Influence of Exercise on Trans Fatty Acids

May 30, 2017 updated by: Faculdade Adventista da Bahia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Cachoeira, Bahia, Brazil, 44300---
        • Recruiting
        • Djeyne Silveira Wagmacker
        • Contact:
          • Djeyne Prof Silveira Wagmacker, Msc
          • Phone Number: (55) 75 99216 8222
          • Email: djeyne@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade Adventista da Bahia

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Director: Ana Marice Prof Teixeira Ladeia, Doctor, Bahian School of Medicine and Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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