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Dietary Intervention and Assessment of Obesity-related Gene Methylation Levels in Overweight Women

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary folate and hazelnut oil
Sponsored by
Thamires Ribeiro Chaves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Epigenetic, Obesity, Diet, Folate, Monounsaturated fat

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult women, aged between 20 and 59 years;
  • Women with classification of overweight and obesity;
  • Women who signed the informed consent form.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Raquel Patrícia Ataíde Lima

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

No Intervention

Arm Label

Group 1: Folate + hazelnut oil

Group 2: Folate

Group 3: Moderate folate + hazelnut oil

Group 4: Control

Arm Description

Group 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 = 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 = 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 = in this group, individuals received weekly visits during the 08 week period to maintain their eating habits.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Food intake
It is a method that describes a wide variety of foods, Reminder 24h (R24h) is used when you want to compare the average nutrient intake of different populations.

Full Information

First Posted
August 19, 2020
Last Updated
December 7, 2020
Sponsor
Thamires Ribeiro Chaves
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1. Study Identification

Unique Protocol Identification Number
NCT04523532
Brief Title
Dietary Intervention and Assessment of Obesity-related Gene Methylation Levels in Overweight Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thamires Ribeiro Chaves

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The intervention study was carried out with a sample selected by randomization, and n = 40 adult women classified as overweight were considered for the study. After assessing the eligibility criteria, women were instructed to have stable weight, eating habits and levels of physical activity constant to those found during the baseline, as well as receiving an individual diet plan one week before starting the dietary intervention. Before the start of the intervention, the 40 women were allocated to four groups of 10 each, and three groups started the individual diet plan for weight maintenance with a focus on vegetables and legumes with antioxidant and folate-rich action, and were also invited to consume foods fortified with folic acid and foods naturally rich in folate to achieve a usual folate intake close to the RAS (≥400 µg), this amount was for intervention group 1 and 2, group 3 received a lower amount (approximately half of the consumption of groups 1 and 2) and group 4 was the control group. Still referring to the intervention, the participants of the three groups received advice from a nutritionist, responsible for this research and all the printed material free of charge, including pre-packaged foods, and also delivered hazelnut oil capsules, used as a source of monounsaturated fat. Counseling sessions with the nutritionist were offered daily at the homes during the entire period of the intervention, except for group 4, where the monitoring was weekly, to maintain eating habits. After the end of the 8 weeks of the intervention, the third stage of the study began, which consisted of anthropometric assessment, analysis of the dietary intake of the 24-hour food record and blood collection for biochemical tests and DNA methylation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Epigenetic, Obesity, Diet, Folate, Monounsaturated fat

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Folate + hazelnut oil
Arm Type
Experimental
Arm Description
Group 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.
Arm Title
Group 2: Folate
Arm Type
Placebo Comparator
Arm Description
Group 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.
Arm Title
Group 3: Moderate folate + hazelnut oil
Arm Type
Experimental
Arm Description
Group 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.
Arm Title
Group 4: Control
Arm Type
No Intervention
Arm Description
Group 4 = in this group, individuals received weekly visits during the 08 week period to maintain their eating habits.
Intervention Type
Other
Intervention Name(s)
Dietary folate and hazelnut oil
Intervention Description
Intervention with folate-rich diet and hazelnut oil supplement in capsule
Primary Outcome Measure Information:
Title
DNA methylation levels
Description
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
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Food intake
Description
It is a method that describes a wide variety of foods, Reminder 24h (R24h) is used when you want to compare the average nutrient intake of different populations.
Time Frame
week 8
Other Pre-specified Outcome Measures:
Title
Folate food intake
Description
Three 24-hour reminders were used to assess folate intake, subsequently analyzed in food software and to estimate habitual consumption and correct intrapersonal variance, the online multi-source method (MSM), available on the website, (https: // msm .dife.de / tps / msm /). MSM is a statistical technique proposed by the European Prospective Investigation into cancer and Nutrition.
Time Frame
week 8
Title
Oleic Acid food intake
Description
Three 24-hour reminders were used to assess oleic acid intake, subsequently analyzed in food software and to estimate habitual consumption and correct intrapersonal variance, the online multi-source method (MSM), available on the website, (https: // msm .dife.de / tps / msm /). MSM is a statistical technique proposed by the European Prospective Investigation into cancer and Nutrition.
Time Frame
week 8

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult women, aged between 20 and 59 years; Women with classification of overweight and obesity; Women who signed the informed consent form. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Lima
Organizational Affiliation
Federal University of Paraíba
Official's Role
Study Director
Facility Information:
Facility Name
Raquel Patrícia Ataíde Lima
City
João Pessoa
State/Province
Paraíba
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sociodemographic data, food consumption, anthropometric assessment, biochemical tests and DNA methylation of the participants. And all the statistical data that support the study.
IPD Sharing Time Frame
30 days after publication
IPD Sharing Access Criteria
Online access to researchers
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
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://clinicalepigeneticsjournal.biomedcentral.com/articles/10.1186/s13148-017-0407-6

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Dietary Intervention and Assessment of Obesity-related Gene Methylation Levels in Overweight Women

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