ObesityNCT03170973
Influence of Exercise on Trans Fatty Acids
A study testing Exercise in people with Obesity and Motor Activity, run by Faculdade Adventista da Bahia at 1 site in Brazil.
Trial summary
Introduction: The metabolism of fatty acids in plasma is modulated by their availability in plasma. Individuals with increased weight have increased plasma fatty acids and physical exercise seems to favor the metabolic responses of fatty acid mobilization. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Motor Activity, Fatty Acids
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- May 2017to Sep 2017
- Phase
- Interventional
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- Body mass index (BMI) over 24.9kg / m2
- 18-30 years
- Sedentary
Who cannot join
- cardiovascular disease,
- metabolic disease (diabetes, dyslipidemias)
- history of alcoholism or smoking,
- use of lipid-lowering agents,
- use of corticosteroids,
- uses of diuretics,
Show all 10Show fewer
- use of beta-blockers,
- use of contraceptives,
- use of hypothyroidism,
- use of parenchymal renal diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Djeyne Silveira Wagmacker
Cachoeira, Estado de Bahia, 44300---
Djeyne Prof Silveira Wagmacker, Msc, (55) 75 99216 8222, djeyne@hotmail.com
About this study
Official title: Influences of Physical Activity in the Profile of Trans Fatty Acids in the Serum of Individuals With Body Weight Changes
Introduction: The metabolism of fatty acids in plasma is modulated by their availability in plasma. Individuals with increased weight have increased plasma fatty acids and physical exercise seems to favor the metabolic responses of fatty acid mobilization. Objective: To test the hypothesis that the physical exercise of acute way changes the fatty acids of medium chain of the serum of individuals with increase of the corporal weight. Method: Including 66 women, randomly divided into two groups, control and experiment, overweight, sedentary, and between 18 and 30 years of age. After a 12-hour fast, basal blood collection will be performed. The experiment group, 12 hours after the first collection, will be submitted to a physical exercise session with energy expenditure of 250Kcal. The volunteers in the control and experiment group will make a second blood collection 24 hours after the first one. The fatty acids will be dosed: pelargonic, azelaic, elaidic and oleic by gas chromatography. Intra and intergroup comparisons will be made using the t test for independent and dependent samples, p <0.05.
Read the detailed description
Randomized clinical trial with accessible population from the School Clinic of the Adventist Faculty of Bahia, Brazil.
All women enrolled in the Clinical School physiotherapy service with a body mass index (BMI) above 24.9kg / m2 will be invited to participate in the study. Sixty-six volunteers who met the inclusion criteria were: age between 18 and 30 years, BMI> 24.9 kg / m2 and sedentarism included randomly. Women who present cardiovascular disease, metabolic disease, history of alcoholism or smoking, use of lipid-lowering drugs, corticoids, diuretics, beta-blockers, contraceptives, hypothyroidism, parenchymal renal diseases or diabetes mellitus will be excluded.
The women will be divided randomly into two groups, experiment and control, both with 33 volunteers.
Group Exercise After a 12-hour fast, the volunteers will be submitted to a blood collection in the antecubital vein to measure basal serum triglycerides, total and fractioned cholesterol, glycemia and insulin. From the values of Glycemia and insulin the values of the Homa-IR and Homa-Beta index were calculated by the equation proposed by Matthews et al.
After 12 days after the first blood collection, the patients will perform a physical exercise session on a treadmill. The same will be divided in 3 times: heating, conditioning and cooling. The heating will be of 7 minutes, the cooling of 5 minutes and the conditioning time will be the one corresponding to the energy expenditure of 250Kcal with light intensity based on the perception of Borg effort, that is, in the original scale a value between 9 and 11. For A better understanding of this scale will be done prior to the day of the exercise accustoming the volunteers to respond adequately when asked about the intensity of the exercise.
After the physical exercise session they will be instructed to return home and maintain their usual diet. After 24 hours after the first blood collection the volunteers will return to the laboratory after a 12-hour fast and will have blood samples collected again. The diet of the two days before the blood test will be evaluated through the 24-hour food recall.
Group control The women in the control group will be submitted to the same data collection protocol of the experimental group, but will not perform exercise 12h after the first collection and will be instructed not to perform physical exercise in the two days prior to blood collection.
- Conditions
- Obesity, Motor Activity, Fatty Acids, Lipid
- Being tested
- Exercise
- Keywords
- Obesity, Motor Activity, Fatty acids, Lipid
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
After a 12-hour fast, volunteers will collect blood in the antecubital vein to measure basal serum values. 12 after the first blood collection they will perform a physical exercise session on a treadmill. The same will be divided in 3 times: heating, conditioning and cooling. The heating will be of 7 minutes, the cooling of 5 minutes and the time of conditioning will correspond to the energy expenditure of 250Kcal with light intensity based on Borg's perception of effort, that is, in the original scale a value between 9 and 11. After 24 hours after the first blood collection the volunteers will return to the laboratory after a 12-hour fast and blood samples will be collected again.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of fatty acids before and after exercise | Experimental | Not described Receives: Other: Exercise |
| Comparison of fatty acids at baseline and 24 hours after | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of fatty acids in individuals with changes in body weight before in the control and experimental group
After blood collection, the initial step for analysis of fatty acids will be the transesterification of the samples through two steps: extraction and hydrolysis / esterification. Similarly, the 99% purity standards of the fatty acids (Pelargonium, azelaic, Oleic and elaidic will also be transesterified. After the transesterification of the standards and samples, they will be analyzed by gas chromatography.
Measured: 30 days
Secondary outcomes (1)
Plasma levels of clinical variables (lipid profile, glycemic profile, oxidative and inflammatory stress) before and after physical activity.
The following data will be analyzed for total lipid profile (total cholesterol, fractions, triglycerides, TG / HDL), inflammatory (Homa-IR, Homa-Beta, Insulin, Glycemia), oxidative stress (glutathione, ON) before And after physical activity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startMay 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Will be included 66 women, randomly divided into two groups, control and experiment, overweight, sedentary and aged 18-30 years. After a 12-hour fast, baseline blood collection will be performed in both groups. The experiment group, 12 hours after the first collection, will be submitted to a physical exercise session with energy expenditure of 250Kcal. The volunteers in the control and experiment group will make a second blood collection 24 hours after the first one.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade Adventista da Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Ana Marice Prof Teixeira Ladeia, Doctor, Study director, Bahian School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170973
- Sponsor's protocol ID
- 12345
- Status last verified
- Apr 2017
- First submitted
- 25 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be available in an individual way, only with general data about the population without any form of identification of the subjects
Publications
Holloway GP, Lally J, Nickerson JG, Alkhateeb H, Snook LA, Heigenhauser GJ, Calles-Escandon J, Glatz JF, Luiken JJ, Spriet LL, Bonen A. Fatty acid binding protein facilitates sarcolemmal fatty acid transport but not mitochondrial oxidation in rat and human skeletal muscle. J Physiol. 2007 Jul 1;582(Pt 1):393-405. doi: 10.1113/jphysiol.2007.135301. Epub 2007 May 3.
PubMed 17478525Jayewardene AF, Mavros Y, Reeves A, Hancock DP, Gwinn T, Rooney KB. Interactions Between Fatty Acid Transport Proteins, Genes That Encode for Them, and Exercise: A Systematic Review. J Cell Physiol. 2016 Aug;231(8):1671-87. doi: 10.1002/jcp.25281. Epub 2016 Feb 2.
PubMed 26638980Bradley NS, Snook LA, Jain SS, Heigenhauser GJ, Bonen A, Spriet LL. Acute endurance exercise increases plasma membrane fatty acid transport proteins in rat and human skeletal muscle. Am J Physiol Endocrinol Metab. 2012 Jan 15;302(2):E183-9. doi: 10.1152/ajpendo.00254.2011. Epub 2011 Oct 25.
