Clinical trial NCT03652532: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Diet Modification
Exercise
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in body weight
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in visceral fat
timeFrame: baseline, 8 weeks
measure: Change in fasting glucose
timeFrame: baseline, 8 weeks
measure: Change in insulin
timeFrame: baseline, 8 weeks
measure: Change in triglyceride
timeFrame: baseline, 8 weeks
measure: Change in high-density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: baseline, 8 weeks
measure: Change in low-density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
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.