Overweight, Obesity, Diet Modification, Exercise
Conditions
Brief summary
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.
Interventions
BEHAVIORALAlternate Day Fasting
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.
BEHAVIORALExercise
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | baseline, 8 weeks | body weight (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting glucose | baseline, 8 weeks | fasting glucose (mg/dL) |
| Change in insulin | baseline, 8 weeks | insulin (mcIU/mL) |
| Change in visceral fat | baseline, 8 weeks | visceral fat areas (cm2) measured by fat measurement computed tomography (CT) |
| Change in high-density lipoprotein cholesterol (HDL-cholesterol) | baseline, 8 weeks | HDL-cholesterol (mg/dL) |
| Change in low-density lipoprotein cholesterol (LDL-cholesterol) | baseline, 8 weeks | LDL-cholesterol (mg/dL) calculated using the Friedewald equation |
| Change in triglyceride | baseline, 8 weeks | triglyceride (mg/dL) |
Outcome results
None listed