PubMed 22028411Barres R, Yan J, Egan B, Treebak JT, Rasmussen M, Fritz T, Caidahl K, Krook A, O'Gorman DJ, Zierath JR. Acute exercise remodels promoter methylation in human skeletal muscle. Cell Metab. 2012 Mar 7;15(3):405-11. doi: 10.1016/j.cmet.2012.01.001.
PubMed 22405075Jabbour G, Iancu HD, Paulin A, Lavoie JM, Lemoine-Morel S, Zouhal H. Effects of Acute Supramaximal Cycle Exercise on Plasma FFA Concentration in Obese Adolescent Boys. PLoS One. 2015 Jun 15;10(6):e0129654. doi: 10.1371/journal.pone.0129654. eCollection 2015.
PubMed 26076464Jabbour G, Iancu HD, Paulin A. Effects of High-Intensity Training on Anaerobic and Aerobic Contributions to Total Energy Release During Repeated Supramaximal Exercise in Obese Adults. Sports Med Open. 2015;1(1):36. doi: 10.1186/s40798-015-0035-7. Epub 2015 Oct 20.
PubMed 26512339Plaisance EP, Mestek ML, Mahurin AJ, Taylor JK, Moncada-Jimenez J, Grandjean PW. Postprandial triglyceride responses to aerobic exercise and extended-release niacin. Am J Clin Nutr. 2008 Jul;88(1):30-7. doi: 10.1093/ajcn/88.1.30.
PubMed 18614721Chen MJ, Fan X, Moe ST. Criterion-related validity of the Borg ratings of perceived exertion scale in healthy individuals: a meta-analysis. J Sports Sci. 2002 Nov;20(11):873-99. doi: 10.1080/026404102320761787.
PubMed 12430990Santos RD, Gagliardi AC, Xavier HT, Magnoni CD, Cassani R, Lottenberg AM; Sociedade Brasileira de Cardiologia; Arpadi Faludi A, Geloneze B, Scherr C, Kovacs C, Tomazzela C, Carla C, Barrera-Arellano D, Cintra D, Quintao E, Nakandakare ER, Fonseca FA, Pimentel I, Ernesto dos Santos J, Bertolami MC, Rogero M, Izar MC, Nakasato M, Teixeira Damasceno NR, Maranhao R, Cassani RS, Perim R, Ramos S; Sociedade Brasileira de Cardiologia. [First guidelines on fat consumption and cardiovascular health]. Arq Bras Cardiol. 2013 Jan;100(1 Suppl 3):1-40. No abstract available. Portuguese.
PubMed 23598539Garelnabi M, Litvinov D, Parthasarathy S. Evaluation of a gas chromatography method for azelaic acid determination in selected biological samples. N Am J Med Sci. 2010 Sep;2(9):397-402. doi: 10.4297/najms.2010.2397.
PubMed 22558586Miyamoto S, Taylor SL, Barupal DK, Taguchi A, Wohlgemuth G, Wikoff WR, Yoneda KY, Gandara DR, Hanash SM, Kim K, Fiehn O. Systemic Metabolomic Changes in Blood Samples of Lung Cancer Patients Identified by Gas Chromatography Time-of-Flight Mass Spectrometry. Metabolites. 2015 Apr 9;5(2):192-210. doi: 10.3390/metabo5020192.
PubMed 25859693Magkos F, Wright DC, Patterson BW, Mohammed BS, Mittendorfer B. Lipid metabolism response to a single, prolonged bout of endurance exercise in healthy young men. Am J Physiol Endocrinol Metab. 2006 Feb;290(2):E355-62. doi: 10.1152/ajpendo.00259.2005. Epub 2005 Oct 11.
