5+2 intermittent fasting group (75% energy)
- Keywords
- Dietary Intervention, Randomized Controlled Trial, Intermittent Fasting, Caloric Restriction
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 (75% energy)Other
Participants will consume 75% of their energy requirements within the 8-hour eating window.
Alternate-day fasting group (75% energy)Other
Participants alternate between "feeding days" (125% energy requirements) and "fasting days" (25% energy requirements).
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.
Low-calorie diet group (75% energy)Other
Participants will reduce daily caloric intake to 75% of energy requirements, consumed evenly across three meals.
Very low-calorie diet group (45% energy)Other
Participants will reduce daily caloric intake to 45% of energy requirements (~800 kcal/day)
| Study group | Role | What they receive |
|---|---|---|
| Balanced diet group | Experimental | Daily intake of 100% energy requirements, adjusted individually based on each participant's basal metabolic rate (BMR) and activity level. Receives: 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. Receives: 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. Receives: 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). Receives: 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. Receives: 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. Receives: 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) Receives: Other: Very low-calorie diet group (45% energy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Body height at Baseline
Measured: Baseline only
Change in Body Mass Index (BMI) over the Course of the Dietary Intervention
Body Weight and height will be used to calculate BMI in kg/m^2.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Body Fat Mass over the Course of the Dietary Intervention
Body fat mass will be measured using the InBody770 bioelectrical impedance analysis (BIA) device.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Percent Body Fat Mass over the Course of the Dietary Intervention
Percent body fat will be measured using the InBody770 bioelectrical impedance analysis (BIA) device.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Skeletal Muscle Mass over the Course of the Dietary Intervention
Skeletal muscle mass will be measured using the InBody770 bioelectrical impedance analysis (BIA) device.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Visceral Fat Level over the Course of the Dietary Intervention
Visceral fat level will be measured using the InBody770 bioelectrical impedance analysis (BIA) device.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Basal Metabolic Rate over the Course of the Dietary Intervention
Basal metabolic rate will be measured using the metabolic cart.
Measured: Baseline, and Week 4
Change in Blood Pressure over the Course of the Dietary Intervention
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Blood lipids over the Course of the Dietary Intervention
Lipid profile measurements will include the following biomarkers: Apolipoprotein B (Apo-B), Lipoprotein(a) [LPa], Apolipoprotein A1 (Apo-A1), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Total Cholesterol (Tch).
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Blood glucose over the Course of the Dietary Intervention
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Inflammation Markers over the Course of the Dietary Intervention
Inflammatory biomarkers will be measured to assess participants' systemic inflammatory status and immune response. The panel of biomarkers includes interleukins (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17A), interferon-gamma (IFN-γ), tumor necrosis factors (TNF-α, TNF-β) and CRP.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Liver Function Indicators over the Course of the Dietary Intervention
Liver function will be assessed through blood biochemical analysis. Specific indicators include alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin (ALB), total protein (TP), direct bilirubin (D-BIL), and total bilirubin (T-BIL).
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Kidney Function Indicators over the Course of the Dietary Intervention
Kidney function will be assessed through blood biochemical analysis. Specific indicators include serum creatinine (SCr) and blood urea nitrogen (BUN).
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Genetic Analysis Using ASA Chip
Measured: Baseline Only
Dynamic Changes in Multi-Omics Profiles (Methylation Chip, Blood Transcriptomics, Proteomics, Metabolomics, Fecal Metagenomics, and Fecal Metabolomics) over the Course of the Dietary Intervention
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Urinalysis Indicators over the Course of the Dietary Intervention
Urinalysis will be performed to assess general kidney function, metabolic status, and potential abnormalities in urinary composition. The panel of indicators includes leukocyte esterase, specific gravity, bilirubin, urobilinogen, protein, pH, glucose, ketones, nitrites, occult blood, and urine color.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Mental Health Status Measured by PHQ-9 over the Course of the Dietary Intervention
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. The PHQ-9 is a validated questionnaire with 9 items, scored on a scale from 0 to 3 for each item, resulting in a total score ranging from 0 to 27. Higher scores indicate worse mental health outcomes, with higher levels of depressive symptoms.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Mental Health Status Measured by SAS over the Course of the Dietary Intervention
The Self-Rating Anxiety Scale (SAS) will be used to assess anxiety symptoms. The SAS consists of 20 items, with each item scored on a scale from 1 to 4, and the total raw score is converted to a standard score ranging from 25 to 100. Higher scores indicate worse mental health outcomes, with more severe anxiety symptoms.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Sleeping Status Measured by PSQI over the Course of the Dietary Intervention
The Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate participants' sleep quality. The PSQI is a validated questionnaire with 19 self-rated items, generating 7 component scores (e.g., subjective sleep quality, sleep latency, sleep duration) that are combined into a global score. The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline, Week 4, Week 8, and Week 32
Adverse Events Reporting over the Dietary Intervention Course
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Continuous Glucose Monitoring Metrics over the Dietary Intervention Course
Dynamic tracking of glucose levels using a continuous glucose monitoring device to evaluate glycemic responses to dietary interventions.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Sleep Metrics Measured by Smart Ring over the Dietary Intervention Course
Sleep metrics, including duration, sleep stages, and overall sleep quality, will be continuously monitored using a smart ring. Measurements will provide insights into sleep patterns and changes over the study period.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Physical Activity Metrics Measured by Smart Ring over the Dietary Intervention Course
Physical activity metrics, including step count, activity duration, and intensity, will be continuously tracked using a smart ring to assess participants' activity levels throughout the study.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Blood Oxygen Levels (SpO₂) Measured by Smart Ring over the Dietary Intervention Course
Real-time blood oxygen saturation (SpO₂) will be continuously measured using a smart ring to monitor oxygen levels and detect any variations during the study.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Heart Rate Metrics Measured by Smart Ring over the Dietary Intervention Course
Heart rate metrics, including resting heart rate and activity-related heart rate, will be continuously monitored using a smart ring to assess cardiovascular response and changes over time.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Respiration Rate Measured by Smart Ring over the Dietary Intervention Course
Respiration rate will be continuously tracked using wearable devices, providing data on participants' breathing patterns and changes over the study period.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Stress Levels Measured by Smart Ring over the Dietary Intervention Course
Physiological stress indicators, such as heart rate variability (HRV) and other metrics, will be monitored using wearable devices to assess changes in participants' stress levels over the course of the study.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Changes in Blood Pressure Measured by Smart Watch over the Dietary Intervention Course
Blood pressure variations will be continuously measured using a smartwatch to monitor changes and trends in participants' cardiovascular health throughout the study period.
Measured: Continuously Throughout the Study (Baseline to Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start25 Aug 2024
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- School of Public Health, Shanghai Jiao Tong University, Huangpu District Center for Disease Control and Prevention, Shanghai
- Responsible party
- Principal investigator, Hui Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hui Wang, PhD, Principal investigator, School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754306
- Sponsor's protocol ID
- SJUPN-2024-009-HY1-KS2
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We acknowledge the importance of data sharing for scientific advancement; however, due to the absence of a predefined data sharing mechanism in our study design and the need to prioritize participant confidentiality, we currently do not have a plan to share individual participant data (IPD). We remain open to exploring future opportunities to share aggregate data or collaborate with interested researchers within an ethically appropriate framework.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Dynamic Effects of Different Dietary Interventions on Visceral Fat and Other Biochemical Markers
- ClinicalTrials.gov ID
- NCT06754306
- Acronym / sponsor ID
- SJUPN-2024-009-HY1-KS2
- Conditions
- Energy Metabolism
- Keywords
- Dietary Intervention, Randomized Controlled Trial, Intermittent Fasting, Caloric Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- School of Public Health, Shanghai Jiao Tong University, Huangpu District Center for Disease Control and Prevention, Shanghai
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized clinical trial (RCT) designed to investigate the effects of different dietary interventions on visceral fat, body composition, and various biochemical indicators. The study will also incorporate multi-omics analyses to explore the dynamic biological mechanisms underlying these effects.
Study Background The increasing burden of obesity and chronic diseases has raised global concerns about effective dietary strategies. Recent dietary approaches, such as intermittent fasting (e.g., 16:8, alternate-day fasting, and 5:2 fasting) and continuous caloric restriction, have shown potential benefits in weight management and metabolic health. However, there is a lack of systematic comparisons between these dietary interventions and insufficient understanding of their dynamic biological effects.
This study aims to compare the short-term impacts of various dietary interventions and identify the biological mechanisms influencing visceral fat and metabolic changes. Multi-omics analyses will include proteomics, metabolomics, metagenomics, DNA methylation etc. to provide a comprehensive understanding of these effects.
Study Design
This RCT will recruit 84 healthy adults (12 participants per group), aged 18-35 years, with a normal BMI (18.5-23.9). Participants will be randomly assigned to one of seven groups:
Balanced diet group: Daily intake of 100% energy requirements, adjusted individually based on each participant's basal metabolic rate (BMR) and activity level.
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.
16+8 time-restricted eating group (75% energy): Participants will consume 75% of their energy requirements within the 8-hour eating window.
Alternate-day fasting group: Participants alternate between "feeding days" (125% energy requirements) and "fasting days" (25% energy requirements).
5+2 intermittent fasting group: Participants consume 95% energy requirements for 5 consecutive days and 25% energy requirements for 2 fasting days.
Low-calorie diet group (75% energy): Participants will reduce daily caloric intake to 75% of energy requirements, consumed evenly across three meals.
Very low-calorie diet group (45% energy): Participants will reduce daily caloric intake to 45% of energy requirements (~800 kcal/day).
The study will span 33 weeks and include three phases:
Baseline phase (1 week): Participants consume their usual diet, and baseline measurements are taken.
Intervention phase (4 weeks): Participants adhere to their assigned dietary intervention.
Recovery phase (28 weeks): Participants return to their usual diet. Participants will be monitored closely throughout the study to ensure adherence to the intervention and the stability of other lifestyle factors (e.g., physical activity).
Outcome Measures Primary outcome: Changes in visceral fat area. Secondary outcomes: Changes in body composition (waist circumference, BMI, body fat percentage), cardiovascular indicators (e.g., blood pressure, cholesterol levels), inflammation markers (e.g., IL-6, IL-8), and liver/kidney function.
