Overweight and ObesityNCT04526847
Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss
A study testing Intermittent energy restriction (IER) : 5:2 diet pattern and Continuous energy restricted (CER) group in people with Overweight and Obesity, run by Armed Police Force Hospital, Nepal at 1 site in Nepal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Intermittent energy restriction (IER) : 5:2 diet pattern and Continuous energy restricted (CER) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 years or above with body mass index (BMI) >25 kg/m2
- Those who give consent to participate in our intervention study
Who cannot join
- 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 chronic obstructive pulmonary disease, asthma, respiratorty tract infections, and diabetes patients if treated with insulin or hypoglycemic agents.
- Those who have any plan to migrate from the study area for at least three 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
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Dev Ram Sunuwar
Kathmandu, Bagmati, +977
Dev Ram Mr. Sunuwar, M.Sc, +977-9851147339, devramsunuwar@gmail.com
Pranil Man Singh Dr. Pradhan, MD, +977-9841238435, pranil.pradhan@gmail.com
About this study
Official title: Effectiveness of Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss Among Overweight/Obese Adults: a Randomized Controlled Trial
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
Read the detailed description
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.
- Conditions
- Overweight and Obesity
- Being tested
- Intermittent energy restriction (IER) : 5:2 diet pattern, Continuous energy restricted (CER) group
- Keywords
- Intermittent fasting, energy restriction, weight loss, cardiometabolic risk markers, Nepal
- Medical subject headings
- Overweight, Obesity, Intermittent Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent energy restriction (IER) : 5:2 diet patternBehavioural
Also called Intermittent fasting
Participants in the IER group will be provided menus on fasting day that provide ~25% of the individual energy requirement (400 kcal/day for females and 600 kcal/day for males) that means ~75% energy restriction per week (Sundfør et al., 2018; Svendsen, 2018; Templeman, Gonzalez, Thompson, \& Betts, 2020). The recommended fasting day may be on two non-consecutive days (Mondays and Thursdays) per week and remaining five days of the week will be based on the usual diet plan. All participants will be instructed to complete all food by 12 pm and then fast until 8 am the following day (Svendsen, 2018).Thus, the weekly average calorie intake will correspond to ~75% of the normal energy requirements. They will receive a diet plan that recommended ~50 gm protein/day from chicken breast, lean meat, lean fish, fat-free yogurt, cottage cheese, egg or legumes, and vegetables to increase satiety on fasting days.
Continuous energy restricted (CER) groupBehavioural
Also called low calorie diet
Participants in the CER group will be advised to reduce total energy intake to 1200-1550 kcal in all seven days a week. They will be provided diet plan calculated in relation to each person's estimated energy requirements. Menus will be divided into breakfast, lunch, dinner, and snacks in line with their individualized energy recommendations. They will be requested to consume ~75% of the individual energy requirements daily (25% energy restriction of calculated baseline energy requirements daily) over six months. Thus, the overall energy restriction will similar between the groups at an estimated reduction of 25% of requirements. Participants will be randomized in a 1:1 ratio, and assigned to an intermittent or continuous energy restriction group randomly.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intermittent energy restricted (IER) group:
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%) Receives: Behavioral: Intermittent energy restriction (IER) : 5:2 diet pattern; Behavioral: Continuous energy restricted (CER) group |
| Calorie Restricted Diet (CER) | Active comparator | Continuous energy restricted (CER) group:
CER group with a low-calorie diet (daily energy deficit ~25%) over the course of six months. Receives: Behavioral: Intermittent energy restriction (IER) : 5:2 diet pattern; Behavioral: Continuous energy restricted (CER) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body weight
The primary outcome of this study will be the change in reduction of body weight between IER diet using 2-day severe energy-restricted with 5 days of habitual eating pattern compared to a CER diet over three months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Apr 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a parallel arm, randomized controlled trial compare two different dietary patterns: 1) intermittent energy-restriction (IER) diet also known as intermittent fasting (5:2 eating pattern: 5 days of habitual intake and 2 very low energy diet on two non-consecutive days (Mondays and Thursdays) per week, and 2) Continuous (daily) energy-restricted diet (CER) on the reduction of body weight, and cardiometabolic risk factors among overweight/obese Nepalese population (Figure 2). This study will adopt a parallel randomized trial design with an equal allocation of participants between the IER and CER arm. The participants will be recruited from the general population through social media advertisements. The study will be carried out for six months, from baseline data collection, follow-up midline data collection, and end-line data collection for outcome measure.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Police Force Hospital, Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dev Ram Sunuwar, Armed Police Force Hospital, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526847
- Sponsor's protocol ID
- Intermittent Fasting
- Status last verified
- Mar 2023
- First submitted
- 19 Aug 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a study protocol, so we don't have any data yet.
Publications
Templeman I, Gonzalez JT, Thompson D, Betts JA. The role of intermittent fasting and meal timing in weight management and metabolic health. Proc Nutr Soc. 2020 Feb;79(1):76-87. doi: 10.1017/S0029665119000636. Epub 2019 Apr 26.
PubMed 31023390Sundfor TM, Svendsen M, Tonstad S. Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial. Nutr Metab Cardiovasc Dis. 2018 Jul;28(7):698-706. doi: 10.1016/j.numecd.2018.03.009. Epub 2018 Mar 29.
PubMed 29778565Pinto AM, Bordoli C, Buckner LP, Kim C, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL. Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study. Clin Nutr. 2020 Jun;39(6):1753-1763. doi: 10.1016/j.clnu.2019.07.014. Epub 2019 Jul 30.
PubMed 31409509Sundfor TM, Tonstad S, Svendsen M. Effects of intermittent versus continuous energy restriction for weight loss on diet quality and eating behavior. A randomized trial. Eur J Clin Nutr. 2019 Jul;73(7):1006-1014. doi: 10.1038/s41430-018-0370-0. Epub 2018 Dec 4.
PubMed 30514879Poirier P, Giles TD, Bray GA, Hong Y, Stern JS, Pi-Sunyer FX, Eckel RH; American Heart Association; Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Obesity and cardiovascular disease: pathophysiology, evaluation, and effect of weight loss: an update of the 1997 American Heart Association Scientific Statement on Obesity and Heart Disease from the Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2006 Feb 14;113(6):898-918. doi: 10.1161/CIRCULATIONAHA.106.171016. Epub 2005 Dec 27.
PubMed 16380542Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.
PubMed 31614992Schubel R, Nattenmuller J, Sookthai D, Nonnenmacher T, Graf ME, Riedl L, Schlett CL, von Stackelberg O, Johnson T, Nabers D, Kirsten R, Kratz M, Kauczor HU, Ulrich CM, Kaaks R, Kuhn T. Effects of intermittent and continuous calorie restriction on body weight and metabolism over 50 wk: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):933-945. doi: 10.1093/ajcn/nqy196.
PubMed 30475957Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.
PubMed 26641646Seimon RV, Roekenes JA, Zibellini J, Zhu B, Gibson AA, Hills AP, Wood RE, King NA, Byrne NM, Sainsbury A. Do intermittent diets provide physiological benefits over continuous diets for weight loss? A systematic review of clinical trials. Mol Cell Endocrinol. 2015 Dec 15;418 Pt 2:153-72. doi: 10.1016/j.mce.2015.09.014. Epub 2015 Sep 16.
PubMed 26384657Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
PubMed 23591120Antoni R, Johnston KL, Collins AL, Robertson MD. Intermittent v. continuous energy restriction: differential effects on postprandial glucose and lipid metabolism following matched weight loss in overweight/obese participants. Br J Nutr. 2018 Mar;119(5):507-516. doi: 10.1017/S0007114517003890.
PubMed 29508693Carter S, Clifton PM, Keogh JB. The effects of intermittent compared to continuous energy restriction on glycaemic control in type 2 diabetes; a pragmatic pilot trial. Diabetes Res Clin Pract. 2016 Dec;122:106-112. doi: 10.1016/j.diabres.2016.10.010. Epub 2016 Oct 19.
