Influence of Exercise on Trans Fatty Acids
Primary Purpose
Obesity, Motor Activity, Fatty Acids
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, Motor Activity, Fatty acids, Lipid
Eligibility 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
Sites / Locations
- Djeyne Silveira WagmackerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Comparison of fatty acids before and after exercise
Comparison of fatty acids at baseline and 24 hours after
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03170973
First Posted
May 25, 2017
Last Updated
May 30, 2017
Sponsor
Faculdade Adventista da Bahia
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03170973
Brief Title
Influence of Exercise on Trans Fatty Acids
Official Title
Influences of Physical Activity in the Profile of Trans Fatty Acids in the Serum of Individuals With Body Weight Changes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faculdade Adventista da Bahia
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Motor Activity, Fatty Acids, Lipid
Keywords
Obesity, Motor Activity, Fatty acids, Lipid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparison of fatty acids before and after exercise
Arm Type
Experimental
Arm Title
Comparison of fatty acids at baseline and 24 hours after
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Levels of fatty acids in individuals with changes in body weight before in the control and experimental group
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Plasma levels of clinical variables (lipid profile, glycemic profile, oxidative and inflammatory stress) before and after physical activity.
Description
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
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Marice Prof Teixeira Ladeia, Doctor
Phone
(55) 71 99964 2420
Email
analadeia@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Djeyne Prof Silveira wagmacker, MsC
Phone
(55) 75 99216 8222
Email
djeyne@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Marice Prof Teixeira Ladeia, Doctor
Organizational Affiliation
Bahian School of Medicine and Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Djeyne Silveira Wagmacker
City
Cachoeira
State/Province
Bahia
ZIP/Postal Code
44300---
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djeyne Prof Silveira Wagmacker, Msc
Phone
(55) 75 99216 8222
Email
djeyne@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Citations:
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Influence of Exercise on Trans Fatty Acids
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