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Alternate Day Fasting and Exercise in Overweight or Obese Adults

Primary Purpose

Overweight, Obesity, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alternate Day Fasting
Exercise
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Alternate Day Fasting and Exercise

    Alternate Day Fasting

    Exercise

    Control

    Arm Description

    regular eating and exercise habits for 8 weeks

    Outcomes

    Primary Outcome Measures

    Change in body weight
    body weight (kg)

    Secondary Outcome Measures

    Change in visceral fat
    visceral fat areas (cm2) measured by fat measurement computed tomography (CT)
    Change in fasting glucose
    fasting glucose (mg/dL)
    Change in insulin
    insulin (mcIU/mL)
    Change in triglyceride
    triglyceride (mg/dL)
    Change in high-density lipoprotein cholesterol (HDL-cholesterol)
    HDL-cholesterol (mg/dL)
    Change in low-density lipoprotein cholesterol (LDL-cholesterol)
    LDL-cholesterol (mg/dL) calculated using the Friedewald equation

    Full Information

    First Posted
    August 28, 2018
    Last Updated
    August 28, 2018
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03652532
    Brief Title
    Alternate Day Fasting and Exercise in Overweight or Obese Adults
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 10, 2014 (Actual)
    Primary Completion Date
    March 8, 2016 (Actual)
    Study Completion Date
    March 8, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Obesity, Diet Modification, Exercise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alternate Day Fasting and Exercise
    Arm Type
    Experimental
    Arm Title
    Alternate Day Fasting
    Arm Type
    Experimental
    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    regular eating and exercise habits for 8 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    Alternate Day Fasting
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in body weight
    Description
    body weight (kg)
    Time Frame
    baseline, 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in visceral fat
    Description
    visceral fat areas (cm2) measured by fat measurement computed tomography (CT)
    Time Frame
    baseline, 8 weeks
    Title
    Change in fasting glucose
    Description
    fasting glucose (mg/dL)
    Time Frame
    baseline, 8 weeks
    Title
    Change in insulin
    Description
    insulin (mcIU/mL)
    Time Frame
    baseline, 8 weeks
    Title
    Change in triglyceride
    Description
    triglyceride (mg/dL)
    Time Frame
    baseline, 8 weeks
    Title
    Change in high-density lipoprotein cholesterol (HDL-cholesterol)
    Description
    HDL-cholesterol (mg/dL)
    Time Frame
    baseline, 8 weeks
    Title
    Change in low-density lipoprotein cholesterol (LDL-cholesterol)
    Description
    LDL-cholesterol (mg/dL) calculated using the Friedewald equation
    Time Frame
    baseline, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33512717
    Citation
    Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
    Results Reference
    derived
    PubMed Identifier
    30219052
    Citation
    Oh M, Kim S, An KY, Min J, Yang HI, Lee J, Lee MK, Kim DI, Lee HS, Lee JW, Jeon JY. Effects of alternate day calorie restriction and exercise on cardio-metabolic risk factors in overweight and obese adults: an exploratory randomized controlled study. BMC Public Health. 2018 Sep 15;18(1):1124. doi: 10.1186/s12889-018-6009-1.
    Results Reference
    derived

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