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

NCT02846025 | Completed Phase 2 DMC

• 1 other identifier: UFPBNUTRI
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in value of the weight (kg)

  3 months

Study Arms (4)

Folate

OTHER

diet rich in folate

Dietary Supplement: Folate and capsule of oil hazel; Dietary Supplement: Folate and placebo

placebo

OTHER

placebo

Dietary Supplement: Folate and placebo; Dietary Supplement: antioxidant and placebo

diet antioxidant

OTHER

diet antioxidant

Dietary Supplement: antioxidant and placebo

Hazelnut Oil

OTHER

hazelnut oil capsule

Dietary Supplement: Folate and capsule of oil hazel

Interventions

Folate and capsule of oil hazel DIETARY_SUPPLEMENT

rich diet aministracao folate and capsule of oil hazel

Folate; Hazelnut Oil

Folate and placebo DIETARY_SUPPLEMENT

rich diet aministracao folate and placebo

Folate; placebo

antioxidant and placebo DIETARY_SUPPLEMENT

antioxidant diet (90μg folate) and placebo capsule

diet antioxidant; placebo

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Related Publications (1)

• 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.

  PMID: 29046732 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Folic Acid; Antioxidants

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Maria José Carvalho Costa, Doctor

  UFPB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 27, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share