Alternate Day Fasting and Exercise in Overweight or Obese Adults

Study Overview
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Brief Summary
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Alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. However, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in Korea. The purpose of this randomized clinical trial is to examine the effects of alternate day fasting and exercise on weight reduction, visceral fat, and metabolic parameters in overweight or obese adults.

Official Title
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Effects of Alternate Day Fasting and Exercise on Body Weight, Visceral Fat, and Metabolic Parameters in Overweight or Obese Adults: A Randomized Controlled Trial

Conditions
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Overweight, Obesity, Diet Modification, Exercise

Intervention / Treatment
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* Behavioral: Alternate Day Fasting
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-65 years Body mass index (BMI) more than 23.0 kg/m² (overweight or obese for Asian populations, according to the World Health Organization) Exclusion Criteria: Participants with weight gain more than 5kg in the last 3 months Participants with history of bariatric surgery Participants with secondary obesity, such as hypothyroidism Participants with uncontrolled hypertension or type 1 diabetes Participants who are taking anti-diabetic medications due to type 2 diabetes Participants with hepatic disease (AST or ALT ≥200 mg/dL) Participants with renal disease (serum creatinine ≥2.0 mg/dL) Participants with pancreatitis or related disorders Participants with acute infectious diseases (i.e., pneumonia, acute enteritis, or urinary infection) Participants with chronic inflammatory diseases (i.e., rheumatoid arthritis, or lupus) Participants with overeating behavior Participants with history of cardiovascular diseases Participants with history of cancer Participants who are taking anti-obesity, anti-diabetic, diuretic, central-nervous system, antidepressant, antipsychotic, or steroid medications Pregnant or lactating women Participants who intake more than 30 g of alcohol daily Night-time or shift-work workers Participants with chronic malabsorption syndrome or cholestasis Participants with other medical conditions that would preclude subjects from participating in exercise and physical test

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternate Day Fasting and Exercise<br> | Behavioral: Alternate Day Fasting<br>* During the 8-week intervention, participants consumed 25% of their daily recommended energy intake (approximately 500 kcal) on each fast day (24 h), and consumed food ad libitum on each feed day (24 h). The fast day and feed day were repeated every other day, and the fast day occurred 3 days per week.<br>Behavioral: Exercise<br>* During the 8-week intervention, participants visited the research center gym at least three times per week and received exercise logs. Each exercise session began with 5 minutes of warm-up and ended with 5 minutes of cool-down. Resistance training was performed using weight training machines, barbells, and dumbbells for 40 minutes. Aerobic exercise was performed on motorized treadmills for 20 minutes.<br>|
| Experimental: Alternate Day Fasting<br> | Behavioral: Alternate Day Fasting<br>* During the 8-week intervention, participants consumed 25% of their daily recommended energy intake (approximately 500 kcal) on each fast day (24 h), and consumed food ad libitum on each feed day (24 h). The fast day and feed day were repeated every other day, and the fast day occurred 3 days per week.<br>|
| Experimental: Exercise<br> | Behavioral: Exercise<br>* During the 8-week intervention, participants visited the research center gym at least three times per week and received exercise logs. Each exercise session began with 5 minutes of warm-up and ended with 5 minutes of cool-down. Resistance training was performed using weight training machines, barbells, and dumbbells for 40 minutes. Aerobic exercise was performed on motorized treadmills for 20 minutes.<br>|
| No Intervention: Control<br>regular eating and exercise habits for 8 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | body weight (kg) | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral fat | visceral fat areas (cm2) measured by fat measurement computed tomography (CT) | baseline, 8 weeks | 
| Change in fasting glucose | fasting glucose (mg/dL) | baseline, 8 weeks | 
| Change in insulin | insulin (mcIU/mL) | baseline, 8 weeks | 
| Change in triglyceride | triglyceride (mg/dL) | baseline, 8 weeks | 
| Change in high-density lipoprotein cholesterol (HDL-cholesterol) | HDL-cholesterol (mg/dL) | baseline, 8 weeks | 
| Change in low-density lipoprotein cholesterol (LDL-cholesterol) | LDL-cholesterol (mg/dL) calculated using the Friedewald equation | baseline, 8 weeks |