PubMed 16219668Thackray AE, Barrett LA, Tolfrey K. High-Intensity Running and Energy Restriction Reduce Postprandial Lipemia in Girls. Med Sci Sports Exerc. 2016 Mar;48(3):402-11. doi: 10.1249/MSS.0000000000000788.
PubMed 26460628Wagmacker DS, Petto J, Fraga AS, Matias JB, Mota SKA, Rodrigues LEA, Ladeia AM. Metabolic Reponses to a physical exercise session in women with excess body mass: randomized clinical trial. Lipids Health Dis. 2017 Dec 19;16(1):249. doi: 10.1186/s12944-017-0600-9.
PubMed 29258520
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Physical Activity in the Profile of Trans Fatty Acids in the Serum of Individuals With Body Weight Changes
- ClinicalTrials.gov ID
- NCT03170973
- Acronym / sponsor ID
- 12345
- Conditions
- Obesity, Motor Activity, Fatty Acids, Lipid
- Keywords
- Obesity, Motor Activity, Fatty acids, Lipid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Faculdade Adventista da BahiaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- May 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 31 May 2017 (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.
Introduction: The metabolism of fatty acids in plasma is modulated by their availability in plasma. Individuals with increased weight have increased plasma fatty acids and physical exercise seems to favor the metabolic responses of fatty acid mobilization. Objective: To test the hypothesis that the physical exercise of acute way changes the fatty acids of medium chain of the serum of individuals with increase of the corporal weight. Method: Including 66 women, randomly divided into two groups, control and experiment, overweight, sedentary, and between 18 and 30 years of age. After a 12-hour fast, basal blood collection will be performed. The experiment group, 12 hours after the first collection, will be submitted to a physical exercise session with energy expenditure of 250Kcal. The volunteers in the control and experiment group will make a second blood collection 24 hours after the first one. The fatty acids will be dosed: pelargonic, azelaic, elaidic and oleic by gas chromatography. Intra and intergroup comparisons will be made using the t test for independent and dependent samples, p <0.05.
Detailed description
Randomized clinical trial with accessible population from the School Clinic of the Adventist Faculty of Bahia, Brazil.
All women enrolled in the Clinical School physiotherapy service with a body mass index (BMI) above 24.9kg / m2 will be invited to participate in the study. Sixty-six volunteers who met the inclusion criteria were: age between 18 and 30 years, BMI> 24.9 kg / m2 and sedentarism included randomly. Women who present cardiovascular disease, metabolic disease, history of alcoholism or smoking, use of lipid-lowering drugs, corticoids, diuretics, beta-blockers, contraceptives, hypothyroidism, parenchymal renal diseases or diabetes mellitus will be excluded.
The women will be divided randomly into two groups, experiment and control, both with 33 volunteers.
Group Exercise After a 12-hour fast, the volunteers will be submitted to a blood collection in the antecubital vein to measure basal serum triglycerides, total and fractioned cholesterol, glycemia and insulin. From the values of Glycemia and insulin the values of the Homa-IR and Homa-Beta index were calculated by the equation proposed by Matthews et al.
After 12 days after the first blood collection, the patients will perform a physical exercise session on a treadmill. The same will be divided in 3 times: heating, conditioning and cooling. The heating will be of 7 minutes, the cooling of 5 minutes and the conditioning time will be the one corresponding to the energy expenditure of 250Kcal with light intensity based on the perception of Borg effort, that is, in the original scale a value between 9 and 11. For A better understanding of this scale will be done prior to the day of the exercise accustoming the volunteers to respond adequately when asked about the intensity of the exercise.
After the physical exercise session they will be instructed to return home and maintain their usual diet. After 24 hours after the first blood collection the volunteers will return to the laboratory after a 12-hour fast and will have blood samples collected again. The diet of the two days before the blood test will be evaluated through the 24-hour food recall.