PubMed 27833048Harvie M, Howell A. Potential Benefits and Harms of Intermittent Energy Restriction and Intermittent Fasting Amongst Obese, Overweight and Normal Weight Subjects-A Narrative Review of Human and Animal Evidence. Behav Sci (Basel). 2017 Jan 19;7(1):4. doi: 10.3390/bs7010004.
PubMed 28106818
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss Among Overweight/Obese Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04526847
- Acronym / sponsor ID
- Intermittent Fasting
- Conditions
- Overweight and Obesity
- Keywords
- Intermittent fasting, energy restriction, weight loss, cardiometabolic risk markers, Nepal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Armed Police Force Hospital, NepalOther government
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study is a parallel arm, randomized controlled trial compare two different dietary patterns: 1) intermittent energy-restriction (IER) diet also known as intermittent fasting (5:2 eating pattern: 5 days of habitual intake and 2 very low energy diet on two non-consecutive days (Mondays and Thursdays) per week, and 2) Continuous (daily) energy-restricted diet (CER) on the reduction of body weight, and cardiometabolic risk factors among overweight/obese Nepalese population (Figure 2). This study will adopt a parallel randomized trial design with an equal allocation of participants between the IER and CER arm. The participants will be recruited from the general population through social media advertisements. The study will be carried out for six months, from baseline data collection, follow-up midline data collection, and end-line data collection for outcome measure.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intermittent energy restriction (IER) : 5:2 diet pattern, Behavioral: Continuous energy restricted (CER) groupIntermittent energy restricted (IER) group: 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%) |
| Calorie Restricted Diet (CER) | Active comparator | Behavioral: Intermittent energy restriction (IER) : 5:2 diet pattern, Behavioral: Continuous energy restricted (CER) groupContinuous energy restricted (CER) group: CER group with a low-calorie diet (daily energy deficit ~25%) over the course of six months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women aged 18 years or above with body mass index (BMI) >25 kg/m2
- Those who give consent to participate in our intervention study
Key exclusion criteria (5 listed)
- 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 chronic obstructive pulmonary disease, asthma, respiratorty tract infections, and diabetes patients if treated with insulin or hypoglycemic agents.
- Those who have any plan to migrate from the study area for at least three 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent energy restriction (IER) : 5:2 diet patternAlso: Intermittent fastingParticipants in the IER group will be provided menus on fasting day that provide ~25% of the individual energy requirement (400 kcal/day for females and 600 kcal/day for males) that means ~75% energy restriction per week (Sundfør et al., 2018; Svendsen, 2018; Templeman, Gonzalez, Thompson, \& Betts, 2020). The recommended fasting day may be on two non-consecutive days (Mondays and Thursdays) per week and remaining five days of the week will be based on the usual diet plan. All participants will be instructed to complete all food by 12 pm and then fast until 8 am the following day (Svendsen, 2018).Thus, the weekly average calorie intake will correspond to ~75% of the normal energy requirements. They will receive a diet plan that recommended ~50 gm protein/day from chicken breast, lean meat, lean fish, fat-free yogurt, cottage cheese, egg or legumes, and vegetables to increase satiety on fasting days. | Behavioural | Calorie Restricted Diet (CER), Intervention |
| Continuous energy restricted (CER) groupAlso: low calorie dietParticipants in the CER group will be advised to reduce total energy intake to 1200-1550 kcal in all seven days a week. They will be provided diet plan calculated in relation to each person's estimated energy requirements. Menus will be divided into breakfast, lunch, dinner, and snacks in line with their individualized energy recommendations. They will be requested to consume ~75% of the individual energy requirements daily (25% energy restriction of calculated baseline energy requirements daily) over six months. Thus, the overall energy restriction will similar between the groups at an estimated reduction of 25% of requirements. Participants will be randomized in a 1:1 ratio, and assigned to an intermittent or continuous energy restriction group randomly. | Behavioural | Calorie Restricted Diet (CER), Intervention |
Primary outcome
Change in Body weight
Time frame: 3 months
The primary outcome of this study will be the change in reduction of body weight between IER diet using 2-day severe energy-restricted with 5 days of habitual eating pattern compared to a CER diet over three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 31023390Templeman I, Gonzalez JT, Thompson D, Betts JA. The role of intermittent fasting and meal timing in weight management and metabolic health. Proc Nutr Soc. 2020 Feb;79(1):76-87. doi: 10.1017/S0029665119000636. Epub 2019 Apr 26.
