Liver FatNCT06441409
Effect of Lifestyle Intervention on Mobilization of Fat Storage and Iron Deposition in Obesity
A study testing Lifestyle intervention in people with Liver Fat and Fertility Disorders, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if calorie-restricted balanced diet could uniquely influence various fat storage pools and iron deposition and explore the relationships between fat or iron deposition loss in specific locations and glucose metabolism. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fat, Fertility Disorders, Life Style, Healthy
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 28 Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years
- have a BMI greater than 28.0 kg/m2
- exhibit abdominal obesity, defined as a waist circumference of at least 90 cm for men and 85 cm for women
- willing to undergo a 6-month lifestyle intervention
Who cannot join
- For newly diagnosed patients with type 2 diabetes: those with fasting blood glucose ≥ 11.1 mmol/L, random blood glucose ≥ 16.7 mmol/L, or HbA1c ≥ 9.0%, or those exhibiting significant hyperglycemic symptoms, who need to start antidiabetic medication treatment immediately;
- a prior history of pancreatic diseases;
- combination of drug-induced hepatitis, autoimmune hepatitis, and viral hepatitis;
- with a definitive diagnosis of diabetes who have already started medication treatment;
- severe complications from type 2 diabetes or other significant diseases;
- usage of drugs affecting body weight, insulin sensitivity, or metabolic-associated fatty liver disease in the past three months (such as insulin, glucocorticoids, thiazolidinediones, metformin, SGLT-2 inhibitors, or GLP-1 receptor agonists);
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- with malignant tumors;
- acute or chronic infection;
- with elevated transaminase levels of unknown cause;
- hemochromatosis;
- with iron deficiency anemia who are receiving iron supplementation;
- who have donated blood or received a transfusion within the past six months;
- who have experienced cardiovascular events within the past six months;
- with acute or chronic blood loss;
- alcohol dependence, defined as ethanol intake exceeding 140 g/week for men and 70 g/week for women；
- pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Effect of Calorie-restricted Balanced Diet on Mobilization of Fat Storage Pools and Iron Deposition in Individuals With Obesity
The goal of this clinical trial is to learn if calorie-restricted balanced diet could uniquely influence various fat storage pools and iron deposition and explore the relationships between fat or iron deposition loss in specific locations and glucose metabolism. The main questions it aims to answer are:
After lifestyle intervention, which part of the body shows the fastest fat mobilization? Which part shows the slowest fat mobilization? Which area's fat mobilization is most related to the alleviation of glucose metabolism? Is there a relationship between the fat deposition in organs and the iron deposition in organs?
Read more
Researchers will compare the liver fat, pancreatic fat, visceral fat, subscutaneous fat, liver and pancrease iron depositon after lifestyle intervention using self pre-and post-control .
Participants will:
Receive the lifestyle intervention in outpatient. Visit the clinic once after 6 months for checkups and tests. Keep a diary of their diet.
Read the detailed description
Fat mobilization status is assessed using magnetic resonance, while the relief of glucose metabolism is determined based on the results of the OGTT before and after life style intervention.
- Conditions
- Liver Fat, Fertility Disorders, Life Style, Healthy, Glucose Metabolism Disorders (Including Diabetes Mellitus)
- Being tested
- Lifestyle intervention
- Medical subject headings
- Fatty Liver, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Patients were intervened with lifestyle only and returned to clinic for tests in 6 months.
Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Experimental | Patients were intervened with lifestyle only and returned to clinic for tests in 6 months.
Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day. Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The site-specific fat mobilization after 6 months' lifestyle intervention.
Defined by percentage MRI-based fat loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).
Measured: After 6 months intervention, patients were return to hospital for MRI analysis.
The site-specific iron deposition mobilization after 6 months' lifestyle intervention.
Defined by percentage MRI-based organ iron content loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).
Measured: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
Secondary outcomes (1)
The correlation between liver fat and liver iron.
