ObesityATLASNCT04697238
Anti-obesity Treatment by Loading in Adult Subjects
A study testing Weight vest in people with Obesity, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent to participate in the study.
- Consent out of free will.
- 18-65 years of age.
- Obesity as defined by a BMI >30 and ≤35. Fat mass > 25 %.
- Willingness to comply with the study protocol
- Normal or clinically non-significant screening of blood samples:
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- Hemoglobin (Hb), White Blood Cell Count (WBC), thrombocyte count, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), creatinine, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, Prothrombin Time (PT-INR), Activated Partial Thromboplastin Time (APTT), human immunodeficiency viruses (HIV), Hepatitis B, Hepatitis C, glycated hemoglobin (HbA1c), C-reactive protein (CRP), free thyroxine (fT4), thyroid-stimulating hormone (TSH).
- Normal or clinically non-significant aberrations of screening blood samples are defined as:
- Normal: Values within the reference interval supplied by the local lab at Sahlgrenska University Hospital
- Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)
- Normal or non-clinically significant 12-lead electrocardiography (ECG) recording as judged by the investigator.
Who cannot join
- Chronic disease that could interfere with the participation in the study as judged by the investigator. For example poorly regulated type 1 or 2 diabetes, severe cardiovascular disease that effect daily life, severe pulmonary disease that affects daily life or malignancy.
- Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip and knee pain.
- Regular consumption of medicine or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted:
- β-blockers, Glucagon-like peptide-1 (GLP-1) agonists, Dipeptidyl peptidase-4 (DPP-IV) inhibitors, SGLT2-inhibitors, sulfonylureas, insulin, orlistat, anti-obesity drugs, antidepressants, bisphosphonates, β2-agonists, oral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.
- Any illegal drugs according to local laws and regulation
- Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
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- Reduced mobility.
- Pregnancy. Females of childbearing potential must confirm to use reliable contraception (intrauterine device, oral contraceptives or condom) and not suspect to be pregnant. Pregnancy test will be taken on all female subjects of fertile age unless permanently sterile, as judged by the investigator. Permanently sterile women can be excluded from the pregnancy test. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
- Change in body weight of 5 kg or greater during the past 3 months or recently started a strict diet. Also, a greater change in body weight than 4 kg difference between day -21 and day 0 will not be accepted.
- Use of any illegal drugs according to local regulations or consuming excessive amounts of alcohol, tobacco, nicotine.
- Excessive amounts of above-mentioned substances defined as:
- Consumption of more than 9 glasses of wine for women, 14 glasses of wine for men (15 cl/glass 11 % alcohol) or equivalent as judged by investigator during an ordinary week will not be accepted.
- Individuals with a consumption equal or higher than 10 cigarettes or half a packet of snuff per day.
- Drastic change in lifestyle during the last 3 months; for example a significant change in physical activity, dietary habits, nicotine, alcohol or drug use as judged by the investigator.
- Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
- Having participated in a similar study during the last 6 months.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Trial Center, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 405 30
About this study
Official title: Effect of Artificial Loading, Through Application of Weight Vests, on Body Weight in Obese Subjects; a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Weight vest
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight vestDevice
Also called Artificial weights
A vest weighing up to a maximum of 15 kg.
| Study group | Role | What they receive |
|---|---|---|
| High load (11 % of body weight vests) | Experimental | Subjects in this arm will carry heavy weight (11 percent of body weight) vests for 5 weeks. Receives: Device: Weight vest |
| Low load (1 % of body weight vests) | Placebo comparator | Subjects in this arm will carry heavy weight (1 percent of body weight) vests for 5 weeks. Receives: Device: Weight vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight at 5 weeks
Change in body weight (in percent of baseline body weight) between day 35 and baseline in the high load group compared with low load group.
Measured: 35 days
Secondary outcomes (10)
Change in body weight at 15 days
Change in body weight between day 15 and baseline measured in grams.
Measured: 15 days
Change in subcutaneous fat at 35 days
Change in levels of subcutaneous fat between day 35 and baseline measured in cm^2 from CT images of the abdomen.
Measured: 35 days
Change in visceral fat at 35 days
Change in levels of visceral fat between day 35 and baseline measured in cm^2 from CT images of the abdomen.
Measured: 35 days
Change in liver fat at 35 days
Change in levels of liver fat between day 35 and baseline measured in Hounsfield Units (HU) from CT images of the abdomen.
Measured: 35 days
Change in body composition at 35 days
Change in levels of fat mass and fat free mass between day 35 and baseline measured in grams with Dual-energy X-ray absorptiometry (DXA).
Measured: 35 days
Change in waist circumference at 35 days
Change in waist circumference between day 35 and baseline measured in centimeters with measuring tape.
Measured: 35 days
Change in physical activity at 21 days
Change in physical activity between day 21 and baseline. Measured as time distribution in a spectrum of physical activity intensities assessed by accelerometer worn for 24 hours a day for one week. Change measured in minutes per day. Changes compared between measurements during intervention (day 15 to 21) and baseline (day -13 to -7).
Measured: 21 days
Change in energy expenditure at 28 days
Change in energy expenditure between day 28 and baseline measured in joules per day with the doubly labeled water method. Changes compared between measurement during intervention (day 14 to 28) and baseline (day -14 to 0).
Measured: 28 days
Change in food intake at 28 days
Change in food intake between day 28 and baseline measured in calories with the validated questionnaire Short Dietary Questionnaire (SDQ). Changes compared between measurement during intervention (day 14 to 28) and baseline (day -14 to 0).
