Sensitivity to Thyroid HormonesNCT04795973
Effects of Intermittent Fasting on Fatty Liver Disease
A study testing 5:2 intermittent fasting in people with Sensitivity to Thyroid Hormones and Metabolic Parameters, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital. All of the following inclusion criteria needed to be met: hepatic fat content (HFC) were upper 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sensitivity to Thyroid Hormones, Metabolic Parameters, in Patients With FLD
- What is being tested?
- 5:2 intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2020to 30 Apr 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations
- age ≥ 18 years
- body mass index (BMI) ≥ 18.5 kg/m2
- stable body weight (change < ± 10% of body weight) during the last 3 months
Who cannot join
- plasma aspartate aminotransferase (AST) and alanine amino-transferase (ALT) levels exceeded 2.5 times of the upper limit of normal
- fasting blood glucose (FBG) levels ≥ 7.0 mmol/L or glycated hemoglobin A1c (HbA1c) ≥ 6.5%
- with type 1 or type 2 diabetes
- with heart disease
- with other hepatic disease (excluding FLD)
- with renal disease
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital. All of the following inclusion criteria needed to be met: hepatic fat content (HFC) were upper 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change < ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
Read the detailed description
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital, Capital Medical University, China, between September 22, 2020 and April 30, 2021. Inclusion criteria were hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change < ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
- Being tested
- 5:2 intermittent fasting
- Keywords
- fatty liver disease, 5:2 intermittent fasting, thyroid hormone sensitivity, insulin sensitivity, weight loss
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5:2 intermittent fastingBehavioural
All subjects received 5:2 IF. They followed a normal diet for 5 days each week and practiced IF for 2 days discontinuously. On normal eating days, women consumed 1200 to 1500 kcal/day and men consumed 1500 to 1800 kcal/day, with macro-nutrient distribution of 45% to 50% carbohydrate, 20% protein, and 30% to 35% fat. They consumed 500 kcal and at least 50 g of protein on a light fasting day. Noncaloric beverages like water and unsweetened tea were allowed without restriction. A nutritionist provided diet guidance and documented any discomfort symptoms throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| 5:2 intermittent fasting | Experimental | All subjects received 5:2 IF. They followed a normal diet for 5 days each week and practiced IF for 2 days discontinuously. On normal eating days, women consumed 1200 to 1500 kcal/day and men consumed 1500 to 1800 kcal/day, with macro-nutrient distribution of 45% to 50% carbohydrate, 20% protein, and 30% to 35% fat. They consumed 500 kcal and at least 50 g of protein on a light fasting day. Noncaloric beverages like water and unsweetened tea were allowed without restriction. A nutritionist provided diet guidance and documented any discomfort symptoms throughout the study. Receives: Behavioral: 5:2 intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer
BMI will be calculated as weight (kg) divided by height squared (m²). Weight will be measured on a calibrated digital scale and height using a stadiometer. Measurements will be taken at baseline and after the 8-week intermittent fasting intervention.
Measured: 8 weeks
TSH Index (TSHI) calculated from serum TSH and FT4 levels
Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be determined using a standardized automated immunoassay. TSH Index will be calculated according to published formulas.
Measured: 8 weeks
Thyrotroph Thyroid Hormone Sensitivity Index (TTSI) calculated from serum TSH and FT4 levels
Fasting blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be measured using a standardized automated immunoassay. TTSI will be calculated according to published formulas.
Measured: 8 weeks
FT3/FT4 ratio calculated from serum FT3 and FT4 levels
Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum FT3 and FT4 concentrations will be measured using a standardized automated immunoassay, and the FT3/FT4 ratio will be calculated as an index of peripheral thyroid hormone conversion efficiency.
Measured: 8 weeks
Changes in metabolic parameters after 8-week IF intervention, measured using blood tests and biochemical assays.
Lipid profile: Total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) will be measured from fasting blood samples.
Glycated hemoglobin (HbA1c, %) will be measured using high-performance liquid chromatography (HPLC). Fasting glucose (mg/dL or mmol/L) will be measured using an enzymatic glucose oxidase method. Fasting insulin (μIU/mL) will be measured using an electrochemiluminescence immunoassay. All blood samples will be collected after an overnight fast at baseline and after the 8-week IF intervention.
Measured: 8 weeks
Changes in abdominal MRI findings (liver fat deposition) after 8-week IF intervention, assessed using magnetic resonance imaging
Abdominal fat distribution and liver fat content will be assessed using magnetic resonance imaging (MRI). Scans will be performed at baseline and after the 8-week IF intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start22 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity to Thyroid HormonesStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Inclusion criteria were hepatic fat content (HFC) \> 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change \< ± 10% of body weight) during the last 3 months.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Wang, Beijing Chao Yang Hospital
- Investigators
- Guang Wang, Principal investigator, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795973
- Sponsor's protocol ID
- 2021-IF-11
- Status last verified
- Sep 2025
- First submitted
- 10 Mar 2021
- Last updated
- 22 Sep 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Fasting on Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04795973
- Acronym / sponsor ID
- 2021-IF-11
- Keywords
- fatty liver disease, 5:2 intermittent fasting, thyroid hormone sensitivity, insulin sensitivity, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 12 Mar 2021 (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.
