NCT03652532

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

August 28, 2018

Last Update Submit

August 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    body weight (kg)

    baseline, 8 weeks

Secondary Outcomes (6)

  • Change in visceral fat

    baseline, 8 weeks

  • Change in fasting glucose

    baseline, 8 weeks

  • Change in insulin

    baseline, 8 weeks

  • Change in triglyceride

    baseline, 8 weeks

  • Change in high-density lipoprotein cholesterol (HDL-cholesterol)

    baseline, 8 weeks

  • +1 more secondary outcomes

Study Arms (4)

Alternate Day Fasting and Exercise

EXPERIMENTAL
Behavioral: Alternate Day FastingBehavioral: Exercise

Alternate Day Fasting

EXPERIMENTAL
Behavioral: Alternate Day Fasting

Exercise

EXPERIMENTAL
Behavioral: Exercise

Control

NO INTERVENTION

regular eating and exercise habits for 8 weeks

Interventions

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.

Alternate Day FastingAlternate Day Fasting and Exercise
ExerciseBEHAVIORAL

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.

Alternate Day Fasting and ExerciseExercise

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 29, 2018

Study Start

April 10, 2014

Primary Completion

March 8, 2016

Study Completion

March 8, 2016

Last Updated

August 29, 2018

Record last verified: 2018-08