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

About this trial
This is an interventional prevention trial for Overweight and Obesity
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.
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
NCT ID
NCT02846025
First Posted
July 15, 2016
Last Updated
July 29, 2016
Sponsor
Federal University of Paraíba
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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Profile Of Methylation and Gene Expression Of Gene ADRB3 And Effects Of Folate Intake
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