Effect of Different Weight Vests on Body Weight in Obese Individuals

NCT03672903 | Completed Phase 1 DMC

• 1 other identifier: EVO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; weight vest; gravitostat; appetite; obesity treatment; leptin; body weight; weight loss; diet-induced obesity; osteocytes; glucose metabolism

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Change in body weight between start of the intervention and end of the intervention, indirectly measuring change in BMI

  3 weeks

Secondary Outcomes (32)

• Appetite

  3 weeks

• Physical Activity

  3 weeks

• Metabolism

  3 weeks

• Metabolism

  3 weeks

• Metabolism

  3 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects in this arm will carry heavy weight vests for three weeks.

Device: Weight Vest

Control

PLACEBO COMPARATOR

Subjects in this arm will carry light weight vests for three weeks.

Device: Weight Vest

Interventions

Weight Vest DEVICE

A vest with added weights up to a maximum of 15 kg.

Also known as: artificial weights

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obesity as defined by a BMI \>30 and ≤35. Fat mass should be above 25 %.
• years of age. We will primarily recruit men. Women will only be recruited if we are unable to find 80 eligible male participants.
• Consent out of free will.
• 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.
• 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.
• Signed informed consent.

You may not qualify if:

• Chronic disease that hardens the participation in the study as judged by the investigator.
• Chronic pain such as pain that is constant and impairs quality of life; for example: severe 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-antagonists, GLP-1-agonists, SGLT2-inhibitors, sulfonylureas, insulin, orlistat, mysimba and bisphosphonates.
• Gastric by-pass surgery or equivalent.
• Reduced mobility.
• 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.
• 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.
• Drastic change in lifestyle during the last 3 months; for example a significant change in physical activity or nicotine, alcohol or drug use.
• Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-405 30, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29279372 BACKGROUND

MeSH Terms

Conditions

Obesity; Body Weight; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Per-Ander Jansson, MD, PhD, Professor

  Clinical Trial Center, Sahlgrenska University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: September 27, 2018
• Primary Completion: February 8, 2019
• Study Completion: September 6, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)