Alternate day fasting for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Illinois Chicago, Chicago, IL
Obesity+6 More
Alternate day fasting - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether alternate day fasting combined with exercise is an effective non-pharmacological therapy to help obese prediabetic individuals with non-alcoholic fatty liver disease (NAFLD) reduce fatty liver and prevent progression of prediabetes

See full description

Eligible Conditions

  • Obesity
  • Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
  • Pre-diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Obesity

Study Objectives

This trial is evaluating whether Alternate day fasting will improve 1 primary outcome and 16 secondary outcomes in patients with Obesity. Measurement will happen over the course of Change from week 1 to week 12.

Week 12
Change in Alanine Aminotransferase (ALT)
Change in Aspartate Aminotransferase (AST)
Change in HbA1c
Change in blood pressure
Change in body weight
Change in fasting glucose
Change in fasting insulin
Change in fat mass
Change in heart rate
Change in hepatic steatosis
Change in insulin resistance
Change in insulin sensitivity
Change in lean mass
Change in plasma lipid levels
Change in visceral fat mass
Dietary intake
Physical activity

Trial Safety

Safety Progress

1 of 3

Other trials for Obesity

Trial Design

4 Treatment Groups

Control
1 of 4
Alternate day fasting
1 of 4
Combination alternate day fasting plus exercise
1 of 4
Exercise
1 of 4
Active Control
Experimental Treatment

This trial requires 80 total participants across 4 different treatment groups

This trial involves 4 different treatments. Alternate Day Fasting is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Alternate day fasting
Other
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Combination alternate day fasting plus exerciseThese participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
Exercise
Other
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
ControlControls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from week 1 to week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from week 1 to week 12 for reporting.

Who is running the study

Principal Investigator
K. V.
Prof. Krista Varady, Professor of Nutrition
University of Illinois at Chicago

Closest Location

University of Illinois Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age between 18 to 65 years old
BMI between 30.0 and 49.9 kg/m2
NAFLD (hepatic steatosis ≥ 5%)
Prediabetic
Sedentary (<20 min, 2x/week of light activity for 3 mo prior to study)

Patient Q&A Section

What are common treatments for nonalcoholic steatohepatitis?

"This is the first study to identify that lifestyle modifications and exercise training are the treatment choice in patients with NASH. The present study also suggested that other therapy strategies should be established to further improve its quality of life." - Anonymous Online Contributor

Unverified Answer

Can nonalcoholic steatohepatitis be cured?

"Chronic liver disease can be cured. However, the best long-term outcomes depend largely on management of the underlying metabolic syndrome and lifestyle factors. Lifestyle changes are important in the treatment of nonalcoholic steatohepatitis." - Anonymous Online Contributor

Unverified Answer

What causes nonalcoholic steatohepatitis?

"The association between obesity and nonalcoholic steatohepatitis suggests common genetic or environmental factors. The association of nonalcoholic steatohepatitis with insulin resistance is consistent with the hypothesis that hepatic steatosis may lead to insulin resistance through various mediations. Prospective studies of the development of insulin resistance and fat accumulation throughout the liver throughout the life course, with follow-up of those with steatohepatitis, are needed to determine the role of steatosis in developing insulin resistance and associated metabolic disorders." - Anonymous Online Contributor

Unverified Answer

How many people get nonalcoholic steatohepatitis a year in the United States?

"At least 2.3 million people have NASH in the United States. The prevalence of NASH in this study is slightly higher than in most other studies with most studies in the United States reporting prevalences of approximately 2.0% to 2.5% of the general population." - Anonymous Online Contributor

Unverified Answer

What are the signs of nonalcoholic steatohepatitis?

"In patients with NASH, liver disease can be detected by an elevated alanine aminotransferase and bilirubin levels. Ultrasonographic features of nonalcoholic steatohepatitis can be identified, but cholestasis is not evident." - Anonymous Online Contributor

Unverified Answer

What is nonalcoholic steatohepatitis?

"Liver biopsies performed for all clinical indications (including ALD, chronic viral hepatitis, autoimmune diseases, HBV, HCV, metastatic and hepatocellular carcinoma) are of great value for identifying nonalcoholic fatty liver disease. This is a condition with diverse histological subtypes that, if left untreated leads to a significant increase in mortality and morbidity rates, since nonalcoholic steatohepatitis is associated with increased risk of hepatic fibrosis and cirrhosis, cardiovascular disease, and complications in the skeletal muscle. Thus, nonalcoholic steatohepatitis requires special attention since its histological sub-type has been demonstrated to cause significant increase mortality in certain sub-populations." - Anonymous Online Contributor

Unverified Answer

How does alternate day fasting work?

"Alternating-day fasting can have a beneficial effect on glycaemic control and lipid metabolism but does not seem to change hepatic insulin sensitivity. This trial is registered at clinicaltrials.gov: NCT00267725." - Anonymous Online Contributor

Unverified Answer

Is alternate day fasting safe for people?

"The new method of AF is not associated with serious adverse outcomes in this heterogeneous study, including patients having a history of obesity. Clinicians might consider switching to this less restrictive, healthier method of losing weight." - Anonymous Online Contributor

Unverified Answer

Has alternate day fasting proven to be more effective than a placebo?

"ADF is well tolerated, does not adversely affect hepatic biochemistry or liver function, and is capable of reversing abnormal hepatic profiles in patients with nonalcoholic fatty liver disease with or without steatohepatitis, particularly if the individual treatment is long term." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for nonalcoholic steatohepatitis?

"There is a general consensus within the NAFLD community that NASH should fall within the specialty of internists (generalists are not well suited for NASH treatment and it's associated complications). However, this consensus is not strong enough to recommend that the majority of patients with NASH participate in a clinical trial vs. a traditional treatment approach (e.g. nonclective drug therapies in a primary care setting)." - Anonymous Online Contributor

Unverified Answer

Does nonalcoholic steatohepatitis run in families?

"Obesity and metabolic syndrome increased the risk of developing NAFLD in first degree relatives. Further studies are required to understand the interaction between metabolic syndrome and NAFLD." - Anonymous Online Contributor

Unverified Answer

Does alternate day fasting improve quality of life for those with nonalcoholic steatohepatitis?

"ADF might be a therapeutic option with the potential to improve patient quality of life through alleviation of symptoms and discomfort associated with hepatic steatosis, and should prompt further research on its potential benefits." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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