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital. All of the following inclusion criteria needed to be met: hepatic fat content (HFC) were upper 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change < ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
Detailed description
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital, Capital Medical University, China, between September 22, 2020 and April 30, 2021. Inclusion criteria were hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change < ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inclusion criteria were hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change < ± 10% of body weight) during the last 3 months.
| Arm | Type | Receives |
|---|---|---|
| 5:2 intermittent fasting | Experimental | Behavioral: 5:2 intermittent fastingAll subjects received 5:2 IF. They followed a normal diet for 5 days each week and practiced IF for 2 days discontinuously. On normal eating days, women consumed 1200 to 1500 kcal/day and men consumed 1500 to 1800 kcal/day, with macro-nutrient distribution of 45% to 50% carbohydrate, 20% protein, and 30% to 35% fat. They consumed 500 kcal and at least 50 g of protein on a light fasting day. Noncaloric beverages like water and unsweetened tea were allowed without restriction. A nutritionist provided diet guidance and documented any discomfort symptoms throughout the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations
- age ≥ 18 years
- body mass index (BMI) ≥ 18.5 kg/m2
- stable body weight (change < ± 10% of body weight) during the last 3 months
Key exclusion criteria (6 listed)
- plasma aspartate aminotransferase (AST) and alanine amino-transferase (ALT) levels exceeded 2.5 times of the upper limit of normal
- fasting blood glucose (FBG) levels ≥ 7.0 mmol/L or glycated hemoglobin A1c (HbA1c) ≥ 6.5%
- with type 1 or type 2 diabetes
- with heart disease
- with other hepatic disease (excluding FLD)
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 |
|---|---|---|
| 5:2 intermittent fastingAll subjects received 5:2 IF. They followed a normal diet for 5 days each week and practiced IF for 2 days discontinuously. On normal eating days, women consumed 1200 to 1500 kcal/day and men consumed 1500 to 1800 kcal/day, with macro-nutrient distribution of 45% to 50% carbohydrate, 20% protein, and 30% to 35% fat. They consumed 500 kcal and at least 50 g of protein on a light fasting day. Noncaloric beverages like water and unsweetened tea were allowed without restriction. A nutritionist provided diet guidance and documented any discomfort symptoms throughout the study. | Behavioural | 5:2 intermittent fasting |
Primary outcome
Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer
Time frame: 8 weeks
BMI will be calculated as weight (kg) divided by height squared (m²). Weight will be measured on a calibrated digital scale and height using a stadiometer. Measurements will be taken at baseline and after the 8-week intermittent fasting intervention.
TSH Index (TSHI) calculated from serum TSH and FT4 levels
Time frame: 8 weeks
Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be determined using a standardized automated immunoassay. TSH Index will be calculated according to published formulas.
Thyrotroph Thyroid Hormone Sensitivity Index (TTSI) calculated from serum TSH and FT4 levels
Time frame: 8 weeks
Fasting blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be measured using a standardized automated immunoassay. TTSI will be calculated according to published formulas.
FT3/FT4 ratio calculated from serum FT3 and FT4 levels
Time frame: 8 weeks
Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum FT3 and FT4 concentrations will be measured using a standardized automated immunoassay, and the FT3/FT4 ratio will be calculated as an index of peripheral thyroid hormone conversion efficiency.
Changes in metabolic parameters after 8-week IF intervention, measured using blood tests and biochemical assays.
Time frame: 8 weeks
Lipid profile: Total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) will be measured from fasting blood samples. Glycated hemoglobin (HbA1c, %) will be measured using high-performance liquid chromatography (HPLC). Fasting glucose (mg/dL or mmol/L) will be measured using an enzymatic glucose oxidase method. Fasting insulin (μIU/mL) will be measured using an electrochemiluminescence immunoassay. All blood samples will be collected after an overnight fast at baseline and after the 8-week IF intervention.
Changes in abdominal MRI findings (liver fat deposition) after 8-week IF intervention, assessed using magnetic resonance imaging
Time frame: 8 weeks
Abdominal fat distribution and liver fat content will be assessed using magnetic resonance imaging (MRI). Scans will be performed at baseline and after the 8-week IF intervention.
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 22 Sep 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.
Guang Wang principal investigator
Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, 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 5:2 intermittent fasting in people with Sensitivity to Thyroid Hormones and Metabolic Parameters, run by Beijing Chao Yang Hospital 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 6 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 22 Sep 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?
Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer (time frame: 8 weeks). The study lists 6 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 22 Sep 2025.