NCT02922491

Brief Summary

It is a study of clinical and interventional character, in which individuals who participate in the intervention will be selected for convenience of the project database entitled "Second Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable Disease More Prevalent Population of the city of João Pessoa / PB ". They will be invited to participate in the intervention female subjects, overweight or obese, aged 20 and 59 years. The selected individuals will be distributed randomly into four groups: receive daily supplementation of 01 capsules containing 400 mg of vitamin E synthetic source (Group 1); receive daily supplementation of 01 capsules containing 400 mg of natural source vitamin E (Group 2); receive daily supplementation of 01 placebo capsule (control group); and non-intervention group. Individuals of intervention groups will receive dietary plan respecting individual needs, in order to control weight during the 08 weeks period. The subjects of the group without intervention, did not follow a diet plan, nor did they take vitamin E or placebo capsules, and were asked to continue their current eating habits over the 8-week period This project aims to evaluate whether vitamin E supplementation may modify the methylation and microRNAs profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
Last Updated

March 23, 2018

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

September 17, 2016

Last Update Submit

March 21, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E

    two months

  • Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E

    two months

Study Arms (4)

Group 1

EXPERIMENTAL

400 mg Vitamin E of synthetic source 1 once daily during 2 months

Dietary Supplement: vitamin E

Group 2

EXPERIMENTAL

400 mg Vitamin E of natural source 1 once daily during 2 months

Dietary Supplement: vitamin E

Group control

PLACEBO COMPARATOR

400 mg of starch 1 once daily during 2 months

Dietary Supplement: starch

No intervention

NO INTERVENTION

Without intervention

Interventions

vitamin EDIETARY_SUPPLEMENT

daily intake of vitamin E

Group 1Group 2
starchDIETARY_SUPPLEMENT

daily intake of starch (control)

Group control

Eligibility Criteria

Age20 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects;
  • Persons aged between 20 and 59 years;
  • Overweight or obese;

You may not qualify if:

  • Individuals consumed alcohol and / or chronic smokers;
  • Individuals who do not have preserved cognitive status;
  • Individuals users of multivitamins and mineral supplements, appetite suppressants and steroids;
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafaella Cristhine Pordeus Luna

João Pessoa, Paraíba, 58051900, Brazil

Location

Related Publications (1)

  • Luna RCP, Dos Santos Nunes MK, Monteiro MGCA, da Silva CSO, do Nascimento RAF, Lima RPA, Pimenta FCF, de Oliveira NFP, Persuhn DC, de Almeida ATC, da Silva Diniz A, Pissetti CW, Vianna RPT, de Lima Ferreira FEL, Rodrigues Goncalves MDC, de Carvalho Costa MJ. alpha-Tocopherol influences glycaemic control and miR-9-3 DNA methylation in overweight and obese women under an energy-restricted diet: a randomized, double-blind, exploratory, controlled clinical trial. Nutr Metab (Lond). 2018 Jul 11;15:49. doi: 10.1186/s12986-018-0286-7. eCollection 2018.

    PMID: 30008789DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Vitamin EStarch

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in nutritional sciences

Study Record Dates

First Submitted

September 17, 2016

First Posted

October 4, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 10, 2016

Last Updated

March 23, 2018

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)