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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alternate day fasting

    Behavioral

    Alternate day fasting

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: ADFExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change of NASH over a 24-week duration.

Histologically confirmed NASH, biochemical resolution.

Time frame
24 weeks

Secondary outcomes

1

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.

Time frame
Change from baseline to 24 weeks
2

Change in stage of fibrosis

Measured by fibroscan(LSM)

Time frame
Change from baseline to 24 weeks
3

Weight

Change in weight at 1, 3, and 6 month of follow up.

Time frame
Change from baseline to 24 weeks
4

Change in glycaemic status

Change in HbA1c level at baseline, 3 and 6 months.

Time frame
Change from baseline to 24 weeks

Other outcomes

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