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CompletedNCT03652532Updated Aug 29, 2018

Alternate Day Fasting and Exercise in Overweight or Obese Adults

An interventional study of Alternate Day Fasting and Exercise in Overweight, Obesity and Diet Modification, sponsored by Gangnam Severance Hospital. Completed. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Apr 2014, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Overweight
  • Obesity
  • Diet Modification
  • Exercise

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Alternate Day Fasting and Exercise

    Behavioral: Alternate Day Fasting · Behavioral: Exercise

  • Experimental
    Alternate Day Fasting

    Behavioral: Alternate Day Fasting

  • Experimental
    Exercise

    Behavioral: Exercise

  • No intervention
    Control

    regular eating and exercise habits for 8 weeks

Interventions

  • BehavioralAlternate 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.

  • BehavioralExercise

    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.

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What researchers measure

Primary outcomes

  1. Change in body weight

    body weight (kg)

    Time frame: baseline, 8 weeks

Secondary outcomes

  1. Change in visceral fat

    visceral fat areas (cm2) measured by fat measurement computed tomography (CT)

    Time frame: baseline, 8 weeks

  2. Change in fasting glucose

    fasting glucose (mg/dL)

    Time frame: baseline, 8 weeks

  3. Change in insulin

    insulin (mcIU/mL)

    Time frame: baseline, 8 weeks

  4. Change in triglyceride

    triglyceride (mg/dL)

    Time frame: baseline, 8 weeks

  5. Change in high-density lipoprotein cholesterol (HDL-cholesterol)

    HDL-cholesterol (mg/dL)

    Time frame: baseline, 8 weeks

  6. Change in low-density lipoprotein cholesterol (LDL-cholesterol)

    LDL-cholesterol (mg/dL) calculated using the Friedewald equation

    Time frame: baseline, 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 33512717 ↗
  • 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. PubMed 30219052 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03652532
Lead sponsor
Gangnam Severance Hospital
Responsible party
Ji-Won Lee (Associate Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Aug 29, 2018
Start date
Apr 10, 2014
Primary completion
Mar 8, 2016
Completion
Mar 8, 2016
Last update
Aug 29, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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