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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ana Marice Prof Teixeira Ladeia, Doctor
  • Phone Number: (55) 71 99964 2420
  • Email: analadeia@uol.com.br

Study Contact Backup

  • Name: Djeyne Prof Silveira Wagmacker, Msc
  • Phone Number: (55) 75 99216 8222
  • Email: djeyne@hotmail.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculdade Adventista da Bahia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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