Clinical trial NCT01912742: Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction
Official title: Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
Speed of weight loss
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: 2013-07-31
Enrollment: 35
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 (WL) 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 WL maintenance and increase the risk of relapse. The aim of this project is to investigate the potential role of WL rate in modulating such responses. More specifically, the investigators want to determine if a similar WL achieved rapidly vs slowly induce the same compensatory responses to weight reduction. A secondary aim is to assess if speed of weight loss can influence motivation. A large battery of assessments will be performed before and after weight reduction including body composition, resting metabolic rate, substrate oxidation, exercise efficiency, fasting and postprandial release of several appetite-regulating hormones, subjective feelings of hunger and fullness and motivation. 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\<45 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, gout, milk intolerance, depression or other psychological disorders, eating disorders, drug or alcohol abuse within the last two years and current medication known to affect appetite or induce weight loss. Those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study

Primary outcomes:
measure: Appetite related hormones
timeFrame: Before the start of the study and again at week 2 and 4 (VLCD group) and 4 and 8 (LCD group). And also, on week 12 (for both groups).
measure: Body composition
timeFrame: Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)
Secondary outcomes:
measure: Resting metabolic rate (RMR)
timeFrame: Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)
measure: Exercise efficiency
timeFrame: Baseline, 2 and 4 weeks (VLCD group) and 4 and 8 weeks (LCD group) and 12 weeks (both groups)
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
affiliation: Norwegian University of Science and Technology
name: Catia Martins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coutinho SR, With E, Rehfeld JF, Kulseng B, Truby H, Martins C. The impact of rate of weight loss on body composition and compensatory mechanisms during weight reduction: A randomized control trial. Clin Nutr. 2018 Aug;37(4):1154-1162. doi: 10.1016/j.clnu.2017.04.008. Epub 2017 Apr 25.