NAFLDNCT06101433
The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A
A study testing Soy isoflavone in people with NAFLD, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
Trial summary
In this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Soy isoflavone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIran
- Study dates
- 6 Sep 2022to 11 May 2023
- 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
- 18 years or older
- without any history of allergy to soy or excessive consumption of soy products
- without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent;
- hepatic steatosis grade 2 and higher with fibroscan confirmation (CAP > 260 dB/m);
- without history of excessive alcohol drink (≥10 g/day);
- without history of drug consumption with approved positive effects on NAFLD treatment (i.e. metformin, vitamin E, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate) in last three months;
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- without the history of bariatric surgery or following weight loss diets within 6 months;
- without history of smoking;
- not being a pregnant or lactating woman
Who cannot join
- consuming less than 90% of intended supplements.
- unwillingness for study collaboration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of Fibroblast Growth Factor-21 and Fetuin A
In this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of the present study was to investigate the effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth factor-21 (FGF-21) and fetuin A in patients with NAFLD. Fifty patients with NAFLD were randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. Dietary intakes, anthropometric parameters, the serum levels of liver function tests including alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT), FGF-21, fetuin A and hepatic histological features by Fibroscan assessed at study initiation and after week 12.
- Conditions
- NAFLD
- Being tested
- Soy isoflavone, Placebo
- Keywords
- Non-alcoholic fatty liver disease, Isoflavones, Soy foods, FGF21, Liver steatosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavoneDietary supplement
Also called Soyagol
the subjects in the soy isoflavone group were told to take 2 drugs per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks.
PlaceboOther
the subjects in the placebo group were told to take 2 placebo tablets per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The placebo group | Placebo comparator | Subjects in the placebo group, were advised to take two placebo tablets per day for 12 weeks along with life style modification such as physical activity of 30 minutes for 3 days per week with medium intensity and food intake consults provided by clinical guidelines of NIH and the North American Association for the Study of Obesity. The placebo tablets contained starch and they were similar to the soy isoflavone tablets in smell, taste, and appearance. The placebo tablets were made by Gol Daru Pharmaceutical Company, Isfahan, Iran. Receives: Other: Placebo |
| The soy isoflavone group | Active comparator | In the soy isoflavone group, patients took 100 mg soy isoflavone in the form of two tablets per day for 12 weeks along with lifestyle modification. Each soy isoflavone 50 mg tablet contained 1.49 mg of genistein, 31.86 mg of genistin, 1.75 mg of daidzein, 13.21 mg of daidzin, 0.55 mg of glycitein and 1.14 mg of glycitin. The soy isoflavone tablets were made by Gol Daru Pharmaceutical Company, Isfahan, Iran. Receives: Dietary Supplement: Soy isoflavone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic histological features by Fibroscan
The subject's hepatic histological features using Fibroscan (Echosense, France) assessed at study initiation and at week 12.
Measured: 12 weeks
The Level of serum liver enzymes
The serum levels of alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT) measured through enzymatic methods by Delta Darman Part test kits (Delta darman part, Tehran, Iran) at study initiation and at the end of the trial
Measured: 12 weeks
Secondary outcomes (2)
fibroblast growth factor-21 (FGF-21)
The serum level of FGF-21 measured via ELISA commercial kits (ZellBio GmbH Veltlinerweg 29, 89075, Ulm, Germany) at study initiation and at week 12.
