Alternate Day Fasting Combined With Exercise for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Hepatic Steatosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Have chronic liver disease other than NAFLD (hepatitis B or C, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α1-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
研究组 & 干预措施
Alternate day fasting
These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days".
干预措施: Alternate day fasting (Other)
Exercise
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax.
干预措施: Exercise (Other)
Combination alternate day fasting plus 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.
干预措施: Alternate day fasting (Other)
Combination alternate day fasting plus 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.
干预措施: Exercise (Other)
Control
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits.
结局指标
主要结局
Change in Hepatic Steatosis
时间窗: Change from week 1 to week 12
Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)
次要结局
- Change in Alanine Aminotransferase (ALT)(Change from week 1 to week 12)
- Change in Aspartate Aminotransferase (AST)(Change from week 1 to week 12)
- Change in HbA1c(Change from week 1 to week 12)
- Change in Body Weight(Change from week 1 to week 12)
- Change in Alanine Aminotransferase (ALT)(Change from week 1 to week 12)
- Change in Aspartate Aminotransferase (AST)(Change from week 1 to week 12)
- Change in Fasting Glucose(Change from week 1 to week 12)
- Change in Fasting Insulin(Change from week 1 to week 12)
- Change in Insulin Resistance(Change from week 1 to week 12)
- Change in HbA1c(Change from week 1 to week 12)
研究者
Krista Varady
Professor of Nutrition
University of Illinois at Chicago