ObesityNCT02922491
Effect of Vitamin E Supplementation in Methylation and microRNAs Profile
A study testing vitamin E and starch in people with Obesity, run by Federal University of Paraíba at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- vitamin E and starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2016to 10 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects;
- Persons aged between 20 and 59 years;
- Overweight or obese;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT
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.
- Conditions
- Obesity
- Being tested
- vitamin E, starch
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin EDietary supplement
daily intake of vitamin E
starchDietary supplement
daily intake of starch (control)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 400 mg Vitamin E of synthetic source
1 once daily during 2 months Receives: Dietary Supplement: vitamin E |
| Group 2 | Experimental | 400 mg Vitamin E of natural source
1 once daily during 2 months Receives: Dietary Supplement: vitamin E |
| Group control | Placebo comparator | 400 mg of starch
1 once daily during 2 months Receives: Dietary Supplement: starch |
| No intervention | No intervention | Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E
Measured: two months
Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Nov 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafaella Cristhine Pordeus Luna, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922491
- Sponsor's protocol ID
- FUParaíba1
- Status last verified
- Feb 2017
- First submitted
- 17 Sep 2016
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30008789
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT
- ClinicalTrials.gov ID
- NCT02922491
- Acronym / sponsor ID
- FUParaíba1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: vitamin E400 mg Vitamin E of synthetic source 1 once daily during 2 months |
| Group 2 | Experimental | Dietary Supplement: vitamin E400 mg Vitamin E of natural source 1 once daily during 2 months |
| Group control | Placebo comparator | Dietary Supplement: starch400 mg of starch 1 once daily during 2 months |
| No intervention | No intervention | –Without intervention |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female subjects;
- Persons aged between 20 and 59 years;
- Overweight or obese;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin Edaily intake of vitamin E | Dietary supplement | Group 1, Group 2 |
| starchdaily intake of starch (control) | Dietary supplement | Group control |
Primary outcome
Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E
Time frame: two months
Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Derived from this study: PubMed 30008789Luna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin E and starch in people with Obesity, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E (time frame: two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.