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Completed

NCT Number: NCT03652532

Alternate Day Fasting and Exercise in Overweight or Obese Adults

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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Key information

Conditions

Overweight Behavior Body Weight Diet Modification Exercise Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternate Day Fasting

Behavioral

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.

Exercise

Behavioral

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 outcomes

  1. Change in body weight

    Time frame: baseline, 8 weeks

    body weight (kg)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2018
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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