Categorical variables were summarized as numbers (percentages), continuous variables with normal distributions as means (SDs), and continuous variables with non-normal distributions as medians (interquartile ranges [IQRs]). Treatment-induced changes were tested by the paired t test and Wilcoxon signed-rank test, as appropriate. The unpaired t test, Mann-Whitney U test, and Kruskal-Wallis test were used for group comparisons. Correlations between site-specific fat mobilization and clinical outcomes were investigated by calculating Pearson correlation coefficients and Pearson partial correlation coefficients. Two-sided P < 0.05 was considered statistically significant. Statistical analyses were performed using R software version 4.1.2 (http://www.r-project.org/).
Measured: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Apr 2024
- Primary completion20 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FatStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients were intervened with lifestyle only.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Jin, Study chair, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441409
- Sponsor's protocol ID
- 22218
- Other IDs
- No. 2022JJ40749
- Status last verified
- May 2025
- First submitted
- 15 Apr 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calorie-restricted Balanced Diet on Mobilization of Fat Storage Pools and Iron Deposition in Individuals With Obesity
- ClinicalTrials.gov ID
- NCT06441409
- Acronym / sponsor ID
- 22218
- Conditions
- Liver Fat, Fertility Disorders, Life Style, Healthy, Glucose Metabolism Disorders (Including Diabetes Mellitus)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 4 Jun 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.
The goal of this clinical trial is to learn if calorie-restricted balanced diet could uniquely influence various fat storage pools and iron deposition and explore the relationships between fat or iron deposition loss in specific locations and glucose metabolism. The main questions it aims to answer are:
After lifestyle intervention, which part of the body shows the fastest fat mobilization? Which part shows the slowest fat mobilization? Which area's fat mobilization is most related to the alleviation of glucose metabolism? Is there a relationship between the fat deposition in organs and the iron deposition in organs?
Researchers will compare the liver fat, pancreatic fat, visceral fat, subscutaneous fat, liver and pancrease iron depositon after lifestyle intervention using self pre-and post-control .
Participants will:
Receive the lifestyle intervention in outpatient. Visit the clinic once after 6 months for checkups and tests. Keep a diary of their diet.
Detailed description
Fat mobilization status is assessed using magnetic resonance, while the relief of glucose metabolism is determined based on the results of the OGTT before and after life style intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients were intervened with lifestyle only.
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: Lifestyle interventionPatients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 70 years
- have a BMI greater than 28.0 kg/m2
- exhibit abdominal obesity, defined as a waist circumference of at least 90 cm for men and 85 cm for women
- willing to undergo a 6-month lifestyle intervention
Key exclusion criteria (16 listed)
- For newly diagnosed patients with type 2 diabetes: those with fasting blood glucose ≥ 11.1 mmol/L, random blood glucose ≥ 16.7 mmol/L, or HbA1c ≥ 9.0%, or those exhibiting significant hyperglycemic symptoms, who need to start antidiabetic medication treatment immediately;
- a prior history of pancreatic diseases;
- combination of drug-induced hepatitis, autoimmune hepatitis, and viral hepatitis;
- with a definitive diagnosis of diabetes who have already started medication treatment;
- severe complications from type 2 diabetes or other significant diseases;
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 |
|---|---|---|
| Lifestyle interventionPatients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day. | Behavioural | lifestyle intervention |
Primary outcome
The site-specific fat mobilization after 6 months' lifestyle intervention.
Time frame: After 6 months intervention, patients were return to hospital for MRI analysis.
Defined by percentage MRI-based fat loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).
The site-specific iron deposition mobilization after 6 months' lifestyle intervention.
Time frame: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
Defined by percentage MRI-based organ iron content loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).
1 secondary outcome
The correlation between liver fat and liver iron.
Time frame: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
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 7 Aug 2025.
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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.
Ping Jin study chair
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Liver Fat and Fertility Disorders, run by The Third Xiangya Hospital of Central South University 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 4 inclusion and 16 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 7 Aug 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?
The site-specific fat mobilization after 6 months' lifestyle intervention. (time frame: After 6 months intervention, patients were return to hospital for MRI analysis.). The study lists 2 primary outcomes in all. 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 7 Aug 2025.