Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697238
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2020-12-14
Brief Title:
Anti-obesity Treatment by Loading in Adult Subjects
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Effect of Artificial Loading Through Application of Weight Vests on Body Weight in Obese Subjects a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATLAS
Brief 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
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 hoursday for 5 weeks decreases body weight in obese subjects
Secondary objectives
To determine if wearing a weight vest with 11 percent of an individuals 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 individuals 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 11 fashion to either carry a heavy weight vest with 11 percent of the individuals body weight intervention group or a light weight vest with 1 percent of the individuals 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
Primary objective
To determine if wearing a weight vest with 11 percent of body weight for 8 hoursday for 5 weeks decreases body weight in obese subjects
Secondary objectives
To determine if wearing a weight vest with 11 percent of an individuals 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 individuals 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 11 fashion to either carry a heavy weight vest with 11 percent of the individuals body weight intervention group or a light weight vest with 1 percent of the individuals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None