Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss and Cardiometabolic Risk Markers
Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss and Cardiometabolic Risk Markers
Obesity remains a major public health challenge. Intermittent fasting continues to gain
 popularity compared to continuous energy restriction as a weight-loss approach for
 cardiometabolic health. Studies to date comparing intermittent energy restriction (IER) and
 continuous energy restriction (CER) have not been investigated on weight loss and
 cardiometabolic risk markers in low-income countries like Nepal. The main objective of this
 study is to compare the effectiveness of IER versus CER diet on weight loss and
 cardiometabolic risk markers over the course of six months among overweight/obese Nepalese
 population.

 This study will adopt a parallel arm, open-label, randomized control trial design. The study
 duration will be six months from baseline to endline. A total of 112 overweight and obese
 participants, aged 18-64 years, with waist circumference >90 cm (men) and >80 cm (women) will
 be enrolled in the study. Interested participants will be approached through social media and
 consecutively enrolled and assigned to either IER group (n=56) or CER group (n=56) randomly.
 Participants will be provided Mediterranean pattern dietary intervention including two
 groups: IER group will receive 5:2 diet pattern (5 day without energy restriction and 2 days
 with 75% energy restriction, net weekly energy deficit ~25%), and CER group with a
 low-calorie diet (daily energy deficit ~25%) over the course of six months. Both IER and CER
 group will be provided personalized diet plan, portion size, nutrition counseling focus on
 dietary guidance, motivational strategies, and personal goal setting for behavior change with
 educational materials. Baseline data will be collected using a structured questionnaire and
 the biochemical tests will be done. Baseline data will be collected at the time of
 enrollment, midline in three months, and end-line data collection in six months. The primary
 outcome of this study will be the change in weight loss between IER and CER groups. The
 secondary outcome measure will be to evaluate changes in nutritional composition, eating
 behavior, and cardiometabolic risk markers between IER and CER group over six months. Data
 will be entered using Epidata Software and transferred to the Stata/MP version 14.1 for
 further analysis. Data will be analyzed using an intention-to-treat basis. Independent t-test
 and, repeated measures ANOVA will be used to estimate changes between-group comparisons. The
 significance level will be assumed at p<0.05
Overweight and obesity remain a major chronic health problem globally. The development of
 overweight and obesity is associated with various comorbidities including cardiovascular
 disease (CVD), dyslipidemia, hypertension, insulin resistance, certain cancers, and sleep
 apnea. Obesity is a strong modifiable risk factor for CVD, the leading cause of death
 worldwide. Dietary management is a cornerstone in the prevention, treatment, and control of
 overweight and obesity, CVD, and metabolic risk factors. Healthy dietary habits reduce the
 risk of several chronic lifestyle-related diseases as well as meet the demand for essential
 nutrients to the body to keep healthy.

 Many dietary guidelines for the management of overweight and obesity in the general
 population recommended the reduction of body weight through calorie restriction, increase
 energy expenditure or followed both approaches. The most common method of weight loss has
 been daily, or continuous energy restriction (CER), which involves individuals restricting
 their energy restriction on daily basis by anywhere between 15-60%. Although CER is the most
 widely recommended calorie restriction approach for body weight loss and prevention of
 overweight and obesity, recent years have seen a surge in popularity of eating patterns
 including intermittent energy restriction (IER) as an alternative to CER due to its less
 restrictive nature and potential for higher rates of adherence. IER is an alternative weight
 loss method that may prove useful for individuals who find continued energy restriction
 difficult to maintain. Recent studies have shown IER to be comparable to CER in achieving
 weight loss in overweight and obese populations with the mean weight loss being 3-5 kg over
 20 weeks. IER is considered to be effective for the management of obesity because IER
 requires the individual to focus on the energy-restricted for defined days during the week
 which is potentially more feasible than the standard approach of CER which is associated with
 poor compliance, and IER diet pattern have many beneficial metabolic effects achieved with
 weight loss and energy restriction when the person is no undergo negative energy balance.

 Many peoples are worried about their increased body weight due to obesity-related adverse
 outcomes including coronary heart disease, type 2 diabetes, and metabolic disorder. There is
 a knowledge gap of evidence-based dietary patterns used for weight loss diet plan in the
 Nepalese context. The effectiveness IER using a 2-day severe energy-restricted strategy with
 5 days of habitual eating pattern compared to CER has not been yet investigated within the
 Nepalese population. Therefore, the investigators intended to investigate the effectiveness
 of an IER diet using 2-day severe energy-restricted with 5 days of habitual eating pattern
 compared to a CER diet over six months.
Inclusion Criteria:

 -  Men and women aged 18-64 years with body mass index (BMI) 25-40 kg/m2

 -  Waist circumference >90/80 cm (men/women for South and Southeast Asian ethnic
 background) and >1 additional metabolic syndrome component: circulating level of TG
 >1.7 mmol/l, HDL cholesterol <1.0/1.3 (men/women), blood pressure >130/85 mm of Hg or
 use of antihypertensive drugs or fasting glucose >5.6 mmol/l, and weight stability
 within +3 kg during the last three months.

 -  Those who give consent to participate in our intervention study

 Exclusion Criteria:

 -  Those who are pregnant women, lactating women, or planning to become pregnant during
 the course of study.

 -  Those who are severely ill or more than two comorbidities such as major psychiatric
 disorders, previous gastric surgery, haematological disorders, insomnia, Acute
 excerabation of cronic obstructive pulmonary disease, Asthma, respiratorty tract
 infections, and Diabetes patients if treated with insulin or incertin analogues

 -  Those who have any plan to migrate from the study area for at least 6 months

 -  Use of anti-obesity drugs or other drugs affecting body weight

 -  Eating disorder, alcohol or drug abuse that could contribute to difficulties with
 study procedures

 -  Donated blood within three months before the commencement of the study