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

NCT ID: NCT04523532

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

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.

Conditions

Obesity

Keywords

Epigenetic; Obesity; Diet; Folate; Monounsaturated fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: Folate + hazelnut oil

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 Type: EXPERIMENTAL

Dietary folate and hazelnut oil

Intervention Type: OTHER

Intervention with folate-rich diet and hazelnut oil supplement in capsule

Group 2: Folate

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 Type: PLACEBO_COMPARATOR

Dietary folate and hazelnut oil

Intervention Type: OTHER

Intervention with folate-rich diet and hazelnut oil supplement in capsule

Group 3: Moderate folate + hazelnut oil

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 Type: EXPERIMENTAL

Dietary folate and hazelnut oil

Intervention Type: OTHER

Intervention with folate-rich diet and hazelnut oil supplement in capsule

Group 4: Control

Group 4 = in this group, individuals received weekly visits during the 08 week period to maintain their eating habits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary folate and hazelnut oil

Intervention with folate-rich diet and hazelnut oil supplement in capsule

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thamires Ribeiro Chaves

OTHER

Sponsor Role: lead

Responsible Party

Thamires Ribeiro Chaves

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Raquel Lima

Role: STUDY_DIRECTOR

Federal University of Paraíba

Locations

Raquel Patrícia Ataíde Lima

João Pessoa, Paraíba, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 29046732 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

TChaves

Identifier Type: -

Identifier Source: org_study_id