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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04523532
Other study ID # TChaves
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date March 2016

Study information

Verified date August 2020
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 59 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Raquel Patrícia Ataíde Lima João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Thamires Ribeiro Chaves

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Lima RPA, do Nascimento RAF, Luna RCP, Persuhn DC, da Silva AS, da Conceição Rodrigues Gonçalves 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 d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Folate food intake 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. week 8
Other Oleic Acid food intake 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. week 8
Primary 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 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. week 8
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