The Project ATA: Adipose Tissue & Adipokines

NCT05758311 | Unknown

• 1 other identifier: ATA_DBSS
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

It is essential to delve deeper into the molecular and tissue aspects that allow us to recognize the roles of adipose tissue and its interaction with the musculoskeletal (i.e., adipomyokines) to facilitate the identification of biomarkers that can complement the assessment of body composition. Thus, investigators posed the following research question: what characteristics of adipose tissue can investigators consider to rethink assessment for the diagnosis and treatment of obesity? The 'Project ATA' is a cross-sectional study based on the Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut) guidelines, an Extension of the STROBE Statement. The FINER strategy (Feasible, Interesting, Novel, Ethical, and Relevant) and previously published guidelines for organizing a multicenter study will be followed. The 'Project ATA' will test the associations of several morphological metrics and adipomyokines in order to both profile populations with excess body fat and to establish practical geographical-based recommendations for practitioners.

Conditions

Sedentary Behavior; Overweight; Obesity

Keywords

Body Composition; Body Fat Distribution; Biomarkers; Cardiovascular Risk; Anthropometry; Bioelectrical Impedance; Adipomyokines

Outcome Measures

Primary Outcomes (4)

• Anthropometric Assessment

  All measurements will be performed according to the International Standards for Anthropometric Evaluation published by the International Society for the Advancement of Kineanthropometry (ISAK) to obtain basic measurements expressed in absolute data. Means will be calculated and analyzed from two measurements of anthropometric data.

  July 2023 to August 2024

• Anthropometry-Based Analysis of Body Composition

  The whole-body fat percentage (RFM), the sum of skinfolds, the waist girth (minimal and umbilicus), the body mass to waist girth, waist girth to stature ratios. Finally, musculoskeletal index, the skinfold-corrected muscle girths for the arm, chest, waist, thigh, and calf will be calculated according to the expression: girth - (π x skinfold).

  July 2023 to August 2024

• Bioelectrical Impedance Analysis

  To evaluate adult subjects with excess adiposity by foot-to-foot bioelectrical impedance analysis (BIA). Estimated values of percent fat mass (FM), percent muscle mass (MA), metabolic age (ma), basal metabolic rate (BMR), and visceral fat (VFL). In addition, bioelectrical impedance vector analysis (BIVA) will be performed and raw variables related to phase angle and body composition will be reported.

  July 2023 to August 2024

• Adipokines and blood screening

  Will be collected peripheral blood samples, where it will be taken into account serum amyloid A, resistin, leptin, adiponectin, and visfatin concentrations will be quantified by direct chemiluminescence using acridinium ester technology.

  July 2023 to August 2024

Study Arms (1)

Multi-center study

The study population will be inhabitants of both sexes with different levels of physical activity who reside in the metropolitan area of cities in Colombia, Mexico, Costa Rica, and Spain. The population sample will be obtained through an internal call to students and administrative personnel of universities and Smart Fit sites with an inter-institutional collaboration agreement with Dynamical Business \& Science Society (DBSS International). The first study will be carried out in Colombia.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be inhabitants of both sexes with different levels of physical activity who reside in the metropolitan area of cities in Colombia, Mexico, Costa Rica, and Spain. Investigators will primarily consider university students, administrative personnel, and other potentially eligible adults of both sexes who respond to the study announcement, fulfill inclusion criteria and sign the informed consent form. To understand the prevalence or proportion of a given phenotype among adults in a city a formula based on previously reported proportions will be used to calculate the sample size.

You may qualify if:

• People over 18 years of age (under 60 years of age).
• People born and residing in major cities or neighboring municipalities of the metropolitan area of selected cities. The first stage will take place in Medellín (Colombia) and then continue in other cities in Colombia, Costa Rica, Mexico, and Spain according to logistics procedures.
• Those who sign the informed consent to undergo the measurements.

You may not qualify if:

• Those physically active people who exercise vigorously and systematically or at a competitive level.
• Those diagnosed with a musculoskeletal disease and/or special condition that limits mobility during the taking of measurements (musculoskeletal injury).
• People over 60 years of age.
• Pregnant women.
• People with implants or synthetic prostheses.

Sponsors & Collaborators

• Dynamical Business and Science Society - DBSS International SAS: lead
• CES University: collaborator
• Universidad de Córdoba: collaborator

Study Sites (1)

DBSS

Bogotá, 110311, Colombia

Location

Related Publications (3)

• Apovian CM. Obesity: definition, comorbidities, causes, and burden. Am J Manag Care. 2016 Jun;22(7 Suppl):s176-85.

  PMID: 27356115 BACKGROUND

• Bonilla DA, De Leon LG, Alexander-Cortez P, Odriozola-Martinez A, Herrera-Amante CA, Vargas-Molina S, Petro JL. Simple anthropometry-based calculations to monitor body composition in athletes: Scoping review and reference values. Nutr Health. 2022 Mar;28(1):95-109. doi: 10.1177/02601060211002941. Epub 2021 Apr 1.

  PMID: 33792415 BACKGROUND

• Bremner JD, Moazzami K, Wittbrodt MT, Nye JA, Lima BB, Gillespie CF, Rapaport MH, Pearce BD, Shah AJ, Vaccarino V. Diet, Stress and Mental Health. Nutrients. 2020 Aug 13;12(8):2428. doi: 10.3390/nu12082428.

  PMID: 32823562 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected from the forearm veins of the participants to quantify the concentration of adipokines and lipid profile.

MeSH Terms

Conditions

Sedentary Behavior; Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Diego A Bonilla, MSc

  Research Division, Dynamical Business & Science Society - DBSS International SAS, Bogotá, Colombia

  PRINCIPAL INVESTIGATOR

• Luis M Gómez-Miranda, PhD

  Sports School, Autonomous University of Baja California, Tijuana 22390, México

  PRINCIPAL INVESTIGATOR

• Daniel Rojas-Valverde, PhD

  Núcleo de Estudios para el Alto Rendimiento y la Salud (CIDISAD-NARS), Heredia, Costa Rica

  PRINCIPAL INVESTIGATOR

• Salvador Vargas-Molina, MSc

  Faculty of Sport Sciences, EADE-University of Wales Trinity Saint David, 29018 Málaga, Spain

  PRINCIPAL INVESTIGATOR

• Katherine Franco-Hoyos, MSc

  Nutral, Universidad CES, Medellín, Colombia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego A Bonilla, MSc

CONTACT

(57)3203352050; dabonilla@dbss.pro

Jorge L Petro, MSc

CONTACT

(57)3126096944; jlpetro@dbss.pro

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 7, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)