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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03170973
Other study ID # 12345
Secondary ID
Status Recruiting
Phase N/A
First received May 25, 2017
Last updated May 30, 2017
Start date May 2017
Est. completion date September 2017

Study information

Verified date April 2017
Source Faculdade Adventista da Bahia
Contact Ana Marice Prof Teixeira Ladeia, Doctor
Phone (55) 71 99964 2420
Email analadeia@uol.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date September 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- women

- Body mass index (BMI) over 24.9kg / m2

- 18-30 years

- Sedentary

Exclusion Criteria:

- cardiovascular disease,

- metabolic disease (diabetes, dyslipidemias)

- history of alcoholism or smoking,

- use of lipid-lowering agents,

- use of corticosteroids,

- uses of diuretics,

- use of beta-blockers,

- use of contraceptives,

- use of hypothyroidism,

- use of parenchymal renal diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
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.

Locations

Country Name City State
Brazil Djeyne Silveira Wagmacker Cachoeira Bahia

Sponsors (2)

Lead Sponsor Collaborator
Faculdade Adventista da Bahia Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

Barrès 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. — View Citation

Bradley 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/a — View Citation

Chen 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. — View Citation

Garelnabi 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. — View Citation

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. Epub 2007 May 3. — View Citation

Jabbour 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 20 — View Citation

Jabbour 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. Epub 2015 Oct 20. — View Citation

Jayewardene 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 20 — View Citation

Magkos 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. Epub 2005 Oct 11. — View Citation

Miyamoto 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 Spectrometr — View Citation

Plaisance 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. — View Citation

Santos 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, Quintão E, Nakandakare ER, Fonseca FA, Pim — View Citation

Thackray 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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 days
Secondary 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 3 months
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