Sedentary BehaviorATANCT05758311
The Project ATA: Adipose Tissue & Adipokines
An observational study of Sedentary Behavior and Overweight, run by Dynamical Business and Science Society - DBSS International SAS at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Overweight, Obesity
- How many people
- 378 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adipose Tissue & Adipokines (ATA): From Laboratory to Clinical Practice - The Project ATA
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.
Read the detailed description
Obesity is a multifactorial disease characterized by excess and accumulation of body fat, which implies hypertrophy and hyperplasia of adipocytes (i.e. adipose tissue cells). However, obesity is not only related to lipid accumulation in adipose tissue but could also generate morpho-functional changes in other tissues. The deleterious effects of lipid accumulation in non-adipose tissues are known as lipotoxicity. Lipotoxicity generates certain metabolic alterations, which affect overall metabolic health, leading to ectopic fat accumulation (i.e. fat accumulation outside its proper place). These factors can result in an increased likelihood of chronic diseases, including cardiovascular disease, type 2 diabetes mellitus, non-alcoholic fatty liver disease, chronic kidney disease, and different types of cancer. There is substantial variation between individuals, some obese people may remain metabolically healthy and some lean people may have metabolic diseases. Additionally, adipose tissue in addition to having an energy storage role produces hormones that regulate different physiological processes, such as inflammatory responses, mechanical cushioning and insulation, and participation in heat production for body temperature regulation. These processes can change adaptively (or maladaptation) during the loss or gain of body mass. Importantly, insufficient adipose tissue (lipodystrophy) or adipose tissue dysfunction (e.g. obesity) leads to excessive lipid deposition in other organs such as the liver and muscle.
Obesity comprises much damage in different tissues of the organism; however, these changes are potentially reversible by taking advantage of the innate property of biological systems to favor adaptation to repeated stimuli (e.g., changes in habits and lifestyles). The particularity of obesity is the expansion of adipose tissue, although this does not always mean that it is pathological. A clear example is natural obesity in various mammals during the pre-hibernation stage and subsequent periods of high physical activity. Healthy adipose tissue expansion is accompanied by adequate capillary angiogenesis and mitochondria-centered metabolic control. On the other hand, unhealthy adipose tissue expansion is associated with capillary and mitochondrial impairment, resulting in immune cell deposition and excessive production of proinflammatory cytokines. In addition, some pathologies of metabolically healthy obese individuals have well-preserved adipose tissue function, associated with fewer comorbidities and lower mortality rates compared to lean individuals.
The reasons for studying beyond the energetic function of adipose tissue are based on the plasticity of adipose tissue and its different types (both morphological and metabolic). Traditionally, adipose tissue is classified as white adipose tissue (WAT), brown adipose tissue (BAT), and beige adipose tissue (bAT). However, other types of adipose tissue have been identified, including pink and yellow (bone marrow) adipose tissue, highlighting their physiological functions after trans-differentiation processes. It is necessary to establish an understanding of the complexity of adipose tissue and its endocrine interaction with other tissues to determine the physiological response to external stimuli (e.g., overenergetic diet, physical inactivity, sedentary lifestyle, cancer, etc.). In fact, a geographical variation of obesity and the associated risk factors has been reported by different research groups. This questions and highlights the need to improve the obesity metrics for diagnosis and monitoring.
The aim of 'Project ATA' is double: i) to profile the population with excess fat mass (overweight and obesity) using body composition data and the concentration of adipomyokines, and ii) to evaluate the association between morphophysiological and endocrine variables in order to propose practical geographical-based recommendations to assess and monitor obesity accurately.
- Conditions
- Sedentary Behavior, Overweight, Obesity
- Keywords
- Body Composition, Body Fat Distribution, Biomarkers, Cardiovascular Risk, Anthropometry, Bioelectrical Impedance, Adipomyokines
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: July 2023 to August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SAS
- Sponsor type
- Research network
- Collaborators
- CES University, Universidad de Córdoba
- Responsible party
- Sponsor
- Investigators
- Diego A Bonilla, MSc, Principal investigator, Research Division, Dynamical Business & Science Society - DBSS International SAS, Bogotá, ColombiaLuis M Gómez-Miranda, PhD, Principal investigator, Sports School, Autonomous University of Baja California, Tijuana 22390, MéxicoDaniel Rojas-Valverde, PhD, Principal investigator, Núcleo de Estudios para el Alto Rendimiento y la Salud (CIDISAD-NARS), Heredia, Costa RicaSalvador Vargas-Molina, MSc, Principal investigator, Faculty of Sport Sciences, EADE-University of Wales Trinity Saint David, 29018 Málaga, SpainKatherine Franco-Hoyos, MSc, Principal investigator, Nutral, Universidad CES, Medellín, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758311
- Sponsor's protocol ID
- ATA_DBSS
- Acronym
- ATA
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study will be used for research purposes, according to the bioethical standards established by the Institutional Review Board (IRB) and the procedures will be developed in accordance with the latest version of the Declaration of Helsinki. Investigators will not share the identity of those who participate in the research. The information investigators collect in this research project will be kept confidential, will be kept off-limits, and no one except the researchers will have access to it. Any information about the participant will have an identifying number (rather than the name) at the time of analysis. Only the researchers will know what the number is and the information will be kept confidential. It will not be shared or given to anyone except participants, a Data and Safety Monitoring Board (DSMB), or others participants authorize (e.g., physician, nutritionist).
Publications
Apovian CM. Obesity: definition, comorbidities, causes, and burden. Am J Manag Care. 2016 Jun;22(7 Suppl):s176-85.
PubMed 27356115Bonilla 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.
PubMed 33792415Bremner 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.
