Alternate Day Fasting and Exercise in Overweight or Obese Adults

August 28, 2018 updated by: Ji-Won Lee, Gangnam Severance Hospital

Effects of Alternate Day Fasting and Exercise on Body Weight, Visceral Fat, and Metabolic Parameters in Overweight or Obese Adults: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
NO_INTERVENTION: Control
regular eating and exercise habits for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: baseline, 8 weeks
body weight (kg)
baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting glucose
Time Frame: baseline, 8 weeks
fasting glucose (mg/dL)
baseline, 8 weeks
Change in insulin
Time Frame: baseline, 8 weeks
insulin (mcIU/mL)
baseline, 8 weeks
Change in triglyceride
Time Frame: baseline, 8 weeks
triglyceride (mg/dL)
baseline, 8 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
Time Frame: baseline, 8 weeks
HDL-cholesterol (mg/dL)
baseline, 8 weeks
Change in visceral fat
Time Frame: baseline, 8 weeks
visceral fat areas (cm2) measured by fat measurement computed tomography (CT)
baseline, 8 weeks
Change in low-density lipoprotein cholesterol (LDL-cholesterol)
Time Frame: baseline, 8 weeks
LDL-cholesterol (mg/dL) calculated using the Friedewald equation
baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 10, 2014

Primary Completion (ACTUAL)

March 8, 2016

Study Completion (ACTUAL)

March 8, 2016

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Alternate Day Fasting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe