Clinical trial NCT02169778: Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Official title: Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
Intermittent energy restriction
Metabolic compensation
Diet therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Monash University
name: Portuguese Research Council
First posted: 2014-06-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss maintenance and increase the risk of relapse. The aim of this project is to compare the effects of intermittent versus continuous energy restriction on the compensatory responses previously described using two low calory diets, with a similar macronutrient distribution. More specifically, this study will analyze, in the short-term, if an intermittent energy restricted diet is associated with less appetite and low reduction in energy expenditure when compared with a continuous energy restricted diet. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.


Eligibility criteria: Inclusion Criteria:

* adult (18-50 years old)
* obese healthy volunteers (30\<BMI\<40 kg/m2)
* weight stable on the last three months (\<2kg), not currently dieting to lose weight and with an inactive lifestyle

Exclusion Criteria:

* history of endocrine/cardiovascular/pulmonary/kidney disease
* anaemia
* milk intolerance
* depression or other psychological disorders
* eating disorders
* drug or alcohol abuse within the last two years
* current medication known to affect appetite or induce weight loss
* a planned surgery during the study period
* participating in another research study

Primary outcomes:
measure: Appetite related hormones
timeFrame: 12 weeks after the intervention
Secondary outcomes:
measure: Resting metabolic rate (RMR)
timeFrame: 12 weeks after the intervention
measure: Exercise efficiency
timeFrame: 12 weeks after the intervention
measure: Body composition
timeFrame: 12 weeks after the intervention
measure: Body composition
timeFrame: At 6 months from baseline
measure: Body composition
timeFrame: At 1 year from baseline
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bård Kulseng, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Coutinho SR, Halset EH, Gasbakk S, Rehfeld JF, Kulseng B, Truby H, Martins C. Compensatory mechanisms activated with intermittent energy restriction: A randomized control trial. Clin Nutr. 2018 Jun;37(3):815-823. doi: 10.1016/j.clnu.2017.04.002. Epub 2017 Apr 7.
citation: Castela I, Rodrigues C, Ismael S, Barreiros-Mota I, Morais J, Araujo JR, Marques C, Silvestre MP, Angelo-Dias M, Martins C, Borrego LM, Monteiro R, Coutinho SR, Calhau C, Faria A, Pestana D, Martins C, Teixeira D. Intermittent energy restriction ameliorates adipose tissue-associated inflammation in adults with obesity: A randomised controlled trial. Clin Nutr. 2022 Aug;41(8):1660-1666. doi: 10.1016/j.clnu.2022.06.021. Epub 2022 Jun 18.
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.