Non Alcoholic SteatohepatitisNCT06676813
Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.
A study testing Alternate day fasting in people with Non Alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- What is being tested?
- Alternate day fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to 30 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years. BMI 25-40kg/m3, and CAP more than 290
- Stable weight in the last 3 months prior to enrolling in the study(<5kg weight variation)
- Imaging showed steatotic liver disease, liver stiffness <14kPa measured by fibroscan
- Histologically proven NASH/MASH, fibrosis up to F3
- Subjects willing to participate in the study
Who cannot join
- Liver stiffness >14kPa measured by fibroscan or Fibrosis >F3
- Diabetes with HbA1c>8.5%
- Patients with another co-existing active liver disease e.g. hepatitis B or C, alcoholic liver disease
- Patients with cirrhosis, hepatocellular carcinoma(HCC), or other malignancy
- Chronic kidney disease, cardiovascular disorders, uncontrolled hypertension
- Chronic infections, chronic inflammatory diseases
- Patients on weight loss medications e.g semaglutide
- Pregnant or lactating women and those planning a pregnancy A patient who is not willing to participate in the study or failed to provide the consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
Delhi, 110070
Dr Babu Lal Meena, DM Hepatology, +91-9781100898, drbabupgi@gmail.com
Babu Lal Meena, DM Hepatology
About this study
Official title: Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis(NASH), A Randomized Controlled Trial. FAST Trial"
The aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH.
Read the detailed description
Emerging evidence suggests the role of alternate-day fasting (ADF) in patients with obesity and fatty liver. It helps to lose weight and improvement in liver fat content. ADF regimen protocol includes fast day(restricted calorie intake and time-specific feeding) and feast day(ad libitum feed over 24 hours). Lowering the weight and improvement of the fatty liver. NASH is a prevalent cause of liver disease. Literature is evident that ADF improves fatty liver and metabolic components, and NASH improves with weight loss. Still, data about the role of ADF in the management of NASH is lacking. Hence, this study focuses on the role of ADF in NASH.
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- Alternate day fasting
- Keywords
- Alternate day fasting., NASH, MASH, Steatotic liver disease, Cirrhosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate day fastingBehavioural
Alternate day fasting
| Study group | Role | What they receive |
|---|---|---|
| ADF | Experimental | Experimental: Alternate day fasting, along with standard medical management. Receives: Behavioral: Alternate day fasting |
| Control arm | No intervention | Standard medical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of NASH over a 24-week duration.
Histologically confirmed NASH, biochemical resolution.
Measured: 24 weeks
Secondary outcomes (9)
Change in the quality of life index
The investigators will assess the CLDQ-NASH score (Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis), which comprises 29 items rated on a scale from 1 to 7. Each item score reflects the patient's experience, with 1 indicating the worst and 7 indicating the best quality of life.
The average score across all 29 items provides an overall quality of life result:
- 1 to 3: Indicates a poor quality of life, with significant symptom burden and substantial impact on daily activities.
- 4 to 5: Suggests a moderate quality of life, where symptoms are present but manageable, with some limitations in daily activities.
- 6 to 7: Reflects a high quality of life, with minimal symptoms and few or no limitations on daily life.
Measured: Change from baseline to 24 weeks
Change in stage of fibrosis
Measured by fibroscan(LSM)
Measured: Change from baseline to 24 weeks
Weight
Change in weight at 1, 3, and 6 month of follow up.
Measured: Change from baseline to 24 weeks
Change in glycaemic status
Change in HbA1c level at baseline, 3 and 6 months.
Measured: Change from baseline to 24 weeks
Change in liver fat content
Measured by fibroscan(CAP)
Measured: Change from baseline to 24 weeks
Change in bone mineral density
As measured by dual-energy X ray absorptiometry (DEXA) scan
Measured: Change from baseline to 24 weeks
Change in faecal microbiota.
Stool analysis
Measured: Change from baseline to 24 weeks
Body mass index
Change in body mass index at 1, 3, and 6 month of follow up.
Measured: 24 weeks
Waist to hip ratio
Change in Waist to hip ratio at 1, 3, and 6 month of follow up.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676813
- Sponsor's protocol ID
- 12/8/2023-ACAD/E-12745/680
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators currently do not plan to share individual participant data (IPD) from this study. The decision is based on considerations of patient privacy, confidentiality concerns, and the lack of a data-sharing infrastructure. While the aggregated study results will be published and made publicly available, sharing individual-level data could pose risks related to identifying participants. Therefore, IPD will not be shared beyond what is required for regulatory purposes.
