Overweight Clinical Trial
Official title:
Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight
Excess ectopic fat deposition is associated with development of cardiovascular and metabolic
diseases. This study investigates how lifestyle interventions can have an effect on different
sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the
clinical and economic value of exercise to supplement a hypocaloric diet is investigated.
Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women
during consultations. Also, recruitment posters will be used in the University Hospital of
Antwerp and the University of Antwerp. Potential participants meeting all a priori set
inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric
diet group (usual care) or a group of hypocaloric diet combined with physical fitness
training. Both groups will undergo an intake procedure in which personal goals are set and
barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by
imaging techniques after three and six months of intervention. Based on the known
relationship between ectopic fat and cardiovascular outcomes, the short term study results
will then be extrapolated to an estimation of the reduction of cardiovascular events.
The following clinical outcomes will be presented: change in ectopic fat in the abdomen
(visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids),
heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The
impact of supervised exercise in addition to diet will be expressed in projected healthcare
costs and quality adjusted life years.
protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87) ;
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