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Alternate Day Fasting and Exercise in Overweight or Obese Adults

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ClinicalTrials.gov Identifier: NCT03652532
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ji-Won Lee, Gangnam Severance Hospital

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE April 10, 2014
Actual Primary Completion Date March 8, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
Change in body weight [ Time Frame: baseline, 8 weeks ]
body weight (kg)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • Change in visceral fat [ Time Frame: baseline, 8 weeks ]
    visceral fat areas (cm2) measured by fat measurement computed tomography (CT)
  • Change in fasting glucose [ Time Frame: baseline, 8 weeks ]
    fasting glucose (mg/dL)
  • Change in insulin [ Time Frame: baseline, 8 weeks ]
    insulin (mcIU/mL)
  • Change in triglyceride [ Time Frame: baseline, 8 weeks ]
    triglyceride (mg/dL)
  • Change in high-density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: baseline, 8 weeks ]
    HDL-cholesterol (mg/dL)
  • Change in low-density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: baseline, 8 weeks ]
    LDL-cholesterol (mg/dL) calculated using the Friedewald equation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternate Day Fasting and Exercise in Overweight or Obese Adults
Official Title  ICMJE Effects of Alternate Day Fasting and Exercise on Body Weight, Visceral Fat, and Metabolic Parameters in Overweight or Obese Adults: A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Obesity
  • Diet Modification
  • Exercise
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Alternate Day Fasting and Exercise
    Interventions:
    • Behavioral: Alternate Day Fasting
    • Behavioral: Exercise
  • Experimental: Alternate Day Fasting
    Intervention: Behavioral: Alternate Day Fasting
  • Experimental: Exercise
    Intervention: Behavioral: Exercise
  • No Intervention: Control
    regular eating and exercise habits for 8 weeks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 8, 2016
Actual Primary Completion Date March 8, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03652532
Other Study ID Numbers  ICMJE 4-2014-0117
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ji-Won Lee, Gangnam Severance Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gangnam Severance Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gangnam Severance Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP