Alternate Day Fasting and Exercise in Overweight or Obese Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652532
• Other study ID #: 4-2014-0117
• Status: Completed
• Phase: N/A
• Start date: April 10, 2014
• Est. completion date: March 8, 2016

Study information

• Verified date: August 2018
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 8, 2016
• Est. primary completion date: March 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Exercise
• Obesity
• Overweight

Intervention

Behavioral:
• Alternate 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.
• Exercise
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	body weight (kg)	baseline, 8 weeks
Secondary	Change in visceral fat	visceral fat areas (cm2) measured by fat measurement computed tomography (CT)	baseline, 8 weeks
Secondary	Change in fasting glucose	fasting glucose (mg/dL)	baseline, 8 weeks
Secondary	Change in insulin	insulin (mcIU/mL)	baseline, 8 weeks
Secondary	Change in triglyceride	triglyceride (mg/dL)	baseline, 8 weeks
Secondary	Change in high-density lipoprotein cholesterol (HDL-cholesterol)	HDL-cholesterol (mg/dL)	baseline, 8 weeks
Secondary	Change in low-density lipoprotein cholesterol (LDL-cholesterol)	LDL-cholesterol (mg/dL) calculated using the Friedewald equation	baseline, 8 weeks