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Clinical Trials in Spain / NCT06619028
Starting soon Not applicable

External Body Weight Effects on Body Weight in Adults With Grade II and III Obesity

NCT06619028 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-10-01
Last updated
2024-10-01

Condition(s) studied

Obesity PreventionObesity

Investigational drug(s) / intervention(s)

Weighted vest

Weighted vest: During the intervention period, the participants will be exposed to an external load, by means of a weighted vest of 10% of their body weight, for a minimum of 8 hours per day for 4 weeks. In the first phase of the study, participants will be followed without changes in their lifestyle as a control. During the intervention they will be instructed to perform their usual activities with the vest, without further alterations in their lifestyle. This will be followed by a 4-week follow-up period without the use of the weighted vest.

Study summary

Obesity is a growing problem in industrialized societies. This condition is associated with an increase in metabolic and cardiovascular diseases. Its cause is multifactorial, influenced by the environment, excessive calorie consumption, insufficient physical activity, sedentary lifestyle and alterations in energy metabolism.

In this context, the hormone leptin, responsible for regulating appetite and body weight, presents resistance in people with obesity, altering the metabolic balance. Recent research has explored the concept of the "gravitostat", a system that responds to the mechanical stimulus of standing upright, as a promising approach in the regulation of body weight. Animal and human studies have shown positive results in weight loss and body recomposition using this system. However, more research is needed to evaluate the clinical applicability and effectiveness of the gravitostat in the management of obesity.

For this reason, the present study is proposed, with a prospective longitudinal controlled design in the use of external body weight (where the patients are their own control: intrasubject controlled study) during 4 weeks, with a previous control period of 4 weeks and a follow-up of 4 weeks. The proposed objectives are to analyze the effectiveness of the use of external weight in the regulation of body weight, body composition and analytical parameters in people with grade II and III obesity. In this way, to analyze the clinical applicability of the gravitostat in the management of patients with this metabolic pathology.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age\>18 years * BMI (≥35) * Compliance at intervention delivery. Exclusion Criteria: * Chronic pathology that may hinder the performance of the intervention * Chronic pain * Regular consumption of pharmacology or supplementation that affects body weight * Inability to perform any physical activity or high risk of suffering adverse effects from the interventibariatric-metabolic surgery * Reduced mobility * Changes of 5kg or more in the last 3 months * Drastic changes in lifestyle habits in the last 3 months (physical activity, eating habits, nicotine or alcohol consumption) * Apparent risk of not being able to complete the study intervention (at the principal investigator\'s discretion) * Pregnancy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
EUGimbernat Sant Cugat del Vallès Barcelona

More Escoles Universitaries Gimbernat trials in Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619028 on ClinicalTrials.gov ↗ ← All trials in Spain