Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-62kr6f |
Date of registration:
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06/09/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of two different physical training associated with diet on health in obese
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Scientific title:
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Effects of high intensity interval training and moderate continuous associated with diet on cardiometabolic parameters in obese |
Date of first enrolment:
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12/05/2016 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-62kr6f |
Study type:
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Intervention |
Study design:
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Randomized clinical trial, paralel, open with three groups.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Ana Paula Trussardi
Fayh |
Address:
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Avenida Senador Salgado Filho, s/n, Lagoa Nova
59078-970
Natal
Brazil |
Telephone:
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+55(84)33422291 |
Email:
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apfayh@yhaoo.com.br |
Affiliation:
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Universidade Federal do Rio Grande do Norte - UFRN |
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Name:
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Ana Paula Trussardi
Fayh |
Address:
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Avenida Senador Salgado Filho, s/n, Lagoa Nova
59078-970
Natal
Brazil |
Telephone:
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+55(84)33422291 |
Email:
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apfayh@yhaoo.com.br |
Affiliation:
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Universidade Federal do Rio Grande do Norte - UFRN |
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Key inclusion & exclusion criteria
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Inclusion criteria: Volunteers should not be engaged in exercise programs; body mass index between 30 and 39,9; body mass stability in the last six months.
Exclusion criteria: Current smokers; body mass index greater than 40; have a clinical diagnosis of chronic non-communicable diseases; pregnant; postpartum; breastfeeding.
Age minimum:
20Y
Age maximum:
45Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Obesity, metabolic syndrome
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C18.654.726.500
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C18.452.394.968.500.570
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Intervention(s)
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In total, 75 patients should be randomized to one of the three experimental groups, detailed below: 1) Continuous aerobic training (n = 25); 2) High intensity interval training (n = 25); and 3) Control (n = 25). Each group will consist of 25 volunteers. It is emphasized that all volunteers should carry out a personalized diet to reduce body weight. After the preliminary evaluation of their level of physical activity and body composition, the subjects will follow the method of randomization to determine in which group they will participate in the study. At this point, it will also be reinforced that, regardless of the group in which he is participating, he should conduct periodic nutritional consultations for nutritional re-education and weight adjustment, if necessary. After these considerations, individuals will receive clarification on the examinations to be performed before, during and after the intervention. At a previously scheduled date, the subjects should attend the DEF / UFRN Laboratory in a 12-hour fast, to perform blood collection and body composition evaluation using the bioimpedance technique. After the offer of a balanced meal, the subjects will perform a resting electrocardiogram by a competent physician, followed by a physical evaluation by means of the maximum progressive load test on a cycloergometer, to determine the initial physical condition. During exercise testing, the subject will continue to be monitored by the electrocardiogram. From these results, parameters are obtained on the aerobic capacity of the volunteers, and the intensity for the training can be calculated in the case group, which will be detailed below. After all initial evaluations, the first nutritional consultation will be scheduled, with a properly trained nutritionist.
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G11.427.410.698.277.187
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Other
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E02.642.249.285
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Primary Outcome(s)
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Insulin resistance: will be assessed from the HOMA index, which takes into account biochemical measurements of glucose and insulin. A 10% reduction in the value of HOMA will be considered satisfactory.
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Secondary Outcome(s)
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Body composition: assessed by DEXA imaging. A reduction of at least 10% in your total fat mass is expected.
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Lipid profile: will be evaluated through the biochemical measurements of total cholesterol and its fractions, and triglycerides. To be considered as reached, individuals are expected to reach normal values in these parameters, ie total cholesterol <200 mg / dL, HDL cholesterol> 40 mg / dL, LDL cholesterol <160 mg / dL and triglycerides <150 mg / dL.
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Source(s) of Monetary Support
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Universidade Federal do Rio Grande do Norte - UFRN
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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