- Results publication: PubMed 29778565Sundfor TM, Svendsen M, Tonstad S. Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial. Nutr Metab Cardiovasc Dis. 2018 Jul;28(7):698-706. doi: 10.1016/j.numecd.2018.03.009. Epub 2018 Mar 29.
- Results publication: PubMed 31409509Pinto AM, Bordoli C, Buckner LP, Kim C, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL. Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study. Clin Nutr. 2020 Jun;39(6):1753-1763. doi: 10.1016/j.clnu.2019.07.014. Epub 2019 Jul 30.
- Results publication: PubMed 30514879Sundfor TM, Tonstad S, Svendsen M. Effects of intermittent versus continuous energy restriction for weight loss on diet quality and eating behavior. A randomized trial. Eur J Clin Nutr. 2019 Jul;73(7):1006-1014. doi: 10.1038/s41430-018-0370-0. Epub 2018 Dec 4.
- Results publication: PubMed 16380542Poirier P, Giles TD, Bray GA, Hong Y, Stern JS, Pi-Sunyer FX, Eckel RH; American Heart Association; Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Obesity and cardiovascular disease: pathophysiology, evaluation, and effect of weight loss: an update of the 1997 American Heart Association Scientific Statement on Obesity and Heart Disease from the Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2006 Feb 14;113(6):898-918. doi: 10.1161/CIRCULATIONAHA.106.171016. Epub 2005 Dec 27.
- Results publication: PubMed 31614992Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.
- Results publication: PubMed 30475957Schubel R, Nattenmuller J, Sookthai D, Nonnenmacher T, Graf ME, Riedl L, Schlett CL, von Stackelberg O, Johnson T, Nabers D, Kirsten R, Kratz M, Kauczor HU, Ulrich CM, Kaaks R, Kuhn T. Effects of intermittent and continuous calorie restriction on body weight and metabolism over 50 wk: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):933-945. doi: 10.1093/ajcn/nqy196.
- Results publication: PubMed 26641646Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.
- Results publication: PubMed 26384657Seimon RV, Roekenes JA, Zibellini J, Zhu B, Gibson AA, Hills AP, Wood RE, King NA, Byrne NM, Sainsbury A. Do intermittent diets provide physiological benefits over continuous diets for weight loss? A systematic review of clinical trials. Mol Cell Endocrinol. 2015 Dec 15;418 Pt 2:153-72. doi: 10.1016/j.mce.2015.09.014. Epub 2015 Sep 16.
- Results publication: PubMed 23591120Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
- Results publication: PubMed 29508693Antoni R, Johnston KL, Collins AL, Robertson MD. Intermittent v. continuous energy restriction: differential effects on postprandial glucose and lipid metabolism following matched weight loss in overweight/obese participants. Br J Nutr. 2018 Mar;119(5):507-516. doi: 10.1017/S0007114517003890.
- Results publication: PubMed 27833048Carter S, Clifton PM, Keogh JB. The effects of intermittent compared to continuous energy restriction on glycaemic control in type 2 diabetes; a pragmatic pilot trial. Diabetes Res Clin Pract. 2016 Dec;122:106-112. doi: 10.1016/j.diabres.2016.10.010. Epub 2016 Oct 19.
- Individual participant dataSharing planned: No. This is a study protocol, so we don't have any data yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent energy restriction (IER) : 5:2 diet pattern and Continuous energy restricted (CER) group in people with Overweight and Obesity, run by Armed Police Force Hospital, Nepal at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526847, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.