Publications
Teng ML, Ng CH, Huang DQ, Chan KE, Tan DJ, Lim WH, Yang JD, Tan E, Muthiah MD. Global incidence and prevalence of nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S32-S42. doi: 10.3350/cmh.2022.0365. Epub 2022 Dec 14.
PubMed 36517002Carr RM, Oranu A, Khungar V. Nonalcoholic Fatty Liver Disease: Pathophysiology and Management. Gastroenterol Clin North Am. 2016 Dec;45(4):639-652. doi: 10.1016/j.gtc.2016.07.003. Epub 2016 Oct 13.
PubMed 27837778Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.
PubMed 22488764Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24.
PubMed 37363821Loomba R, Wong R, Fraysse J, Shreay S, Li S, Harrison S, Gordon SC. Nonalcoholic fatty liver disease progression rates to cirrhosis and progression of cirrhosis to decompensation and mortality: a real world analysis of Medicare data. Aliment Pharmacol Ther. 2020 Jun;51(11):1149-1159. doi: 10.1111/apt.15679. Epub 2020 May 5.
PubMed 32372515Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available.
PubMed 36727674Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
PubMed 20427778Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.
PubMed 19827166van den Hoek AM, de Jong JCBC, Worms N, van Nieuwkoop A, Voskuilen M, Menke AL, Lek S, Caspers MPM, Verschuren L, Kleemann R. Diet and exercise reduce pre-existing NASH and fibrosis and have additional beneficial effects on the vasculature, adipose tissue and skeletal muscle via organ-crosstalk. Metabolism. 2021 Nov;124:154873. doi: 10.1016/j.metabol.2021.154873. Epub 2021 Sep 1.
PubMed 34478753Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25.
PubMed 22213436Yang W, Cao M, Mao X, Wei X, Li X, Chen G, Zhang J, Wang Z, Shi J, Huang H, Yao X, Liu C. Alternate-day fasting protects the livers of mice against high-fat diet-induced inflammation associated with the suppression of Toll-like receptor 4/nuclear factor kappaB signaling. Nutr Res. 2016 Jun;36(6):586-93. doi: 10.1016/j.nutres.2016.02.001. Epub 2016 Feb 16.
PubMed 27188904Wei X, Lin B, Huang Y, Yang S, Huang C, Shi L, Liu D, Zhang P, Lin J, Xu B, Guo D, Li C, He H, Liu S, Xue Y, Xu Y, Zhang H. Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513.
PubMed 36930148Cai H, Qin YL, Shi ZY, Chen JH, Zeng MJ, Zhou W, Chen RQ, Chen ZY. Effects of alternate-day fasting on body weight and dyslipidaemia in patients with non-alcoholic fatty liver disease: a randomised controlled trial. BMC Gastroenterol. 2019 Dec 18;19(1):219. doi: 10.1186/s12876-019-1132-8.
PubMed 31852444Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17.
PubMed 22608008
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis(NASH), A Randomized Controlled Trial. FAST Trial"
- ClinicalTrials.gov ID
- NCT06676813
- Acronym / sponsor ID
- 12/8/2023-ACAD/E-12745/680
- Conditions
- Non Alcoholic Steatohepatitis
- Keywords
- Alternate day fasting., NASH, MASH, Steatotic liver disease, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Nov 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 aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH.
Detailed description
Emerging evidence suggests the role of alternate-day fasting (ADF) in patients with obesity and fatty liver. It helps to lose weight and improvement in liver fat content. ADF regimen protocol includes fast day(restricted calorie intake and time-specific feeding) and feast day(ad libitum feed over 24 hours). Lowering the weight and improvement of the fatty liver. NASH is a prevalent cause of liver disease. Literature is evident that ADF improves fatty liver and metabolic components, and NASH improves with weight loss. Still, data about the role of ADF in the management of NASH is lacking. Hence, this study focuses on the role of ADF in NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| ADF | Experimental | Behavioral: Alternate day fastingExperimental: Alternate day fasting, along with standard medical management. |
| Control arm | No intervention | –Standard medical management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years. BMI 25-40kg/m3, and CAP more than 290
- Stable weight in the last 3 months prior to enrolling in the study(<5kg weight variation)
- Imaging showed steatotic liver disease, liver stiffness <14kPa measured by fibroscan
- Histologically proven NASH/MASH, fibrosis up to F3
- Subjects willing to participate in the study
Key exclusion criteria (8 listed)
- Liver stiffness >14kPa measured by fibroscan or Fibrosis >F3
- Diabetes with HbA1c>8.5%
- Patients with another co-existing active liver disease e.g. hepatitis B or C, alcoholic liver disease
- Patients with cirrhosis, hepatocellular carcinoma(HCC), or other malignancy
- Chronic kidney disease, cardiovascular disorders, uncontrolled hypertension
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 |
|---|---|---|
| Alternate day fastingAlternate day fasting | Behavioural | ADF |
Primary outcome
Change of NASH over a 24-week duration.
