Clinical trial NCT01834859: Weight Loss Maintenance and Compensatory Mechanisms Activated With a Very-low Calorie Diet
Official title: How to Optimize Weight Loss Maintenance After a Very-low Calorie Diet?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: weight reduction programs
diet
Caloric restriction
weight loss
weight gain
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse.

The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a "continuous care" intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.

Detailed description: This study included a sub-study (n=30) to determine the timeline over which compensatory mechanisms (at both the level of energy expenditure and appetite control system) are activated with progressive weight loss. Additional measurements were taken at day-3, 5 and 10 % weight loss, and after 4 weeks weight stabilization (after gradually reintroduction of food).

Eligibility criteria: Inclusion Criteria:

* volunteers from Central Norway
* if female: taking oral contraceptives or post-menopausal
* body mass index 30-45 kg/m2
* stable weight (\<2kg variation in the last 3 months)
* not currently dieting to lose weight

Exclusion Criteria:

* Pregnancy
* breast feeding
* drug or alcohol abuse within the last two years
* current medication known to affect appetite or induce weight loss
* enrollment in another obesity treatment program
* history of psychological disorders
* history of eating disorders
* history of diabetes type 1 or 2
* gastrointestinal disorders (particular cholelithiasis)
* kidney -, liver -, lung- or cardiovascular disease
* malignancies

Primary outcomes:
measure: body weight
timeFrame: 1 year (changes from baseline to one year)
Secondary outcomes:
measure: resting metabolic rate, short-term
timeFrame: 10 weeks
measure: appetite, short-term
timeFrame: 10 weeks
measure: exercise efficiency, short-term
timeFrame: 10 weeks
measure: physical activity level, short-term
timeFrame: 10 weeks
measure: resting metabolic rate, long-term
timeFrame: 1 year
measure: appetite, long-term
timeFrame: 1 year
measure: exercise efficiency, long-term
timeFrame: 1 year
measure: physical activity level, long-term
timeFrame: 1 year
measure: Sleep duration and quality
timeFrame: Baseline, end of weigth loss phase and 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Catia Martins, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nymo S, Coutinho SR, Jorgensen J, Rehfeld JF, Truby H, Kulseng B, Martins C. Timeline of changes in appetite during weight loss with a ketogenic diet. Int J Obes (Lond). 2017 Aug;41(8):1224-1231. doi: 10.1038/ijo.2017.96. Epub 2017 Apr 25.
citation: Martins C, Nymo S, Truby H, Rehfeld JF, Hunter GR, Gower BA. Association Between Ketosis and Changes in Appetite Markers with Weight Loss Following a Very Low-Energy Diet. Obesity (Silver Spring). 2020 Dec;28(12):2331-2338. doi: 10.1002/oby.23011.
citation: DeBenedictis JN, Nymo S, Ollestad KH, Boyesen GA, Rehfeld JF, Holst JJ, Truby H, Kulseng B, Martins C. Changes in the Homeostatic Appetite System After Weight Loss Reflect a Normalization Toward a Lower Body Weight. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2538-46. doi: 10.1210/clinem/dgaa202.
citation: Lyngstad A, Nymo S, Coutinho SR, Rehfeld JF, Truby H, Kulseng B, Martins C. Investigating the effect of sex and ketosis on weight-loss-induced changes in appetite. Am J Clin Nutr. 2019 Jun 1;109(6):1511-1518. doi: 10.1093/ajcn/nqz002.
citation: Nymo S, Coutinho SR, Rehfeld JF, Truby H, Kulseng B, Martins C. Physiological Predictors of Weight Regain at 1-Year Follow-Up in Weight-Reduced Adults with Obesity. Obesity (Silver Spring). 2019 Jun;27(6):925-931. doi: 10.1002/oby.22476. Epub 2019 Apr 20.