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Effect of Different Weight Vests on Body Weight in Obese Individuals (EVO)

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ClinicalTrials.gov Identifier: NCT03672903
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:

Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the Western World. The proposed research may result in improved prevention, diagnosis and treatments of obesity and obesity-related disorders. Recently published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control.

We aim to confirm these findings in a human model. We plan to let obese subjects carry weight vests and monitor their change in body weight. We will also measure appetite, physical activity and insulin sensitivity to further examine the potential beneficial effects of loading. Blood sampling will be performed to investigate the mechanism of action.


Condition or disease Intervention/treatment Phase
Obesity Device: Weight Vest Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will use a parallel study design in which we compare the placebo group with the intervention group. In order to avoid the risk of carry-over effects, we 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, we 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, we have no information about the wash-out time needed to avoid this problem.
Masking: Single (Participant)
Masking Description: Masking will not be publically revealed before the study ends. Subjects may be able to determine if they are in the control/placebo group or intervention group if we publically reveal our masking procedure. However, the masking procedure is pre-determined and approved by the ethic's committee.
Primary Purpose: Treatment
Official Title: Effect of Different Weight Vests on Body Weight in Obese Individuals
Actual Study Start Date : September 27, 2018
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Intervention
Subjects in this arm will carry heavy weight vests for three weeks.
Device: Weight Vest
A vest with added weights up to a maximum of 15 kg.
Other Name: artificial weights

Placebo Comparator: Control
Subjects in this arm will carry light weight vests for three weeks.
Device: Weight Vest
A vest with added weights up to a maximum of 15 kg.
Other Name: artificial weights




Primary Outcome Measures :
  1. Body Weight [ Time Frame: 3 weeks ]
    Change in body weight between start of the intervention and end of the intervention, indirectly measuring change in BMI


Secondary Outcome Measures :
  1. Appetite [ Time Frame: 3 weeks ]
    Calories consumed and choice of food

  2. Physical Activity [ Time Frame: 3 weeks ]
    Steps taken and walking distance

  3. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of Na

  4. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of K

  5. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of Cl

  6. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of Ca

  7. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of Creatinine

  8. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of insulin

  9. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of HDL-Cholesterol

  10. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of LDL-Cholesterol

  11. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of triacylglycerol (TAG)

  12. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of FGF21

  13. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of osteocalcin

  14. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of FGF23

  15. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of FGF15

  16. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of sclerostin

  17. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of lipocaline

  18. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of leptin

  19. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of ghrelin

  20. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of GLP-1

  21. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of GLP-2

  22. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of CCK

  23. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of (3-36)PYY

  24. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of glucagon

  25. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of testosterone

  26. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of estrogens

  27. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of renin

  28. Metabolism [ Time Frame: 3 weeks ]
    We will measure the change in serum concentration of methoxynorepinephrine

  29. Fat Mass [ Time Frame: 3 weeks ]
    Change in fat mass between start of the intervention and end of the intervention

  30. Muscle Mass [ Time Frame: 3 weeks ]
    Change in muscle mass between start of the intervention and end of the intervention

  31. Water Mass [ Time Frame: 3 weeks ]
    Change in water mass between start of the intervention and end of the intervention

  32. Bone Mass [ Time Frame: 3 weeks ]
    Change in bone mass between start of the intervention and end of the intervention



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Obesity as defined by a BMI >30 and ≤35. Fat mass should be above 25 %.
  2. 18-70 years of age. We will primarily recruit men. Women will only be recruited if we are unable to find 80 eligible male participants.
  3. Consent out of free will.
  4. Willingness to comply with the study protocol and restrictions of not consuming excessive amounts of alcohol (maximum 1 litre, 11 % or alcohol equivalent for a full week) or using any drugs. Smoking and snuff use is allowed.
  5. Normal screening blood- and urine samples. In blood: hemoglobin, white blood cells, trombocytes, sodium, potassium, creatinine, ASAT, ALAT, HbA1c, CRP, T4, TSH. In urine: nitrite, white blood cells, red blood cells, glucose, creatinine and albumin.
  6. Signed informed consent.

Exclusion Criteria:

  1. Chronic disease that hardens the participation in the study as judged by the investigator.
  2. Chronic pain such as pain that is constant and impairs quality of life; for example: severe back, hip and knee pain.
  3. 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-antagonists, GLP-1-agonists, SGLT2-inhibitors, sulfonylureas, insulin, orlistat, mysimba and bisphosphonates.
  4. Gastric by-pass surgery or equivalent.
  5. Reduced mobility.
  6. Pregnancy: Females of childbearing potential must confirm to use reliable contraception and not suspect to be pregnant. Subjects may be asked to perform a pregnancy test.
  7. 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 1.5 kg difference between day 1 and day 8 will not be accepted.
  8. Drastic change in lifestyle during the last 3 months; for example a significant change in physical activity or nicotine, alcohol or drug use.
  9. Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672903


Locations
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Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, S-405 30
Sponsors and Collaborators
Vastra Gotaland Region
Göteborg University
Investigators
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Principal Investigator: Per-Ander Jansson, MD, PhD, Professor Clinical Trial Center, Sahlgrenska University hospital

Additional Information:
Publications:
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03672903     History of Changes
Other Study ID Numbers: EVO
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vastra Gotaland Region:
obesity
weight vest
gravitostat
appetite
obesity treatment
leptin
body weight
weight loss
diet-induced obesity
osteocytes
glucose metabolism
Additional relevant MeSH terms:
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Obesity
Body Weight
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms