Anti-obesity Treatment by Loading in Adult Subjects

NCT04697238 | Completed DMC

• 1 other identifier: ATLAS
• Study Type: interventional
• Target: 59
• 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  35 days

Secondary Outcomes (10)

• Change in body weight at 15 days

  15 days

• Change in subcutaneous fat at 35 days

  35 days

• Change in visceral fat at 35 days

  35 days

• Change in liver fat at 35 days

  35 days

• Change in body composition at 35 days

  35 days

Study Arms (2)

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.

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.

Device: Weight vest

Interventions

Weight vest DEVICE

A vest weighing up to a maximum of 15 kg.

Also known as: Artificial weights

High load (11 % of body weight vests); Low load (1 % of body weight vests)

Eligibility Criteria

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

You may qualify if:

• Signed informed consent to participate in the study.
• Consent out of free will.
• 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:
• 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:
• i. Normal: Values within the reference interval supplied by the local lab at Sahlgrenska University Hospital
• ii. 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.

You may not qualify if:

• 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.
• 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.
• a. Excessive amounts of above-mentioned substances defined as:
• i. 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.
• ii. 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Clinical Trial Center, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 405 30, Sweden

Location

Related Publications (3)

• 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

• Ohlsson 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.

  PMID: 32510046 BACKGROUND

• Bellman 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.

  PMID: 40442671 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dan Curiac

  Clinical Trial Center, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects might be able to determine if they are in the control group or intervention group since it is difficult to mask the difference between a heavy and a light weight vest. Therefore, intervention in this study won't be masked for the participants. However, group affiliation will be masked for outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 6, 2021
• Study Start: September 1, 2021
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: March 17, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)