Dietary Intervention and Assessment of Obesity-related Gene Methylation Levels in Overweight Women
Effect of Intervention With Dietary Folate and Hazelnut Oil on the Methylation Levels of the LEP and POMC Genes, Body Weight and Lipid Profile of Overweight Women
1 other identifier
interventional
40
1 country
1
Brief Summary
The clinical study aimed to study the effect of an intervention with foods containing folate and hazelnut oil to assess whether this diet could modulate the methylation levels of two obesity-related genes, LEP and POMC, in addition to impacting body weight and values of lipid profile of overweight women. The hypothesis of the clinical study is that the intervention diet could reduce the methylation levels of the genes mentioned and this would impact on the reduction of body weight and improvement of the lipid profile of the women studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started May 2015
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedDecember 9, 2020
August 1, 2020
10 months
August 19, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DNA methylation levels
For analysis of methylation levels the blood of the participants was collected, chosen for analysis, as it is a metabolically active tissue, with an important role in the adverse inflammatory and vascular consequences of adiposity, being widely used for the purpose of clinical diagnosis
week 8
Secondary Outcomes (1)
Food intake
week 8
Other Outcomes (2)
Folate food intake
week 8
Oleic Acid food intake
week 8
Study Arms (4)
Group 1: Folate + hazelnut oil
EXPERIMENTALGroup 1 = in this group, the individuals received, during the period of 08 weeks daily, daily dietary intervention with, 300 g of vegetables rich in folate - 191µg and additionally received 01 capsule containing 25 mg hazelnut oil per day.
Group 2: Folate
PLACEBO COMPARATORGroup 2 = in this group, the individuals received, during the period of 08 weeks daily, daily dietary intervention with, 300 g of folate-rich vegetables - 191 µg and 01 placebo capsule.
Group 3: Moderate folate + hazelnut oil
EXPERIMENTALGroup 3 = in this group, individuals received, during the period of 08 weeks daily, with 300 g of vegetables containing 94 µg of folate and 01 capsule containing 25 mg of hazelnut oil per day.
Group 4: Control
NO INTERVENTIONGroup 4 = in this group, individuals received weekly visits during the 08 week period to maintain their eating habits.
Interventions
Intervention with folate-rich diet and hazelnut oil supplement in capsule
Eligibility Criteria
You may qualify if:
- Adult women, aged between 20 and 59 years;
- Women with classification of overweight and obesity;
- Women who signed the informed consent form.
You may not qualify if:
- Women who changed their lifestyle 3 months before the study started;
- Alcoholic women or smokers;
- Taking medications known to interfere with folic acid metabolism (in the past 3 months), such as antacids and anticonvulsants;
- Individuals who use supplements in general, such as fish oil or other fatty acids;
- Pregnant or planning to become pregnant during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raquel Patrícia Ataíde Lima
João Pessoa, Paraíba, Brazil
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: 29046732RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raquel Lima
Federal University of Paraíba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 21, 2020
Study Start
May 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
December 9, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 30 days after publication
- Access Criteria
- Online access to researchers
Sociodemographic data, food consumption, anthropometric assessment, biochemical tests and DNA methylation of the participants. And all the statistical data that support the study.