Anti-obesity Treatment by Loading in Adult Subjects — ATLAS  

Obesity Clinical Trial

Official title: Effect of Artificial Loading, Through Application of Weight Vests, on Body Weight in Obese Subjects; a Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT04697238
• Study type: Interventional
• Source: Vastra Gotaland Region
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Completion date: February 3, 2022