Measured: 28 days
Change in autonomic nervous system activity at 15 days
Change in heart rate variability (HRV) between day 15 and baseline measured in milliseconds with 24-hour electrocardiography (ECG) monitoring. Changes measured at day 15 compared with baseline (day -13).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Sep 2021
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Dan Curiac, Principal investigator, Clinical Trial Center, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697238
- Sponsor's protocol ID
- ATLAS
- Acronym
- ATLAS
- Status last verified
- Apr 2021
- First submitted
- 14 Dec 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jansson JO, Palsdottir V, Hagg DA, Schele E, Dickson SL, Anesten F, Bake T, Montelius M, Bellman J, Johansson ME, Cone RD, Drucker DJ, Wu J, Aleksic B, Tornqvist AE, Sjogren K, Gustafsson JA, Windahl SH, Ohlsson C. Body weight homeostat that regulates fat mass independently of leptin in rats and mice. Proc Natl Acad Sci U S A. 2018 Jan 9;115(2):427-432. doi: 10.1073/pnas.1715687114. Epub 2017 Dec 26.
PubMed 29279372Ohlsson C, Gidestrand E, Bellman J, Larsson C, Palsdottir V, Hagg D, Jansson PA, Jansson JO. Increased weight loading reduces body weight and body fat in obese subjects - A proof of concept randomized clinical trial. EClinicalMedicine. 2020 Apr 30;22:100338. doi: 10.1016/j.eclinm.2020.100338. eCollection 2020 May.
PubMed 32510046Bellman J, Westerterp K, Wouters L, Johannesson M, Lundqvist N, Kullberg J, Larsson C, Gustafsson M, Pettersson S, Fridolfsson J, Arvidsson D, Borjesson M, Curiac D, Jansson JO, Jansson PA, Ohlsson C. Increased weight-load improves body composition by reducing fat mass and waist circumference, and by increasing lean mass in participants with obesity: a single-centre randomised controlled trial. BMC Med. 2025 May 30;23(1):317. doi: 10.1186/s12916-025-04143-6.
PubMed 40442671
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Loading, Through Application of Weight Vests, on Body Weight in Obese Subjects; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04697238
- Acronym / sponsor ID
- ATLAS / ATLAS
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High load (11 % of body weight vests) | Experimental | Device: Weight vestSubjects in this arm will carry heavy weight (11 percent of body weight) vests for 5 weeks. |
| Low load (1 % of body weight vests) | Placebo comparator | Device: Weight vestSubjects in this arm will carry heavy weight (1 percent of body weight) vests for 5 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent to participate in the study.
- Consent out of free will.
- 18-65 years of age.
- Obesity as defined by a BMI >30 and ≤35. Fat mass > 25 %.
- Willingness to comply with the study protocol
Key exclusion criteria (16 listed)
- Chronic disease that could interfere with the participation in the study as judged by the investigator. For example poorly regulated type 1 or 2 diabetes, severe cardiovascular disease that effect daily life, severe pulmonary disease that affects daily life or malignancy.
- Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip and knee pain.
- Regular consumption of medicine or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted:
- Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
- Reduced mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight vestAlso: Artificial weightsA vest weighing up to a maximum of 15 kg. | Device | High load (11 % of body weight vests), Low load (1 % of body weight vests) |
Primary outcome
Change in body weight at 5 weeks
Time frame: 35 days
Change in body weight (in percent of baseline body weight) between day 35 and baseline in the high load group compared with low load group.
10 secondary outcomes
Change in body weight at 15 days
Time frame: 15 days
Change in subcutaneous fat at 35 days
Time frame: 35 days
Change in visceral fat at 35 days
Time frame: 35 days
Change in liver fat at 35 days
Time frame: 35 days
Change in body composition at 35 days
Time frame: 35 days
Change in waist circumference at 35 days
Time frame: 35 days
Change in physical activity at 21 days
Time frame: 21 days
Change in energy expenditure at 28 days
Time frame: 28 days
Change in food intake at 28 days
Time frame: 28 days
Change in autonomic nervous system activity at 15 days
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 29279372Jansson JO, Palsdottir V, Hagg DA, Schele E, Dickson SL, Anesten F, Bake T, Montelius M, Bellman J, Johansson ME, Cone RD, Drucker DJ, Wu J, Aleksic B, Tornqvist AE, Sjogren K, Gustafsson JA, Windahl SH, Ohlsson C. Body weight homeostat that regulates fat mass independently of leptin in rats and mice. Proc Natl Acad Sci U S A. 2018 Jan 9;115(2):427-432. doi: 10.1073/pnas.1715687114. Epub 2017 Dec 26.
- Background: PubMed 32510046Ohlsson C, Gidestrand E, Bellman J, Larsson C, Palsdottir V, Hagg D, Jansson PA, Jansson JO. Increased weight loading reduces body weight and body fat in obese subjects - A proof of concept randomized clinical trial. EClinicalMedicine. 2020 Apr 30;22:100338. doi: 10.1016/j.eclinm.2020.100338. eCollection 2020 May.
- Derived from this study: PubMed 40442671Bellman J, Westerterp K, Wouters L, Johannesson M, Lundqvist N, Kullberg J, Larsson C, Gustafsson M, Pettersson S, Fridolfsson J, Arvidsson D, Borjesson M, Curiac D, Jansson JO, Jansson PA, Ohlsson C. Increased weight-load improves body composition by reducing fat mass and waist circumference, and by increasing lean mass in participants with obesity: a single-centre randomised controlled trial. BMC Med. 2025 May 30;23(1):317. doi: 10.1186/s12916-025-04143-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Curiac principal investigator
Clinical Trial Center, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight vest in people with Obesity, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight at 5 weeks (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04697238, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.