Anti-obesity Treatment by Loading in Adult Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are
      major causes of death in the Western World. This trial may result in improved prevention,
      diagnosis and treatments for obesity and obesity-related disorders. Published data show that
      if a weight is carried by a rodent, this animal will lose body weight and gain an improved
      glucose control. Recently published data further show comparable results in humans when
      carrying an additional weight.

      The investigators aim to confirm and further investigate these findings in humans. The
      investigators plan to let obese participants carry weight vests and monitor their change in
      body weight. The investigators will also measure food intake, physical activity, energy
      expenditure, body composition, abdominal fat and heart rate variability. This to further
      examine the potential beneficial effects of loading and the mechanism of action.
    

Detailed description: 
      STUDY OBJECTIVES AND ENDPOINTS

      Primary objective

      To determine if wearing a weight vest with 11 percent of body weight for 8 hours/day for 5
      weeks decreases body weight in obese subjects.

      Secondary objectives

      To determine if wearing a weight vest with 11 percent of an individual's body weight for up
      to 5 weeks affects levels of abdominal fat, liver fat, fat mass, fat free mass, physical
      activity, energy expenditure, waist circumference, food intake or activity in the autonomic
      nervous system in obese subjects.

      To determine, exploratory, if wearing a weight vest with 11 percent of an individual's body
      weight for up to 5 weeks affects serum concentrations of circulating proteins, metabolites or
      electrolytes in obese subjects.

      STUDY DESIGN AND PROCEDURES

      Overall study design and procedure protocol

      The aim of the study is to investigate the effect of adding artificial weights to individuals
      suffering from obesity. Enrolled study subjects will be randomized in a 1:1 fashion to either
      carry a heavy weight vest with 11 percent of the individual's body weight (intervention
      group) or a light weight vest with 1 percent of the individual's body weight (control group).
      The weight vests will be worn for a total of 5 weeks.

      Body weight, abdominal fat, liver fat, waist circumference, food intake, energy expenditure,
      physical activity, activity in the autonomic nervous system, fat mass, bone mass, water mass
      and fat free mass together with endpoint blood samples will be measured before the start of
      intervention to obtain base line values. New measurements will then be done for comparison
      during or after the intervention to determine the effect of added artificial loading on obese
      subject.

      The study consists of a total of 10 weeks. During the first 3 weeks of the study measurements
      will be made which will be used as baseline. The following 5 weeks contains the intervention
      and the carrying of a weight vest. The last 2 weeks is a follow up period and at the end of
      this period follow up measurements will be done. During or after the intervention period new
      measurements will be made to be compared with the baseline measurements to evaluate the study
      endpoints.

      To avoid the risk of carry-over effects, the investigators have decided to not use a
      crossover design. This could have decreased the variation of the measurement values and
      increased the power of the study. However, the investigators believe there could be a risk of
      a carry-over effect with a cross over design. As this is a completely new effect in clinical
      studies, the investigators have no information about the wash-out time needed to avoid this
      problem.
    

Intervention name(s): Weight vest
Intervention type(s): Device
Intervention description(s): A vest weighing up to a maximum of 15 kg.
Other intervention name(s): Artificial weights
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A parallel study design will be used in which the control group is to be compared with the intervention group. To avoid the risk of carry-over effects, the investigators have decided to not use a crossover design. This could have decreased the variation of the measurement values and increased the power of the study. However, the investigators believe there could be a risk of a carry-over effect with a cross over design. As this is a new effect in clinical studies, the investigators have no information about the wash-out time needed to avoid this problem.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment