External Body Weight Effects on Body Weight in Adults With Grade II and III Obesity

NCT06619028 | Not Yet Recruiting

• 1 other identifier: G0001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a growing problem in industrialized societies. This condition is associated with an increase in metabolic and cardiovascular diseases. Its cause is multifactorial, influenced by the environment, excessive calorie consumption, insufficient physical activity, sedentary lifestyle and alterations in energy metabolism. In this context, the hormone leptin, responsible for regulating appetite and body weight, presents resistance in people with obesity, altering the metabolic balance. Recent research has explored the concept of the "gravitostat", a system that responds to the mechanical stimulus of standing upright, as a promising approach in the regulation of body weight. Animal and human studies have shown positive results in weight loss and body recomposition using this system. However, more research is needed to evaluate the clinical applicability and effectiveness of the gravitostat in the management of obesity. For this reason, the present study is proposed, with a prospective longitudinal controlled design in the use of external body weight (where the patients are their own control: intrasubject controlled study) during 4 weeks, with a previous control period of 4 weeks and a follow-up of 4 weeks. The proposed objectives are to analyze the effectiveness of the use of external weight in the regulation of body weight, body composition and analytical parameters in people with grade II and III obesity. In this way, to analyze the clinical applicability of the gravitostat in the management of patients with this metabolic pathology.

Conditions

Obesity Prevention; Obesity

Keywords

Obesity; Body Weight; Weight loss; Treatment; Leptin; Gravitostat

Outcome Measures

Primary Outcomes (1)

• Body weight

  Measured fasting weight by electronic scale (BC-545N Tanita)

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (11)

• Nutritional state

  From enrollment to the end of treatment at 12 weeks

• Grip Strength

  From enrollment to the end of treatment at 12 weeks

• Lower Extremity Strength

  From enrollment to the end of treatment at 12 weeks

• Activity state

  From enrollment to the end of treatment at 12 weeks

• Absolute frequency of patients reporting adverse effects

  From week 4 to the end of treatment at 12 weeks

Study Arms (1)

Intervention Group (IG)

EXPERIMENTAL

During the intervention period, the participants will be exposed to an external load, by means of a weighted vest of 10% of their body weight, for a minimum of 8 hours per day for 4 weeks. In the first phase of the study, participants will be followed without changes in their lifestyle as a control. During the intervention they will be instructed to perform their usual activities with the vest, without further alterations in their lifestyle. This will be followed by a 4-week follow-up period without the use of the weighted vest.

Device: Weighted vest

Interventions

Weighted vest DEVICE

During the intervention period, the participants will be exposed to an external load, by means of a weighted vest of 10% of their body weight, for a minimum of 8 hours per day for 4 weeks. In the first phase of the study, participants will be followed without changes in their lifestyle as a control. During the intervention they will be instructed to perform their usual activities with the vest, without further alterations in their lifestyle. This will be followed by a 4-week follow-up period without the use of the weighted vest.

Also known as: External load

Intervention Group (IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• BMI (≥35)
• Compliance at intervention delivery.

You may not qualify if:

• Chronic pathology that may hinder the performance of the intervention
• Chronic pain
• Regular consumption of pharmacology or supplementation that affects body weight
• Inability to perform any physical activity or high risk of suffering adverse effects from the interventibariatric-metabolic surgery
• Reduced mobility
• Changes of 5kg or more in the last 3 months
• Drastic changes in lifestyle habits in the last 3 months (physical activity, eating habits, nicotine or alcohol consumption)
• Apparent risk of not being able to complete the study intervention (at the principal investigator\'s discretion)
• Pregnancy

Sponsors & Collaborators

• Escoles Universitaries Gimbernat: lead
• Corporacion Parc Tauli: collaborator

Study Sites (1)

EUGimbernat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

Related Publications (9)

• Palsdottir V, Windahl SH, Hagg DA, Keantar H, Bellman J, Buchanan A, Vaughan TJ, Linden D, Jansson JO, Ohlsson C. Interactions Between the Gravitostat and the Fibroblast Growth Factor System for the Regulation of Body Weight. Endocrinology. 2019 May 1;160(5):1057-1064. doi: 10.1210/en.2018-01002.

