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Profile Of Methylation and Gene Expression Of Gene ADRB3 And Effects Of Folate Intake

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Folate and capsule of oil hazel
Folate and placebo
antioxidant and placebo
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals adults, aged 20 and 59 years;
  • Being female;
  • Individuals who have hypermethylation in ADRB3 gene;
  • cognitive state preserved.

Exclusion Criteria:

  • Individuals drinkers or smokers;

    • Take medications known to interfere with the metabolism of folic acid (the last 3 months);
    • Individuals who make use of fish oil supplement or other fatty acids;
    • Pregnant or planning to become pregnant during the study period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Folate

    placebo

    diet antioxidant

    Hazelnut Oil

    Arm Description

    diet rich in folate

    placebo

    diet antioxidant

    hazelnut oil capsule

    Outcomes

    Primary Outcome Measures

    Change in value of the weight (kg)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 15, 2016
    Last Updated
    July 29, 2016
    Sponsor
    Federal University of Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02846025
    Brief Title
    Profile Of Methylation and Gene Expression Of Gene ADRB3 And Effects Of Folate Intake
    Official Title
    Profile Of Methylation and Gene Expression Of Gene ADRB3 And Effects Of Ingestion Of Folate, Hazelnuts And Diets Oil Capsule Antioxidants In Case Inflammatory
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Paraíba

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    ABSTRACT Epigenetic mechanisms may be involved in the regulation of lipid metabolism and inflammatory markers may therefore contribute to the cardiovascular risk profile, as well as environmental factors have a significant impact on the epigenetic program of gene expression. Methyl groups are usually added or removed as needed and can be influenced by diet soon, dietary factors have been linked to the change of DNA methylation, resulting in changes in gene expression. Research on the prevalence of gene methylation levels on the impact of nutrient intake, as well as the inflammatory condition and the results of dietary interventions for the genes, it is a sparse area in studies and, therefore, expanding of the knowledge. Thus, understanding the effects of a diet rich in antioxidants and hazelnut oil, in inflammation and DNA methylation profile is important because chronic diseases with cardiovascular disease can begin with the consumption of modified lipids and can research this stage provide important dietary allowances for the development of this disease prevention strategies even in adulthood. This PhD project is linked to a larger project entitled "II Diagnosis Cycle and Intervention Food Situation, Nutrition and Noncommunicable Diseases Prevalent over the City Population of João Pessoa / PB" (II DISANDNT / PB) and have two methodological designs: the first one is the composition of a representative sample of adults in the city of João Pessoa, from II DISANDNT / JP, population-based study and cross-sectional. The second methodological design was developed with a subsample of the above population, selected from criteria being the type and interventional clinical trial. This model will have to evaluate the effect of a diet rich in antioxidant and hazelnut oil, in inflammation and gene expression.
    Detailed Description
    This thesis is linked to a population-based survey entitled "Diagnosis II Cycle and Intervention Food Situation, Nutrition and Noncommunicable Diseases Prevalent over the city of João Pessoa Population / PB" (II DISANDNT / PB). For realization of this thesis, a first population-based study, representative of adults in the east areas and west of the city of João Pessoa, there was the calculation of a representative sample for the age group of adults, using information provided by the city, as map the municipality, the number of blocks per district and the Brazilian Institute of Geography and Statistics. Home visits and implementation of the survey questionnaires were carried out by teams of undergraduate researchers from the Nutrition courses, masters and doctoral students of the Post Graduate Program in Nutrition Sciences (PPGCN) UFPB duly previously trained at the beginning of data collection after the pilot study and following. The trained teams, after recognizing the drawn court, were instructed to select all households in the court. The blocks that did not have homes, the homes in which those responsible have not accepted to participate and the amount of individuals who refused to participate in randomly selected households were computed and resorteadas randomly thereafter to minimize losses. In each residence drawn all individuals, adults aged between 20-59 years were invited to participate in the research through application of socioeconomic and demographic characteristics questionnaires, epidemiological characterization, nutritional assessment and food intake, biochemical evaluation and brands epigenetic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Folate
    Arm Type
    Other
    Arm Description
    diet rich in folate
    Arm Title
    placebo
    Arm Type
    Other
    Arm Description
    placebo
    Arm Title
    diet antioxidant
    Arm Type
    Other
    Arm Description
    diet antioxidant
    Arm Title
    Hazelnut Oil
    Arm Type
    Other
    Arm Description
    hazelnut oil capsule
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Folate and capsule of oil hazel
    Intervention Description
    rich diet aministracao folate and capsule of oil hazel
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Folate and placebo
    Intervention Description
    rich diet aministracao folate and placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    antioxidant and placebo
    Intervention Description
    antioxidant diet (90μg folate) and placebo capsule
    Primary Outcome Measure Information:
    Title
    Change in value of the weight (kg)
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals adults, aged 20 and 59 years; Being female; Individuals who have hypermethylation in ADRB3 gene; cognitive state preserved. Exclusion Criteria: Individuals drinkers or smokers; Take medications known to interfere with the metabolism of folic acid (the last 3 months); Individuals who make use of fish oil supplement or other fatty acids; Pregnant or planning to become pregnant during the study period.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria José Carvalho Costa, Doctor
    Organizational Affiliation
    UFPB
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data of the participants are in the excel database
    Citations:
    PubMed Identifier
    29046732
    Citation
    Lima RPA, do Nascimento RAF, Luna RCP, Persuhn DC, da Silva AS, da Conceicao Rodrigues Goncalves M, de Almeida ATC, de Moraes RM, Junior EV, Fouilloux-Meugnier E, Vidal H, Pirola L, Magnani M, de Oliveira NFP, Prada PO, de Carvalho Costa MJ. Effect of a diet containing folate and hazelnut oil capsule on the methylation level of the ADRB3 gene, lipid profile and oxidative stress in overweight or obese women. Clin Epigenetics. 2017 Oct 13;9:110. doi: 10.1186/s13148-017-0407-6. eCollection 2017.
    Results Reference
    derived

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