Biological samples (blood, urine, and feces) will be collected at baseline, weekly during the intervention phase, and at weeks 5, 8 and 32 of the recovery phase. Samples will be analyzed using multi-omics techniques, including proteomics, metabolomics, metagenomics, DNA methylation, etc. to identify dynamic biological changes associated with the dietary interventions.
Data Collection and Analysis Participants' data will include questionnaires, anthropometric measurements, biochemical tests, and multi-omics results. Blood samples, urine samples, and fecal samples (2 will be collected at each time point. Data will be analyzed to compare group differences in primary and secondary outcomes, with additional exploration of the underlying biological mechanisms through omics analyses.
Ethical Considerations The study has received ethical approval from the Institutional Review Board for Public Health and Nursing Research, Shanghai Jiao Tong University School of Medicine. Informed consent will be obtained from all participants before enrollment. Participant privacy and data confidentiality will be strictly maintained throughout the study.
Significance This study will provide a comparative analysis of different dietary interventions and their impacts on visceral fat and metabolic health. The inclusion of dynamic multi-omics analyses will offer new insights into the biological mechanisms underlying these effects. The findings will contribute valuable evidence for the development of dietary guidelines and public health strategies for weight management and chronic disease prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Balanced diet group | Experimental | 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. |
| 16+8 time-restricted eating group (100% energy) | Experimental | 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. |
| 16+8 time-restricted eating group (75% energy) | Experimental | Other: 16+8 time-restricted eating group (75% energy)Participants will consume 75% of their energy requirements within the 8-hour eating window. |
| Alternate-day fasting group (75% energy) | Experimental | Other: Alternate-day fasting group (75% energy)Participants alternate between "feeding days" (125% energy requirements) and "fasting days" (25% energy requirements). |
| 5+2 intermittent fasting group (75% energy) | Experimental | 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. |
| Low-calorie diet group (75% energy) | Experimental | Other: Low-calorie diet group (75% energy)Participants will reduce daily caloric intake to 75% of energy requirements, consumed evenly across three meals. |
| Very low-calorie diet group (45% energy) | Experimental | Other: Very low-calorie diet group (45% energy)Participants will reduce daily caloric intake to 45% of energy requirements (~800 kcal/day) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Balanced diet group |
| 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 (100% energy) |
| 16+8 time-restricted eating group (75% energy)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)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)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)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)Participants will reduce daily caloric intake to 45% of energy requirements (~800 kcal/day) | Other | Very low-calorie diet group (45% energy) |
Primary outcome
Change in Visceral Fat Area over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Visceral fat area will be measured using the InBody770 bioelectrical impedance analysis (BIA) device.
31 secondary outcomes
Change in Body Weight over the Course of the Dietary Intervention
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Body height at Baseline
Time frame: Baseline only
Change in Body Mass Index (BMI) over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Body Fat Mass over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Percent Body Fat Mass over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Skeletal Muscle Mass over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Visceral Fat Level over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Basal Metabolic Rate over the Course of the Dietary Intervention
Time frame: Baseline, and Week 4
Change in Blood Pressure over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Blood lipids over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Blood glucose over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Inflammation Markers over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Liver Function Indicators over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Change in Kidney Function Indicators over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Genetic Analysis Using ASA Chip
Time frame: Baseline Only
Dynamic Changes in Multi-Omics Profiles (Methylation Chip, Blood Transcriptomics, Proteomics, Metabolomics, Fecal Metagenomics, and Fecal Metabolomics) over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Urinalysis Indicators over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Mental Health Status Measured by PHQ-9 over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Mental Health Status Measured by SAS over the Course of the Dietary Intervention
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Changes in Sleeping Status Measured by PSQI over the Course of the Dietary Intervention
Time frame: Baseline, Week 4, Week 8, and Week 32
Adverse Events Reporting over the Dietary Intervention Course
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32
Continuous Glucose Monitoring Metrics over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Sleep Metrics Measured by Smart Ring over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Physical Activity Metrics Measured by Smart Ring over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Blood Oxygen Levels (SpO₂) Measured by Smart Ring over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Heart Rate Metrics Measured by Smart Ring over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Respiration Rate Measured by Smart Ring over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Stress Levels Measured by Smart Ring over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Changes in Blood Pressure Measured by Smart Watch over the Dietary Intervention Course
Time frame: Continuously Throughout the Study (Baseline to Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. We acknowledge the importance of data sharing for scientific advancement; however, due to the absence of a predefined data sharing mechanism in our study design and the need to prioritize participant confidentiality, we currently do not have a plan to share individual participant data (IPD). We remain open to exploring future opportunities to share aggregate data or collaborate with interested researchers within an ethically appropriate framework.
Related trials for Energy Metabolism
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Recruiting
Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Wang, PhD principal investigator
School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced diet (100% energy), 16+8 time-restricted eating group (100% energy) and 16+8 time-restricted eating group (75% energy) in people with Energy Metabolism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Fat Area over the Course of the Dietary Intervention (time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, and Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.