ObesityFASUPPNCT01841658
Folic Acid Supplementation in Women of Child Bearing Age
A study testing Folic acid in people with Obesity, run by University of Georgia at 1 site in United States.
Trial summary
The objective of this study is to identify genes whose expression is potentially modifiable due to changes in folate intake and help delineate mechanisms accounting for the variability in individual response to folic acid supplementation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Screening Phase:
- Female 18-40 yr
- Body Mass index 18.5 to 24.9 or > 30 kg/m2
- Intervention Study:
- Serum folate < 30 nmol/L
- MTHFR677CC or MTHFR677CT genotype
Who cannot join
- Currently pregnant, pregnancy within past 12 months
- Greater than 2 previous pregnancies
- Use of prescription drugs other than oral contraceptives
- Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
- Acute illness (pneumonia, urinary tract infection, mononucleosis)
- Use of antibiotics in past 30 days
Show all 12Show fewer
- Current smoker
- Use of dietary supplements including multivitamins in past 30 days
- Habitual consumption of fortified ready-to-eat cereals
- Significant weight change in past 12 months
- Typical alcohol consumption of 2 or more drinks per day
- INTERVENTION: all above plus serum folate > 30 nmol/L; MTHFR677TT genotype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Obesity and Folic Acid Supplementation on Gene-specific DNA Methylation in Women of Reproductive Age
The objective of this study is to identify genes whose expression is potentially modifiable due to changes in folate intake and help delineate mechanisms accounting for the variability in individual response to folic acid supplementation. The study will be conducted in normal weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic acid.
It is hypothesized that (1) a change in folate status, induced by the supplementation, will influence the DNA methylation of specific genes and (2) the DNA methylation response to folic acid supplementation may differ between the normal weight and the obese women of childbearing age.
Read the detailed description
This study will be conducted in two phases. An initial screening study will be performed to determine folate status, MTHFR677 genotype and body composition of potential participants of the intervention study. Both folate status and MTHFR677 genotype are known independent predictors of response to folic acid supplementation. Blood samples will be collected, after an overnight fast, for determination of serum folate concentration and for MTHFR677 genotyping. Body composition and 24-hr dietary recalls will also be conducted during the screening visit.
The second phase is an eight week supplementation trial with 800 mcg/day folic acid. Screened individuals determined to have a serum folate < 30 nmol/L (< 50th percentile of NHANES 1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion in the supplementation trial. Participants will be instructed to avoid dietary supplements, fortified ready-to-eat cereals, and other high folate content foods during intervention. Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8 weeks of supplementation for determination of primary (DNA methylation profile) and secondary (nutritional, metabolic and health status biomarkers) outcome measures.
- Conditions
- Obesity
- Being tested
- Folic acid
- Keywords
- Folate Status, Folate Biomarkers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDietary supplement
Participants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count.
| Study group | Role | What they receive |
|---|---|---|
| Folic Acid Normal Weight | Experimental | Folic acid, tablet, 800 mcg, daily, eight weeks. Normal Weight individuals, each will serve as her own control. Receives: Dietary Supplement: Folic acid |
| Folic acid Obese | Experimental | Folic acid, tablet, 800 mcg, daily, eight weeks. Obese individuals, each will serve as her own control. Receives: Dietary Supplement: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-type-specific DNA methylation
Change in DNA methylation in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined in DNA isolated from specific white blood cell types. Microarray analysis will be used to assess changes in multiple methylation sites within regulatory pathways for folate metabolism and/or development. Each subject will serve as her own control.
Measured: Baseline, 4 weeks and 8 weeks
Gene-specific DNA methylation
Change in DNA methylation in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined in DNA isolated from whole blood . Microarray analysis will be used to assess changes in multiple methylation sites of specific genes within regulatory pathways for folate metabolism and/or development. Each subject will serve as her own control.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (3)
Serum folate
Change in serum folate concentrations in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus. Each subject will serve as her own control.
Measured: Baseline, 4 weeks and 8 weeks
Red Blood Cell (RBC) Folate
Change in red blood cell (RBC) folate in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined by microbiological assay using Lactobacillus rhamnosus.
Measured: Baseline, 4 weeks and 8 weeks
Body Composition
Body composition in terms of fat mass (g), lean mass (g) and % body fat will be determined using the BODPOD instrument and verified by dual-energy X-ray absorptiometry (DXA). The DXA analysis will also provide an indication of regional fat distribution, and total bone area, bone mineral content and bone density.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Emory University
- Responsible party
- Principal investigator, Lynn B. Bailey, PhD, University of Georgia
- Investigators
- Lynn B Bailey, PhD, Principal investigator, University of GeorgiaDorothy Hausman, PhD, Study director, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841658
- Sponsor's protocol ID
- UGA_FASUPPLEMENT_EPIGEN
- Acronym
- FASUPP
- Status last verified
- Jul 2016
- First submitted
- 19 Apr 2013
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obesity and Folic Acid Supplementation on Gene-specific DNA Methylation in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT01841658
- Acronym / sponsor ID
- FASUPP / UGA_FASUPPLEMENT_EPIGEN
- Conditions
- Obesity
- Keywords
- Folate Status, Folate Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- University of Florida, Emory University
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Apr 2013 (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.
The objective of this study is to identify genes whose expression is potentially modifiable due to changes in folate intake and help delineate mechanisms accounting for the variability in individual response to folic acid supplementation. The study will be conducted in normal weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic acid.
It is hypothesized that (1) a change in folate status, induced by the supplementation, will influence the DNA methylation of specific genes and (2) the DNA methylation response to folic acid supplementation may differ between the normal weight and the obese women of childbearing age.
Detailed description
This study will be conducted in two phases. An initial screening study will be performed to determine folate status, MTHFR677 genotype and body composition of potential participants of the intervention study. Both folate status and MTHFR677 genotype are known independent predictors of response to folic acid supplementation. Blood samples will be collected, after an overnight fast, for determination of serum folate concentration and for MTHFR677 genotyping. Body composition and 24-hr dietary recalls will also be conducted during the screening visit.
The second phase is an eight week supplementation trial with 800 mcg/day folic acid. Screened individuals determined to have a serum folate < 30 nmol/L (< 50th percentile of NHANES 1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion in the supplementation trial. Participants will be instructed to avoid dietary supplements, fortified ready-to-eat cereals, and other high folate content foods during intervention. Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8 weeks of supplementation for determination of primary (DNA methylation profile) and secondary (nutritional, metabolic and health status biomarkers) outcome measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic Acid Normal Weight | Experimental | Dietary Supplement: Folic acidFolic acid, tablet, 800 mcg, daily, eight weeks. Normal Weight individuals, each will serve as her own control. |
| Folic acid Obese | Experimental | Dietary Supplement: Folic acidFolic acid, tablet, 800 mcg, daily, eight weeks. Obese individuals, each will serve as her own control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Screening Phase:
- Female 18-40 yr
- Body Mass index 18.5 to 24.9 or > 30 kg/m2
- Intervention Study:
- Serum folate < 30 nmol/L
Key exclusion criteria (12 listed)
- Currently pregnant, pregnancy within past 12 months
- Greater than 2 previous pregnancies
- Use of prescription drugs other than oral contraceptives
- Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
- Acute illness (pneumonia, urinary tract infection, mononucleosis)
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 |
|---|---|---|
| Folic acidParticipants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count. | Dietary supplement | Folic Acid Normal Weight, Folic acid Obese |
Primary outcome
Cell-type-specific DNA methylation
Time frame: Baseline, 4 weeks and 8 weeks
Change in DNA methylation in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined in DNA isolated from specific white blood cell types. Microarray analysis will be used to assess changes in multiple methylation sites within regulatory pathways for folate metabolism and/or development. Each subject will serve as her own control.
Gene-specific DNA methylation
Time frame: Baseline, 4 weeks and 8 weeks
Change in DNA methylation in response to 4 or 8 weeks supplementation with 800 mcg/day of folic acid will be determined in DNA isolated from whole blood . Microarray analysis will be used to assess changes in multiple methylation sites of specific genes within regulatory pathways for folate metabolism and/or development. Each subject will serve as her own control.
3 secondary outcomes
Serum folate
Time frame: Baseline, 4 weeks and 8 weeks
Red Blood Cell (RBC) Folate
Time frame: Baseline, 4 weeks and 8 weeks
Body Composition
Time frame: Baseline and 8 weeks
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 4 Jul 2016.
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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.
Lynn B Bailey, PhD principal investigator
University of Georgia
Dorothy Hausman, PhD study director
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid in people with Obesity, run by University of Georgia at 1 site in United States.
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 6 inclusion and 12 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 4 Jul 2016. 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 United States. 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. 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?
Cell-type-specific DNA methylation (time frame: Baseline, 4 weeks and 8 weeks). 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?
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 4 Jul 2016.