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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK119783 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternate day fasting | Experimental | These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". |
|
| Exercise | Experimental | 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 | Experimental | 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. |
|
| Control | No Intervention | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate day fasting | Other | The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hepatic Steatosis | Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF) | Change from week 1 to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Measured by digital scale | Change from week 1 to week 12 |
| Change in Alanine Aminotransferase (ALT) | Measured by a commercial lab (Medstar, Inc) |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Krista Varady, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
IPD will not be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alternate Day Fasting | These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". |
| FG001 | Exercise | These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. |
| FG002 | 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. 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. |
| FG003 | Control | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adults with obesity and non-alcoholic fatty liver disease
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| ID | Title | Description |
|---|---|---|
| BG000 | Alternate Day Fasting | These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". |
| BG001 | Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hepatic Steatosis | Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF) | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | liver fat percentage | Change from week 1 to week 12 |
|
3 months
The definition of adverse event does not differ from that of of the definitions of clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alternate Day Fasting | These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Varady | University of Illinois Chicago | 3129967897 | varady@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2023 | Sep 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Other | The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. |
|
| Change from week 1 to week 12 |
| Change in Aspartate Aminotransferase (AST) | Measured by a commercial lab (Medstar, Inc) | Change from week 1 to week 12 |
| Change in Fasting Glucose | Measured by a commercial lab (Medstar, Inc) | Change from week 1 to week 12 |
| Change in Fasting Insulin | Measured by a commercial lab (Medstar, Inc) | Change from week 1 to week 12 |
| Change in Insulin Resistance | Measured by Homeostatic model assessment of insulin resistance (HOMA-IR). The HOMA-IR value was calculated using the formula: [HOMA-IR = glucose (mg/dL) × insulin (mU/L)/405]. Interpretation of HOMA-IR Scores: < 1.0: Normal insulin sensitivity; 1.0-1.9: Mild insulin resistance; > 2.0: Moderate to severe insulin resistance. | Change from week 1 to week 12 |
| Change in HbA1c | Measured by a commercial lab (Medstar, Inc) | Change from week 1 to week 12 |
These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. |
| BG002 | 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. 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. |
| BG003 | Control | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. 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. |
| OG003 | Control | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. |
|
|
| Secondary | Change in Body Weight | Measured by digital scale | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | kg | Change from week 1 to week 12 |
|
|
|
| Secondary | Change in Alanine Aminotransferase (ALT) | Measured by a commercial lab (Medstar, Inc) | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | U/L | Change from week 1 to week 12 |
|
|
|
| Secondary | Change in Aspartate Aminotransferase (AST) | Measured by a commercial lab (Medstar, Inc) | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | U/L | Change from week 1 to week 12 |
|
|
|
| Secondary | Change in Fasting Glucose | Measured by a commercial lab (Medstar, Inc) | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | mg/dl | Change from week 1 to week 12 |
|
|
|
| Secondary | Change in Fasting Insulin | Measured by a commercial lab (Medstar, Inc) | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | uIU/mL | Change from week 1 to week 12 |
|
|
|
| Secondary | Change in Insulin Resistance | Measured by Homeostatic model assessment of insulin resistance (HOMA-IR). The HOMA-IR value was calculated using the formula: [HOMA-IR = glucose (mg/dL) × insulin (mU/L)/405]. Interpretation of HOMA-IR Scores: < 1.0: Normal insulin sensitivity; 1.0-1.9: Mild insulin resistance; > 2.0: Moderate to severe insulin resistance. | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | index | Change from week 1 to week 12 |
|
|
|
| Secondary | Change in HbA1c | Measured by a commercial lab (Medstar, Inc) | Adults with obesity and NAFLD | Posted | Mean | 95% Confidence Interval | percentage of glycosylated hemoglobin | Change from week 1 to week 12 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Exercise | These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Control | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |