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Alternate Day Fasting and Exercise in Overweight or Obese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Diet Modification Exercise Behavioral: Alternate Day Fasting Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 10, 2014
Actual Primary Completion Date : March 8, 2016
Actual Study Completion Date : March 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alternate Day Fasting and Exercise 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.

Experimental: Alternate Day Fasting 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.

Experimental: Exercise 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.

No Intervention: Control
regular eating and exercise habits for 8 weeks



Primary Outcome Measures :
  1. Change in body weight [ Time Frame: baseline, 8 weeks ]
    body weight (kg)


Secondary Outcome Measures :
  1. Change in visceral fat [ Time Frame: baseline, 8 weeks ]
    visceral fat areas (cm2) measured by fat measurement computed tomography (CT)

  2. Change in fasting glucose [ Time Frame: baseline, 8 weeks ]
    fasting glucose (mg/dL)

  3. Change in insulin [ Time Frame: baseline, 8 weeks ]
    insulin (mcIU/mL)

  4. Change in triglyceride [ Time Frame: baseline, 8 weeks ]
    triglyceride (mg/dL)

  5. Change in high-density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: baseline, 8 weeks ]
    HDL-cholesterol (mg/dL)

  6. Change in low-density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: baseline, 8 weeks ]
    LDL-cholesterol (mg/dL) calculated using the Friedewald equation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ji-Won Lee, Associate Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03652532    
Other Study ID Numbers: 4-2014-0117
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms