Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.

November 5, 2024 updated by: Institute of Liver and Biliary Sciences, India

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Delhi, India, 110070
        • Recruiting
        • Institute of Liver and Biliary Sciences
        • Contact:
        • Principal Investigator:
          • Babu Lal Meena, DM Hepatology
        • Sub-Investigator:
          • Shiv Kumar Sarin, DM, DSC(Hony)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criter

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADF
Experimental: Alternate day fasting, along with standard medical management.
Behavioral: Alternate day fasting
Alternate day fasting
No Intervention: Control arm
Standard medical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of NASH over a 24-week duration.
Time Frame: 24 weeks
Histologically confirmed NASH, biochemical resolution.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stage of fibrosis
Time Frame: Change from baseline to 24 weeks
Measured by fibroscan(LSM)
Change from baseline to 24 weeks
Weight
Time Frame: Change from baseline to 24 weeks
Change in weight at 1, 3, and 6 month of follow up.
Change from baseline to 24 weeks
Change in glycaemic status
Time Frame: Change from baseline to 24 weeks
Change in HbA1c level at baseline, 3 and 6 months.
Change from baseline to 24 weeks
Change in liver fat content
Time Frame: Change from baseline to 24 weeks
Measured by fibroscan(CAP)
Change from baseline to 24 weeks
Change in bone mineral density
Time Frame: Change from baseline to 24 weeks
As measured by dual-energy X ray absorptiometry (DEXA) scan
Change from baseline to 24 weeks
Change in faecal microbiota.
Time Frame: Change from baseline to 24 weeks
Stool analysis
Change from baseline to 24 weeks
Body mass index
Time Frame: 24 weeks
Change in body mass index at 1, 3, and 6 month of follow up.
24 weeks
Waist to hip ratio
Time Frame: 24 weeks
Change in Waist to hip ratio at 1, 3, and 6 month of follow up.
24 weeks
Change in the quality of life index
Time Frame: Change from baseline to 24 weeks

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.
Change from baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 22, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/8/2023-ACAD/E-12745/680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Alcoholic Steatohepatitis

Clinical Trials on Alternate day fasting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe