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Influence of Exercise on Trans Fatty Acids

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ClinicalTrials.gov Identifier: NCT03170973
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Faculdade Adventista da Bahia

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Motor Activity Fatty Acids Lipid Other: Exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Influences of Physical Activity in the Profile of Trans Fatty Acids in the Serum of Individuals With Body Weight Changes
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Comparison of fatty acids before and after exercise 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.
No Intervention: Comparison of fatty acids at baseline and 24 hours after



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Plasma levels of clinical variables (lipid profile, glycemic profile, oxidative and inflammatory stress) before and after physical activity. [ Time Frame: 3 months ]
    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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170973


Contacts
Contact: Ana Marice Prof Teixeira Ladeia, Doctor (55) 71 99964 2420 analadeia@uol.com.br
Contact: Djeyne Prof Silveira wagmacker, MsC (55) 75 99216 8222 djeyne@hotmail.com

Locations
Brazil
Djeyne Silveira Wagmacker Recruiting
Cachoeira, Bahia, Brazil, 44300---
Contact: Djeyne Prof Silveira Wagmacker, Msc    (55) 75 99216 8222    djeyne@hotmail.com   
Sponsors and Collaborators
Faculdade Adventista da Bahia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Ana Marice Prof Teixeira Ladeia, Doctor Bahian School of Medicine and Public Health

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Faculdade Adventista da Bahia
ClinicalTrials.gov Identifier: NCT03170973     History of Changes
Other Study ID Numbers: 12345
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faculdade Adventista da Bahia:
Obesity
Motor Activity
Fatty acids
Lipid