Alternate Day Fasting and Exercise in Overweight or Obese Adults

Not Applicable

Completed

• Conditions: Diet Modification; Obesity; Overweight; Exercise
• Interventions: Behavioral: Alternate Day Fasting; Behavioral: Exercise

• Registration Number: NCT03652532
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-10
• Primary Completion: 2016-03-08
• Study Completion: 2016-03-08
• Status Verified: 2018-08
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alternate Day Fasting	Alternate Day Fasting	-
Exercise	Exercise	-
Alternate Day Fasting and Exercise	Alternate Day Fasting	-
Alternate Day Fasting and Exercise	Exercise	-

Primary Outcome Measures

Name	Time	Method
Change in body weight	baseline, 8 weeks	body weight (kg)

Secondary Outcome Measures

Name	Time	Method
Change in visceral fat	baseline, 8 weeks	visceral fat areas (cm2) measured by fat measurement computed tomography (CT)
Change in fasting glucose	baseline, 8 weeks	fasting glucose (mg/dL)
Change in insulin	baseline, 8 weeks	insulin (mcIU/mL)
Change in triglyceride	baseline, 8 weeks	triglyceride (mg/dL)
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