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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04004403
Other study ID # 2019-0300
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date May 1, 2024

Study information

Verified date November 2023
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility INCLUSION CRITERIA: - Age between 18 to 65 years old - BMI between 30.0 and 59.9 kg/m2 - NAFLD (hepatic steatosis = 5% confirmed by MRI-PDFF) - Sedentary (<20 min, 2x/week of light activity at 3-4 metabolic equivalents (METs) for 3 mo prior to study) EXCLUSION CRITERIA: - Have chronic liver disease other than NAFLD (hepatitis B or C, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, a1-antitrypsin deficiency) - Consume excessive amounts of alcohol women: 70 g of ethanol (5 alcoholic drinks per week) and men 140 g of ethanol (10 drinks per week) in the past 6 months) - Have a history of known cardiovascular, pulmonary or renal disease - Diagnosed T1DM or T2DM - Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg) - Are claustrophobic or have implanted metallic/electrical devices (e.g. cardiac pacemaker, neuro-stimulator) - Are taking drugs that induce steatosis (e.g. corticosteroids, estrogens, methotrexate, Ca channel blockers) - Are taking drugs that benefit NAFLD (e.g. betaine, pioglitazone, rosiglitazone, metformin, or gemifibrozil) - Are taking drugs that influence study outcomes (weight loss medications) - Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days) - Are pregnant, or trying to become pregnant - Are smokers

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Alternate day fasting
The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
Exercise
The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.

Locations

Country Name City State
United States University of Illinois Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in hepatic steatosis Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF) Change from week 1 to week 12
Secondary Change in body weight Measured by digital scale Change from week 1 to week 12
Secondary Change in lean mass Measured by dual-energy x-ray absorptiometry (DXA) Change from week 1 to week 12
Secondary Change in fat mass Measured by dual-energy x-ray absorptiometry (DXA) Change from week 1 to week 12
Secondary Change in visceral fat mass Measured by dual-energy x-ray absorptiometry (DXA) Change from week 1 to week 12
Secondary Change in Alanine Aminotransferase (ALT) Measured by a commercial lab (Medstar, Inc) Change from week 1 to week 12
Secondary Change in Aspartate Aminotransferase (AST) Measured by a commercial lab (Medstar, Inc) Change from week 1 to week 12
Secondary Change in fasting glucose Measured by a commercial lab (Medstar, Inc) Change from week 1 to week 12
Secondary Change in fasting insulin Measured by a commercial lab (Medstar, Inc) Change from week 1 to week 12
Secondary Change in insulin sensitivity Measured by Quantitative insulin sensitivity check index (QUICKI) Change from week 1 to week 12
Secondary Change in insulin resistance Measured by Homeostatic model assessment (HOMA) Change from week 1 to week 12
Secondary Change in plasma lipid levels Measured by a commercial lab (Medstar, Inc) Change from week 1 to week 12
Secondary Change in HbA1c Measured by a commercial lab (Medstar, Inc) Change from week 1 to week 12
Secondary Change in blood pressure Measured by a blood pressure cuff Change from week 1 to week 12
Secondary Change in heart rate Measured by a blood pressure cuff Change from week 1 to week 12
Secondary Dietary intake Measured by a 7-day food record Change from week 1 to week 12
Secondary Physical activity Measured by an activity monitor (Fitbit Alta) Change from week 1 to week 12
Secondary Hepatokine - Fetuin-A (ng/ml) Measured by ELISA Change from week 1 to week 12
Secondary Hepatokine - FGF-21 (ng/ml) Measured by ELISA Change from week 1 to week 12
Secondary Hepatokine - Selenoprotein P (ng/ml) Measured by ELISA Change from week 1 to week 12
Secondary Sleep quality and duration 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. Change from week 1 to week 12
Secondary Insonmia severity 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 from week 1 to week 12
Secondary Risk of obstructive sleep apnea Measured using the 10-item self-report Berlin Questionnaire which estimates % occurrences of sleep apnea Change from week 1 to week 12
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