Measured: 12 weeks
Fetuin A
The serum level of fetuin A measured via ELISA commercial kits (ZellBio GmbH Veltlinerweg 29, 89075, Ulm, Germany) at study initiation and at week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start6 Sep 2022
- Primary completion12 Mar 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly classified into placebo or soy isoflavone groups using block randomization stratified by menopause status and gender for 12 weeks
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahvaz Jundishapur University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asal Neshatbini Tehrani, Ahvaz Jundishapur University of Medical Sciences
- Investigators
- Asal Neshatbini Tehrani, PhD, Principal investigator, Ahvaz Jundishapur University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101433
- Sponsor's protocol ID
- ATehrani
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data that support the findings of this study are available from the corresponding author, upon reasonable request by contacting the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of Fibroblast Growth Factor-21 and Fetuin A
- ClinicalTrials.gov ID
- NCT06101433
- Acronym / sponsor ID
- ATehrani
- Conditions
- NAFLD
- Keywords
- Non-alcoholic fatty liver disease, Isoflavones, Soy foods, FGF21, Liver steatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ahvaz Jundishapur University of Medical SciencesUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 26 Oct 2023 (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.
In this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of the present study was to investigate the effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth factor-21 (FGF-21) and fetuin A in patients with NAFLD. Fifty patients with NAFLD were randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. Dietary intakes, anthropometric parameters, the serum levels of liver function tests including alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT), FGF-21, fetuin A and hepatic histological features by Fibroscan assessed at study initiation and after week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients were randomly classified into placebo or soy isoflavone groups using block randomization stratified by menopause status and gender for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| The placebo group | Placebo comparator | Other: PlaceboSubjects in the placebo group, were advised to take two placebo tablets per day for 12 weeks along with life style modification such as physical activity of 30 minutes for 3 days per week with medium intensity and food intake consults provided by clinical guidelines of NIH and the North American Association for the Study of Obesity. The placebo tablets contained starch and they were similar to the soy isoflavone tablets in smell, taste, and appearance. The placebo tablets were made by Gol Daru Pharmaceutical Company, Isfahan, Iran. |
| The soy isoflavone group | Active comparator | Dietary Supplement: Soy isoflavoneIn the soy isoflavone group, patients took 100 mg soy isoflavone in the form of two tablets per day for 12 weeks along with lifestyle modification. Each soy isoflavone 50 mg tablet contained 1.49 mg of genistein, 31.86 mg of genistin, 1.75 mg of daidzein, 13.21 mg of daidzin, 0.55 mg of glycitein and 1.14 mg of glycitin. The soy isoflavone tablets were made by Gol Daru Pharmaceutical Company, Isfahan, Iran. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- without any history of allergy to soy or excessive consumption of soy products
- without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent;
- hepatic steatosis grade 2 and higher with fibroscan confirmation (CAP > 260 dB/m);
- without history of excessive alcohol drink (≥10 g/day);
Key exclusion criteria (2 listed)
- consuming less than 90% of intended supplements.
- unwillingness for study collaboration
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 |
|---|---|---|
| Soy isoflavoneAlso: Soyagolthe subjects in the soy isoflavone group were told to take 2 drugs per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks. | Dietary supplement | The soy isoflavone group |
| Placebothe subjects in the placebo group were told to take 2 placebo tablets per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks. | Other | The placebo group |
Primary outcome
Hepatic histological features by Fibroscan
Time frame: 12 weeks
The subject's hepatic histological features using Fibroscan (Echosense, France) assessed at study initiation and at week 12.
The Level of serum liver enzymes
Time frame: 12 weeks
The serum levels of alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT) measured through enzymatic methods by Delta Darman Part test kits (Delta darman part, Tehran, Iran) at study initiation and at the end of the trial
2 secondary outcomes
fibroblast growth factor-21 (FGF-21)
Time frame: 12 weeks
Fetuin A
Time frame: 12 weeks
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 26 Oct 2023.
- Individual participant dataSharing planned: Yes. Raw data that support the findings of this study are available from the corresponding author, upon reasonable request by contacting the principal investigator
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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.
Asal Neshatbini Tehrani, PhD principal investigator
Ahvaz Jundishapur University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy isoflavone in people with NAFLD, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
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 9 inclusion and 2 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 26 Oct 2023. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
Hepatic histological features by Fibroscan (time frame: 12 weeks). 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 26 Oct 2023.