Influence of Genetic and Physiological in Weight Loss

NCT ID: NCT03568773

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-10
• Study Completion Date: 2018-11-15

Brief Summary

The study focuses on the influence of polymorphism in the FTO genes rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by HIIT and continuous aerobic programs in obese or overweight individuals.

Detailed Description

Although the positive effects of continuous aerobic training are already well documented in the literature on health aspects. The weight loss induced by physical training is still very discrete when compared to other antiobesity means. Studies demonstrate an important variability in responses to physical exercise, indicating that individuals respond more or less to weight loss. Among these aspects, the factors that may influence exercise-induced weight loss have not yet been elucidated. Thus, the objective of the study is to analyze the influence of polymorphism in the genes FTO rs9939609 and PPARᵧ Pro12Ala, oxidative stress and systemic inflammation on changes in body composition and rest metabolism induced by continuous and continuous aerobic programs. Healthy individuals with overweight and / or obesity, aged 20-45 years, were randomly assigned to three groups: Continuous Aerobic (AC), Intermittent High Intensity Training (HIIT) and Control Group (CG). Groups (AC) and (HIIT) engaged in a 12-week program. Before the start of the program, at the sixth week and 48 hours after the intervention, they performed blood collections, ergospirometry, dual X-ray densitometry (DEXA), nutritional assessments. In addition, collection of buccal mucosa was performed for genotyping of polymorphisms studied. Initial differences between the groups, as well as between the dependent variables studied will be assessed using the two-way ANOVA test or its non-parametric equivalent. Correlation and regression tests will be performed to verify the influence of the independent variables and the magnitude of the exercise-induced weight loss, according to the normality of the data or differences between the standard deviations. The hypothesis tested is that genetic and physiological factors influence the weight loss independent of the training modality.

Conditions

Overweight and Obesity; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-intensity interval training

The HIIT protocol is being performed with the cycling mode. The program consists of repeated intense explosions alternating with recovery intervals.

The adaptation period consists of 4 shots of 20 seconds interspersed by 180 seconds interval (active recovery). From the first to the fourth week the volunteers performed from four to six race shots from 30 to 45s with intervals from 180s to 120s. From the fifth week until the end of the intervention, training takes place with six shots of 60s with a 120s interval between running shots. The work intensity for all sessions is above 95% of VO2max, with 30W of recovery. In addition, participants refer to number 19 on the Borg Scale. Sessions range from 12 to 36 minutes without heating and recovery. In total there are 12 weeks of training.

Group Type: EXPERIMENTAL

High-intensity interval training

Intervention Type: OTHER

HIIT training is being conducted on a three-day weekly frequency on a stationary bike. The protocol consisted of two weeks of adaptation with 12 weeks of training that alternated between sprints ranging from 30 s to 60 s (\> 95% VO2max), and active recovery ranging from 180 s to 120 s (30 W on the bicycle).

Aerobic exercise moderate intensity

The training protocol was started, with the sessions held in the open air. From the first to the fourth week, the volunteers gave sessions of 40 to 60 minutes, intensity in L1, three sessions / week. In the fifth week, the intensity was increased to the midpoint between L1 and half of L2, maintaining 60 minutes per session and frequency three times per week. From the sixth week, the weekly frequency increased to five days, with three supervised sessions and two unsupervised sessions, but with a smartphone application that recorded distance traveled and intensity. From the ninth week on, the weekly frequency was maintained and the intensity increased for L2. In supervised sessions, training intensity is also monitored by heart rate using a Polar heart rate monitor.

Group Type: EXPERIMENTAL

Aerobic exercise moderate intensity

Intervention Type: OTHER

The aerobic training is performed in a walking or running mode, with three weeks of adaptation (2x / wk - 20 to 30 minutes / session, \<threshold 1) and 12 weeks of training (3 to 5x / wk - 40 to 60 minutes / session, with prescribed intensities between the anaerobic threshold - L1 and the respiratory compensation point - L2).

Control Group

The control group attends stretching classes once a week and sessions lasting 60 minutes. At the end of the fifteen weeks (three weeks of adaptation and twelve weeks of training) of the study, these volunteers will be invited to engage in the aerobic training program regardless of their participation in the research.

Group Type: EXPERIMENTAL

Control Group

Intervention Type: OTHER

The control group is participating in lengthening classes to increase the adherence and control of the influencing variables. Classes are being held once a week for 60 minutes.

Interventions

High-intensity interval training

HIIT training is being conducted on a three-day weekly frequency on a stationary bike. The protocol consisted of two weeks of adaptation with 12 weeks of training that alternated between sprints ranging from 30 s to 60 s (\> 95% VO2max), and active recovery ranging from 180 s to 120 s (30 W on the bicycle).

Intervention Type: OTHER

Aerobic exercise moderate intensity

The aerobic training is performed in a walking or running mode, with three weeks of adaptation (2x / wk - 20 to 30 minutes / session, \<threshold 1) and 12 weeks of training (3 to 5x / wk - 40 to 60 minutes / session, with prescribed intensities between the anaerobic threshold - L1 and the respiratory compensation point - L2).

Intervention Type: OTHER

Control Group

The control group is participating in lengthening classes to increase the adherence and control of the influencing variables. Classes are being held once a week for 60 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Men and women aged 20-45 years;

Were insufficiently active for at least six months prior to recruitment as determined by the International Physical Activity Questionnaire (IPAQ) (<150 minutes of moderate to intense physical activity / week) (MATSUDO, 2001);

Were overweight or obese (BMI between 25kg / m2 and 39.9kg / m2) (WHO, 2015);

Did not suffer any change in weight (more than 5kg in the last three months);

Do not be smokers or acololistas (maximum of 2 doses / day);

They may not be users of supplements and / or medications that influence weight loss or weight gain;

No history of coronary, respiratory, metabolic, or musculoskeletal disease affecting ability to participate in the training program;

Have been considered fit in an exercise test performed immediately prior to physical intervention;

Women are not menopausal (menstrual cycle stopped more than one year) or have symptoms related to the climacteric phase.

Exclusion Criteria

Individuals who lack at least 25% of the total training program or two consecutive weeks;

Initiate medication treatment, supplementation, diet and / or other physical training program during the intervention period;

During training, osseous and / or myoarticular lesions that affect the ability to continue participating in the intervention.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Raquel Suelen Brito da Silva

Master/ Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FUP

Identifier Type: -

Identifier Source: org_study_id