  PMID: 30888399 RESULT

• Bake T, Peris-Sampedro F, Waczek Z, Ohlsson C, Palsdottir V, Jansson JO, Dickson SL. The gravitostat protects diet-induced obese rats against fat accumulation and weight gain. J Neuroendocrinol. 2021 Aug;33(8):e12997. doi: 10.1111/jne.12997. Epub 2021 Jul 9.

  PMID: 34240761 RESULT

• Jansson JO, Dalmau Gasull A, Schele E, Dickson SL, Palsdottir V, Palmquist A, Girones FF, Bellman J, Anesten F, Hagg D, Ohlsson C. A Body Weight Sensor Regulates Prepubertal Growth via the Somatotropic Axis in Male Rats. Endocrinology. 2021 Jun 1;162(6):bqab053. doi: 10.1210/endocr/bqab053.

  PMID: 33693673 RESULT

• 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 RESULT

• Ohlsson C, Hagg DA, Hammarhjelm F, Dalmau Gasull A, Bellman J, Windahl SH, Palsdottir V, Jansson JO. The Gravitostat Regulates Fat Mass in Obese Male Mice While Leptin Regulates Fat Mass in Lean Male Mice. Endocrinology. 2018 Jul 1;159(7):2676-2682. doi: 10.1210/en.2018-00307.

  PMID: 29800288 RESULT

• 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 RESULT

• Ekblom O, Ekblom-Bak E, Rosengren A, Hallsten M, Bergstrom G, Borjesson M. Cardiorespiratory Fitness, Sedentary Behaviour and Physical Activity Are Independently Associated with the Metabolic Syndrome, Results from the SCAPIS Pilot Study. PLoS One. 2015 Jun 29;10(6):e0131586. doi: 10.1371/journal.pone.0131586. eCollection 2015.

  PMID: 26120842 RESULT

• Gallardo-Alfaro L, Bibiloni MDM, Mascaro CM, Montemayor S, Ruiz-Canela M, Salas-Salvado J, Corella D, Fito M, Romaguera D, Vioque J, Alonso-Gomez AM, Warnberg J, Martinez JA, Serra-Majem L, Estruch R, Fernandez-Garcia JC, Lapetra J, Pinto X, Garcia Rios A, Bueno-Cavanillas A, Gaforio JJ, Matia-Martin P, Daimiel L, Mico-Perez RM, Vidal J, Vazquez C, Ros E, Fernandez-Lazaro CI, Becerra-Tomas N, Gimenez-Alba IM, Zomeno MD, Konieczna J, Compan-Gabucio L, Tojal-Sierra L, Perez-Lopez J, Zulet MA, Casanas-Quintana T, Castro-Barquero S, Gomez-Perez AM, Santos-Lozano JM, Galera A, Basterra-Gortari FJ, Basora J, Saiz C, Perez-Vega KA, Galmes-Panades AM, Tercero-Macia C, Sorto-Sanchez C, Sayon-Orea C, Garcia-Gavilan J, Munoz-Martinez J, Tur JA. Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality are Associated with Metabolic Syndrome Severity: The PREDIMED-Plus Study. Nutrients. 2020 Apr 7;12(4):1013. doi: 10.3390/nu12041013.

  PMID: 32272653 RESULT

• Berthoud HR, Morrison CD, Munzberg H. The obesity epidemic in the face of homeostatic body weight regulation: What went wrong and how can it be fixed? Physiol Behav. 2020 Aug 1;222:112959. doi: 10.1016/j.physbeh.2020.112959. Epub 2020 May 16.

  PMID: 32422162 RESULT

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

• Maria Assumpta Caixàs Pedragós, PhD, MD

  Consorci Sanitari Parc Taulí

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Garcia-San-Emeterio, PhD Student

CONTACT

Spain: +34689608040; manuel.garcias@eug.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective longitudinal controlled design on the use of external body weight (where patients are their own control: intrasubject controlled study) for 4 weeks, with a 4-week pre-control period and a 4-week follow-up.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

ES (1)