Group control The women in the control group will be submitted to the same data collection protocol of the experimental group, but will not perform exercise 12h after the first collection and will be instructed not to perform physical exercise in the two days prior to blood collection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Will be included 66 women, randomly divided into two groups, control and experiment, overweight, sedentary and aged 18-30 years. After a 12-hour fast, baseline blood collection will be performed in both groups. The experiment group, 12 hours after the first collection, will be submitted to a physical exercise session with energy expenditure of 250Kcal. The volunteers in the control and experiment group will make a second blood collection 24 hours after the first one.
| Arm | Type | Receives |
|---|---|---|
| Comparison of fatty acids before and after exercise | Experimental | Other: Exercise |
| Comparison of fatty acids at baseline and 24 hours after | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women
- Body mass index (BMI) over 24.9kg / m2
- 18-30 years
- Sedentary
Key exclusion criteria (10 listed)
- cardiovascular disease,
- metabolic disease (diabetes, dyslipidemias)
- history of alcoholism or smoking,
- use of lipid-lowering agents,
- use of corticosteroids,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAfter a 12-hour fast, volunteers will collect blood in the antecubital vein to measure basal serum values. 12 after the first blood collection they will perform a physical exercise session on a treadmill. The same will be divided in 3 times: heating, conditioning and cooling. The heating will be of 7 minutes, the cooling of 5 minutes and the time of conditioning will correspond to the energy expenditure of 250Kcal with light intensity based on Borg's perception of effort, that is, in the original scale a value between 9 and 11. After 24 hours after the first blood collection the volunteers will return to the laboratory after a 12-hour fast and blood samples will be collected again. | Other | Comparison of fatty acids before and after exercise |
Primary outcome
Levels of fatty acids in individuals with changes in body weight before in the control and experimental group
Time frame: 30 days
After blood collection, the initial step for analysis of fatty acids will be the transesterification of the samples through two steps: extraction and hydrolysis / esterification. Similarly, the 99% purity standards of the fatty acids (Pelargonium, azelaic, Oleic and elaidic will also be transesterified. After the transesterification of the standards and samples, they will be analyzed by gas chromatography.
1 secondary outcome
Plasma levels of clinical variables (lipid profile, glycemic profile, oxidative and inflammatory stress) before and after physical activity.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 17478525Holloway GP, Lally J, Nickerson JG, Alkhateeb H, Snook LA, Heigenhauser GJ, Calles-Escandon J, Glatz JF, Luiken JJ, Spriet LL, Bonen A. Fatty acid binding protein facilitates sarcolemmal fatty acid transport but not mitochondrial oxidation in rat and human skeletal muscle. J Physiol. 2007 Jul 1;582(Pt 1):393-405. doi: 10.1113/jphysiol.2007.135301. Epub 2007 May 3.
- Results publication: PubMed 26638980Jayewardene AF, Mavros Y, Reeves A, Hancock DP, Gwinn T, Rooney KB. Interactions Between Fatty Acid Transport Proteins, Genes That Encode for Them, and Exercise: A Systematic Review. J Cell Physiol. 2016 Aug;231(8):1671-87. doi: 10.1002/jcp.25281. Epub 2016 Feb 2.
- Results publication: PubMed 22028411Bradley NS, Snook LA, Jain SS, Heigenhauser GJ, Bonen A, Spriet LL. Acute endurance exercise increases plasma membrane fatty acid transport proteins in rat and human skeletal muscle. Am J Physiol Endocrinol Metab. 2012 Jan 15;302(2):E183-9. doi: 10.1152/ajpendo.00254.2011. Epub 2011 Oct 25.
- Results publication: PubMed 22405075Barres R, Yan J, Egan B, Treebak JT, Rasmussen M, Fritz T, Caidahl K, Krook A, O'Gorman DJ, Zierath JR. Acute exercise remodels promoter methylation in human skeletal muscle. Cell Metab. 2012 Mar 7;15(3):405-11. doi: 10.1016/j.cmet.2012.01.001.
