Alternate Day Fasting and Exercise in Overweight or Obese Adults

NCT ID: NCT03652532

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-10
• Study Completion Date: 2016-03-08

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.

Conditions

Overweight; Obesity; Diet Modification; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Alternate Day Fasting and Exercise

Group Type: EXPERIMENTAL

Alternate Day Fasting

Intervention Type: 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

Intervention Type: 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.

Alternate Day Fasting

Group Type: EXPERIMENTAL

Alternate Day Fasting

Intervention Type: 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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Control

regular eating and exercise habits for 8 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Won Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33512717 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30219052 (View on PubMed)

Other Identifiers

4-2014-0117

Identifier Type: -

Identifier Source: org_study_id