Alternate Day Fasting, Exercise, and NAFLD
- Conditions
- Non-Alcoholic Fatty Liver DiseaseObesity
- Interventions
- Other: ExerciseOther: Alternate day fasting
- Registration Number
- NCT04004403
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes. Innovative lifestyle strategies to treat NAFLD are critically needed. The proposed research will demonstrate that alternate day fasting (ADF) combined with exercise is an effective non-pharmacological therapy to treat NAFLD.
- Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver (not resulting from excessive alcohol consumption). Approximately 65% of obese individuals have NAFLD, and this condition is strongly related to the development of insulin resistance and type 2 diabetes. While certain pharmacological agents have been shown to reduce liver fat (i.e. thiazolidinediones), there is mounting concern regarding the safety and weight-gaining effects of these compounds. In light of this, recent research has focused on non-pharmacological lifestyle therapies to reduce hepatic steatosis, such as daily calorie restriction combined with aerobic exercise. Evidence from clinical trials suggest that this combination is an effective lifestyle therapy improve liver fat content and hepatic insulin sensitivity.
More recently, it's been shown that intermittent fasting may produce even greater improvements in hepatic steatosis and hepatic insulin sensitivity, when compared to conventional calorie restriction. For instance, intrahepatic lipid accumulation was lower and insulin sensitivity was higher in mice fasted every other day, when compared to mice who were energy restricted every day. Moreover, data from human trials show that adults with obesity experience greater decreases in insulin and insulin resistance with intermittent fasting versus daily restriction. These findings suggest that intermittent fasting may be a more effective diet therapy to reduce hepatic steatosis and improve insulin sensitivity, when compared to daily calorie restriction. Although these findings are very promising, these data still require confirmation by a randomized controlled clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Exercise These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. Combination alternate day fasting plus exercise Exercise These 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. Alternate day fasting Alternate day fasting 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 exercise Alternate day fasting These 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.
- Primary Outcome Measures
Name Time Method Change in hepatic steatosis Change from week 1 to week 12 Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)
- Secondary Outcome Measures
Name Time Method Change in body weight Change from week 1 to week 12 Measured by digital scale
Change in Aspartate Aminotransferase (AST) Change from week 1 to week 12 Measured by a commercial lab (Medstar, Inc)
Hepatokine - FGF-21 (ng/ml) Change from week 1 to week 12 Measured by ELISA
Risk of obstructive sleep apnea Change from week 1 to week 12 Measured using the 10-item self-report Berlin Questionnaire which estimates % occurrences of sleep apnea
Change in insulin sensitivity Change from week 1 to week 12 Measured by Quantitative insulin sensitivity check index (QUICKI)
Change in plasma lipid levels Change from week 1 to week 12 Measured by a commercial lab (Medstar, Inc)
Physical activity Change from week 1 to week 12 Measured by an activity monitor (Fitbit Alta)
Change in visceral fat mass Change from week 1 to week 12 Measured by dual-energy x-ray absorptiometry (DXA)
Change in fasting insulin Change from week 1 to week 12 Measured by a commercial lab (Medstar, Inc)
Change in insulin resistance Change from week 1 to week 12 Measured by Homeostatic model assessment (HOMA)
Change in HbA1c Change from week 1 to week 12 Measured by a commercial lab (Medstar, Inc)
Change in blood pressure Change from week 1 to week 12 Measured by a blood pressure cuff
Dietary intake Change from week 1 to week 12 Measured by a 7-day food record
Hepatokine - Fetuin-A (ng/ml) Change from week 1 to week 12 Measured by ELISA
Hepatokine - Selenoprotein P (ng/ml) Change from week 1 to week 12 Measured by ELISA
Change in fat mass Change from week 1 to week 12 Measured by dual-energy x-ray absorptiometry (DXA)
Change in Alanine Aminotransferase (ALT) Change from week 1 to week 12 Measured by a commercial lab (Medstar, Inc)
Change in lean mass Change from week 1 to week 12 Measured by dual-energy x-ray absorptiometry (DXA)
Change in fasting glucose Change from week 1 to week 12 Measured by a commercial lab (Medstar, Inc)
Insonmia severity Change from week 1 to week 12 Measured by the Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire that rates each item by a 5-point Likert scale, resulting in a total score of 0-28. Scores are stratified into the following categories: no clinically significant insomnia (0-7); subthreshold insomnia (8-14); moderate severity insomnia (15-21); and severe insomnia (22-28).
Change in heart rate Change from week 1 to week 12 Measured by a blood pressure cuff
Sleep quality and duration Change from week 1 to week 12 Measured by Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item self-report questionnaire that measures sleep quality in the past month, resulting in a total score of 0-21. Scores above 5 indicate poor sleep quality.
Trial Locations
- Locations (1)
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States