- Results publication: PubMed 26076464Jabbour G, Iancu HD, Paulin A, Lavoie JM, Lemoine-Morel S, Zouhal H. Effects of Acute Supramaximal Cycle Exercise on Plasma FFA Concentration in Obese Adolescent Boys. PLoS One. 2015 Jun 15;10(6):e0129654. doi: 10.1371/journal.pone.0129654. eCollection 2015.
- Results publication: PubMed 26512339Jabbour G, Iancu HD, Paulin A. Effects of High-Intensity Training on Anaerobic and Aerobic Contributions to Total Energy Release During Repeated Supramaximal Exercise in Obese Adults. Sports Med Open. 2015;1(1):36. doi: 10.1186/s40798-015-0035-7. Epub 2015 Oct 20.
- Results publication: PubMed 18614721Plaisance EP, Mestek ML, Mahurin AJ, Taylor JK, Moncada-Jimenez J, Grandjean PW. Postprandial triglyceride responses to aerobic exercise and extended-release niacin. Am J Clin Nutr. 2008 Jul;88(1):30-7. doi: 10.1093/ajcn/88.1.30.
- Results publication: PubMed 12430990Chen MJ, Fan X, Moe ST. Criterion-related validity of the Borg ratings of perceived exertion scale in healthy individuals: a meta-analysis. J Sports Sci. 2002 Nov;20(11):873-99. doi: 10.1080/026404102320761787.
- Results publication: PubMed 23598539Santos RD, Gagliardi AC, Xavier HT, Magnoni CD, Cassani R, Lottenberg AM; Sociedade Brasileira de Cardiologia; Arpadi Faludi A, Geloneze B, Scherr C, Kovacs C, Tomazzela C, Carla C, Barrera-Arellano D, Cintra D, Quintao E, Nakandakare ER, Fonseca FA, Pimentel I, Ernesto dos Santos J, Bertolami MC, Rogero M, Izar MC, Nakasato M, Teixeira Damasceno NR, Maranhao R, Cassani RS, Perim R, Ramos S; Sociedade Brasileira de Cardiologia. [First guidelines on fat consumption and cardiovascular health]. Arq Bras Cardiol. 2013 Jan;100(1 Suppl 3):1-40. No abstract available. Portuguese.
- Results publication: PubMed 22558586Garelnabi M, Litvinov D, Parthasarathy S. Evaluation of a gas chromatography method for azelaic acid determination in selected biological samples. N Am J Med Sci. 2010 Sep;2(9):397-402. doi: 10.4297/najms.2010.2397.
- Results publication: PubMed 25859693Miyamoto S, Taylor SL, Barupal DK, Taguchi A, Wohlgemuth G, Wikoff WR, Yoneda KY, Gandara DR, Hanash SM, Kim K, Fiehn O. Systemic Metabolomic Changes in Blood Samples of Lung Cancer Patients Identified by Gas Chromatography Time-of-Flight Mass Spectrometry. Metabolites. 2015 Apr 9;5(2):192-210. doi: 10.3390/metabo5020192.
- Results publication: PubMed 16219668Magkos F, Wright DC, Patterson BW, Mohammed BS, Mittendorfer B. Lipid metabolism response to a single, prolonged bout of endurance exercise in healthy young men. Am J Physiol Endocrinol Metab. 2006 Feb;290(2):E355-62. doi: 10.1152/ajpendo.00259.2005. Epub 2005 Oct 11.
- Individual participant dataSharing planned: No. The data will not be available in an individual way, only with general data about the population without any form of identification of the subjects
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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.
Ana Marice Prof Teixeira Ladeia, Doctor study director
Bahian School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity and Motor Activity, run by Faculdade Adventista da Bahia at 1 site in Brazil.
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 4 inclusion and 10 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 31 May 2017. 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 Brazil. 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 Ana Marice Prof Teixeira Ladeia, Doctor ((55) 71 99964 2420, analadeia@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of fatty acids in individuals with changes in body weight before in the control and experimental group (time frame: 30 days). 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 NCT03170973, which also lists 14 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 31 May 2017.