RecruitingACTRN12613000935730

Non-alcoholic fatty liver disease Intermittent Fasting Time Intervention

A 24 week randomised controlled cross-over pilot study assessing the effects of an 8 hr time restricted feeding regime or standard dietary advice on hepatic steatosis, visceral fat and biochemical parameters of metabolic syndrome in adults with non-alcoholic fatty liver disease.

Sponsor

Monash University

Enrollment

58 participants

Start Date

Feb 14, 2013

Study Type

Interventional

Conditions

visceral adiposity

Summary

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide affecting 15 to 45% of the adult population. NAFLD is a spectrum from simple fat (NAFLD) to fat and inflammation (non-alcoholic steatohepatitis (NASH). Ten to 25% of NASH cases progress onto advanced hepatic fibrosis and cirrhosis with its complications of end stage liver disease and liver cancer. NAFLD is part of a group of medical conditions called the metabolic syndrome. These include type-2 diabetes, high blood pressure, high cholesterol and abdominal obesity. The presence of NAFLD is also associated with wide ranging health problems including obstructive sleep apnoea, polycystic ovary syndrome, colon polyps, hypothyroidism and vitamin D deficiency. This project aims to assess whether NAFLD can be improved by undertaking a controlled period of fasting. Previous research has shown that controlled periods of fasting can improve diabetes and cholesterol in these patients but no one has ever looked at NAFLD. This project will involve approximately 60 people in two groups all at Monash Health. Each group will contain 30 people. One group will follow a diet plan that involves a period of controlled fasting during each day from 8pm at night until 12pm the following day, while the other will follow the current Gastoenterological Society of Australia standard treatment guidelines for NAFLD. At 12 weeks, participants will be invited to take part in the other treatment group for a further 12 weeks (a total of 24 weeks). Each study participant will have a series of assessments done at baseline and at various points throughout the study. This will include anthropometric measurements, abdominal fat content via single slice CT scan, Fibroscan for liver steatosis, body composition (fat and lean muscle mass) and blood tests. After 12 weeks we hope to see a 25% improvement in the amount of abdominal and liver fat from baseline. Other intended improvements may be in blood markers of inflammation and metabolism.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether time-restricted eating (a form of intermittent fasting) can reduce fat in the liver and belly in people with non-alcoholic fatty liver disease (NAFLD). NAFLD is when too much fat builds up in the liver even without drinking alcohol. In serious cases it can lead to liver damage, scarring, and even liver cancer. In this 12-week program, one group of participants fasts from 8pm at night until noon the following day. Researchers will measure liver fat, belly fat, and blood markers to see if this eating pattern helps. You may be eligible if: - You are between 18 and 75 years old - You have been told by a doctor that you have a fatty liver (shown on ultrasound) - You are male or female You may NOT be eligible if: - You drink more than 30g of alcohol per day (men) or 20g per day (women), or have a history of heavy drinking in the past 10 years - You have hepatitis B or C, or another liver disease - You have type 2 diabetes and are on insulin - You are pregnant or breastfeeding - You have liver cirrhosis (scarring) - You are taking certain medications that affect the liver (corticosteroids, tamoxifen, amiodarone, methotrexate, vitamin E, and others) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Subjects allocated to the intermittent fasting (IF) arm will be instructed to withhold all food and energy containing drinks for 16 hours from 8pm until 12 noon the following day. During this time, water, black tea and black coffee are permitted. Between the hours of noon and 8pm, subjects are able to consume food as desired. Those in the IF intervention proceed for 12 weeks upon which time participants will "cross over" to the standard dietary advice group for an additional 12 weeks (total of 24 weeks). There is no wash-out period per se. This latter 12 weeks to to determine how long the effects of IF last. The "control" or standard dietary intervention group will proceed for 12 weeks upon which time they "cross over" to have IF for 12 weeks (total 24 weeks). There is no wash out period. To determine adherence to lifestyle management strategies (IF or control) each subject will complete a 3 day total food diary. The first will be complete at baseline and then every 2 weeks for the total 24 weeks. Participants will also be contacted every 2 weeks by an investigator to give encouragement and answer any questions that may arise. Participants will be given a mobile phone number that they can contact during working hours if they need assistance or have questions between the 2 weekly phone calls.

Locations(1)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12613000935730