Time frame: 24 weeks
Histologically confirmed NASH, biochemical resolution.
9 secondary outcomes
Change in the quality of life index
Time frame: Change from baseline to 24 weeks
Change in stage of fibrosis
Time frame: Change from baseline to 24 weeks
Weight
Time frame: Change from baseline to 24 weeks
Change in glycaemic status
Time frame: Change from baseline to 24 weeks
Change in liver fat content
Time frame: Change from baseline to 24 weeks
Change in bone mineral density
Time frame: Change from baseline to 24 weeks
Change in faecal microbiota.
Time frame: Change from baseline to 24 weeks
Body mass index
Time frame: 24 weeks
Waist to hip ratio
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 36517002Teng ML, Ng CH, Huang DQ, Chan KE, Tan DJ, Lim WH, Yang JD, Tan E, Muthiah MD. Global incidence and prevalence of nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S32-S42. doi: 10.3350/cmh.2022.0365. Epub 2022 Dec 14.
- Background: PubMed 27837778Carr RM, Oranu A, Khungar V. Nonalcoholic Fatty Liver Disease: Pathophysiology and Management. Gastroenterol Clin North Am. 2016 Dec;45(4):639-652. doi: 10.1016/j.gtc.2016.07.003. Epub 2016 Oct 13.
- Background: PubMed 22488764Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.
- Background: PubMed 37363821Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24.
- Background: PubMed 32372515Loomba R, Wong R, Fraysse J, Shreay S, Li S, Harrison S, Gordon SC. Nonalcoholic fatty liver disease progression rates to cirrhosis and progression of cirrhosis to decompensation and mortality: a real world analysis of Medicare data. Aliment Pharmacol Ther. 2020 Jun;51(11):1149-1159. doi: 10.1111/apt.15679. Epub 2020 May 5.
- Background: PubMed 36727674Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available.
- Background: PubMed 20427778Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.
- Background: PubMed 19827166Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.
- Background: PubMed 34478753van den Hoek AM, de Jong JCBC, Worms N, van Nieuwkoop A, Voskuilen M, Menke AL, Lek S, Caspers MPM, Verschuren L, Kleemann R. Diet and exercise reduce pre-existing NASH and fibrosis and have additional beneficial effects on the vasculature, adipose tissue and skeletal muscle via organ-crosstalk. Metabolism. 2021 Nov;124:154873. doi: 10.1016/j.metabol.2021.154873. Epub 2021 Sep 1.
- Background: PubMed 22213436Sullivan S, Kirk EP, Mittendorfer B, Patterson BW, Klein S. Randomized trial of exercise effect on intrahepatic triglyceride content and lipid kinetics in nonalcoholic fatty liver disease. Hepatology. 2012 Jun;55(6):1738-45. doi: 10.1002/hep.25548. Epub 2012 Apr 25.
- Background: PubMed 27188904Yang W, Cao M, Mao X, Wei X, Li X, Chen G, Zhang J, Wang Z, Shi J, Huang H, Yao X, Liu C. Alternate-day fasting protects the livers of mice against high-fat diet-induced inflammation associated with the suppression of Toll-like receptor 4/nuclear factor kappaB signaling. Nutr Res. 2016 Jun;36(6):586-93. doi: 10.1016/j.nutres.2016.02.001. Epub 2016 Feb 16.
- Background: PubMed 36930148Wei X, Lin B, Huang Y, Yang S, Huang C, Shi L, Liu D, Zhang P, Lin J, Xu B, Guo D, Li C, He H, Liu S, Xue Y, Xu Y, Zhang H. Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513.
- Individual participant dataSharing planned: No. Investigators currently do not plan to share individual participant data (IPD) from this study. The decision is based on considerations of patient privacy, confidentiality concerns, and the lack of a data-sharing infrastructure. While the aggregated study results will be published and made publicly available, sharing individual-level data could pose risks related to identifying participants. Therefore, IPD will not be shared beyond what is required for regulatory purposes.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate day fasting in people with Non Alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2024. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Babu Lal Meena, DM Hepatology (+91-9781100898, drbabupgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of NASH over a 24-week duration. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676813, which also lists 14 linked publications.
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 Nov 2024.