PubMed 32823562
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue & Adipokines (ATA): From Laboratory to Clinical Practice - The Project ATA
- ClinicalTrials.gov ID
- NCT05758311
- Acronym / sponsor ID
- ATA / ATA_DBSS
- Conditions
- Sedentary Behavior, Overweight, Obesity
- Keywords
- Body Composition, Body Fat Distribution, Biomarkers, Cardiovascular Risk, Anthropometry, Bioelectrical Impedance, Adipomyokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SASResearch network
- Collaborators
- CES University, Universidad de Córdoba
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a multifactorial disease characterized by excess and accumulation of body fat, which implies hypertrophy and hyperplasia of adipocytes (i.e. adipose tissue cells). However, obesity is not only related to lipid accumulation in adipose tissue but could also generate morpho-functional changes in other tissues. The deleterious effects of lipid accumulation in non-adipose tissues are known as lipotoxicity. Lipotoxicity generates certain metabolic alterations, which affect overall metabolic health, leading to ectopic fat accumulation (i.e. fat accumulation outside its proper place). These factors can result in an increased likelihood of chronic diseases, including cardiovascular disease, type 2 diabetes mellitus, non-alcoholic fatty liver disease, chronic kidney disease, and different types of cancer. There is substantial variation between individuals, some obese people may remain metabolically healthy and some lean people may have metabolic diseases. Additionally, adipose tissue in addition to having an energy storage role produces hormones that regulate different physiological processes, such as inflammatory responses, mechanical cushioning and insulation, and participation in heat production for body temperature regulation. These processes can change adaptively (or maladaptation) during the loss or gain of body mass. Importantly, insufficient adipose tissue (lipodystrophy) or adipose tissue dysfunction (e.g. obesity) leads to excessive lipid deposition in other organs such as the liver and muscle.
Obesity comprises much damage in different tissues of the organism; however, these changes are potentially reversible by taking advantage of the innate property of biological systems to favor adaptation to repeated stimuli (e.g., changes in habits and lifestyles). The particularity of obesity is the expansion of adipose tissue, although this does not always mean that it is pathological. A clear example is natural obesity in various mammals during the pre-hibernation stage and subsequent periods of high physical activity. Healthy adipose tissue expansion is accompanied by adequate capillary angiogenesis and mitochondria-centered metabolic control. On the other hand, unhealthy adipose tissue expansion is associated with capillary and mitochondrial impairment, resulting in immune cell deposition and excessive production of proinflammatory cytokines. In addition, some pathologies of metabolically healthy obese individuals have well-preserved adipose tissue function, associated with fewer comorbidities and lower mortality rates compared to lean individuals.
The reasons for studying beyond the energetic function of adipose tissue are based on the plasticity of adipose tissue and its different types (both morphological and metabolic). Traditionally, adipose tissue is classified as white adipose tissue (WAT), brown adipose tissue (BAT), and beige adipose tissue (bAT). However, other types of adipose tissue have been identified, including pink and yellow (bone marrow) adipose tissue, highlighting their physiological functions after trans-differentiation processes. It is necessary to establish an understanding of the complexity of adipose tissue and its endocrine interaction with other tissues to determine the physiological response to external stimuli (e.g., overenergetic diet, physical inactivity, sedentary lifestyle, cancer, etc.). In fact, a geographical variation of obesity and the associated risk factors has been reported by different research groups. This questions and highlights the need to improve the obesity metrics for diagnosis and monitoring.
The aim of 'Project ATA' is double: i) to profile the population with excess fat mass (overweight and obesity) using body composition data and the concentration of adipomyokines, and ii) to evaluate the association between morphophysiological and endocrine variables in order to propose practical geographical-based recommendations to assess and monitor obesity accurately.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anthropometric Assessment
Time frame: July 2023 to August 2024
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.
Anthropometry-Based Analysis of Body Composition
Time frame: July 2023 to August 2024
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).
Bioelectrical Impedance Analysis
Time frame: July 2023 to August 2024
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.
Adipokines and blood screening
Time frame: July 2023 to August 2024
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 27356115Apovian CM. Obesity: definition, comorbidities, causes, and burden. Am J Manag Care. 2016 Jun;22(7 Suppl):s176-85.
- Background: PubMed 33792415Bonilla 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.
- Background: PubMed 32823562Bremner 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.
- Individual participant dataSharing planned: No. The data collected in this study will be used for research purposes, according to the bioethical standards established by the Institutional Review Board (IRB) and the procedures will be developed in accordance with the latest version of the Declaration of Helsinki. Investigators will not share the identity of those who participate in the research. The information investigators collect in this research project will be kept confidential, will be kept off-limits, and no one except the researchers will have access to it. Any information about the participant will have an identifying number (rather than the name) at the time of analysis. Only the researchers will know what the number is and the information will be kept confidential. It will not be shared or given to anyone except participants, a Data and Safety Monitoring Board (DSMB), or others participants authorize (e.g., physician, nutritionist).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego A Bonilla, MSc principal investigator
Research Division, Dynamical Business & Science Society - DBSS International SAS, Bogotá, Colombia
Luis M Gómez-Miranda, PhD principal investigator
Sports School, Autonomous University of Baja California, Tijuana 22390, México
Daniel Rojas-Valverde, PhD principal investigator
Núcleo de Estudios para el Alto Rendimiento y la Salud (CIDISAD-NARS), Heredia, Costa Rica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Behavior and Overweight, run by Dynamical Business and Science Society - DBSS International SAS at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego A Bonilla, MSc ((57)3203352050, dabonilla@dbss.pro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric Assessment (time frame: July 2023 to August 2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758311, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.