Healthy AgingNCT04016090
An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Seniors
A study testing Folic Acid in people with Healthy Aging and Aging, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate if folic acid improves endothelial sensitivity to shear stress in post-menopausal women. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Aging, Menopause
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2019to 3 Apr 2024
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 1-year amenorrhea
- Body mass index ≤ 30 kg/m2
- Resting blood pressure < 140 / < 90 mmHg
- Non-smoker (≥ 1-year)
Who cannot join
- Diagnosis of cardiac, vascular, respiratory, neurological or metabolic disease and/or a prescription of medications for the treatment of such diseases.
- For female participants, hormonal replacement therapy within 1 year of enrolment in the study.
- For female participants, having undergone an ovariectomy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Post-menopausal Women.
The purpose of this study is to evaluate if folic acid improves endothelial sensitivity to shear stress in post-menopausal women.
Read the detailed description
Cardiovascular diseases (CVD) have remained the leading cause of death globally for the last 15 years. Considering that advancing age is the primary risk factor for CVD, an increasingly aging population is expected to result in unprecedented levels of CVD. It therefore remains crucial to develop effective prevention or treatment strategies to reduce the impending health and economic burden of CVD.
Exercise is arguably the best intervention for the prevention and/or treatment of CVD. A key adaptation underlying the cardiovascular benefits of exercise is to offset and reverse age-related reductions in vascular function. Studies have demonstrated, at least in men, that active older adults demonstrate preserved vascular function relative to their sedentary peers and that exercise training interventions improve vascular function in previously sedentary older adults. However, these studies have almost exclusively been performed in men. In contrast, the few studies performed in older women consistently demonstrate that active women do not demonstrate preserved vascular function relative to their sedentary peers and that exercise training interventions do not improve vascular function in previously sedentary women. This observation has been attributed to the loss of oestrogens that accompanies menopause. Although the mechanisms have not been fully elicited, it is possible that the loss of oestrogens desensitizes the endothelium to the physiological stimuli that result in improved vascular function with exercise training. Indeed, exercise improves vascular function in previously sedentary older women when it is combined with oestrogen replacement. Nevertheless, chronic oestrogen replacement therapy is not a viable intervention as it is associated with an increased risk of breast cancer. Alternative solutions to restore the beneficial effects of exercise on vascular function in post-menopausal women are thus urgently needed.
The overall objective of this project is to determine if folic acid, an over-the-counter supplement that has been shown to provide beneficial vascular adaptations, can be used to improve vascular function in post-menopausal women. It is hypothesized that folic acid will improve blood vessel function in post-menopausal women and age-matched males.
- Conditions
- Healthy Aging, Aging, Menopause
- Being tested
- Folic Acid, Placebo
- Keywords
- Postmenopausal women, Vascular health, Folic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDietary supplement
Folic acid (5 mg)
PlaceboOther
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment | Placebo comparator | Participant will be asked to ingest a placebo capsule. Receives: Other: Placebo |
| Folic Acid | Experimental | Participant will be asked to ingest a capsule containing 5 mg of folic acid. Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial sensitivity to shear rate
Change in brachial artery diameter for given levels of shear rate during rhythmic handgrip exercise
Measured: Measured 2 hours after placebo or folic acid consumption
Secondary outcomes (1)
Neurovascular transduction
Change in femoral artery diameter for a given increase in muscle sympathetic nerve activity during isometric handgrip exercise to fatigue.
Measured: Measured 2 hours after placebo or folic acid consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start9 Sep 2019
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Gagnon, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016090
- Sponsor's protocol ID
- ICM-2019-2596
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2019
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual data will be de-identified and available to the public through publications, media articles and conference presentations
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Post-menopausal Women.
- ClinicalTrials.gov ID
- NCT04016090
- Acronym / sponsor ID
- ICM-2019-2596
- Conditions
- Healthy Aging, Aging, Menopause
- Keywords
- Postmenopausal women, Vascular health, Folic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 11 Jul 2019 (actual)
- 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 purpose of this study is to evaluate if folic acid improves endothelial sensitivity to shear stress in post-menopausal women.
Detailed description
Cardiovascular diseases (CVD) have remained the leading cause of death globally for the last 15 years. Considering that advancing age is the primary risk factor for CVD, an increasingly aging population is expected to result in unprecedented levels of CVD. It therefore remains crucial to develop effective prevention or treatment strategies to reduce the impending health and economic burden of CVD.
Exercise is arguably the best intervention for the prevention and/or treatment of CVD. A key adaptation underlying the cardiovascular benefits of exercise is to offset and reverse age-related reductions in vascular function. Studies have demonstrated, at least in men, that active older adults demonstrate preserved vascular function relative to their sedentary peers and that exercise training interventions improve vascular function in previously sedentary older adults. However, these studies have almost exclusively been performed in men. In contrast, the few studies performed in older women consistently demonstrate that active women do not demonstrate preserved vascular function relative to their sedentary peers and that exercise training interventions do not improve vascular function in previously sedentary women. This observation has been attributed to the loss of oestrogens that accompanies menopause. Although the mechanisms have not been fully elicited, it is possible that the loss of oestrogens desensitizes the endothelium to the physiological stimuli that result in improved vascular function with exercise training. Indeed, exercise improves vascular function in previously sedentary older women when it is combined with oestrogen replacement. Nevertheless, chronic oestrogen replacement therapy is not a viable intervention as it is associated with an increased risk of breast cancer. Alternative solutions to restore the beneficial effects of exercise on vascular function in post-menopausal women are thus urgently needed.
The overall objective of this project is to determine if folic acid, an over-the-counter supplement that has been shown to provide beneficial vascular adaptations, can be used to improve vascular function in post-menopausal women. It is hypothesized that folic acid will improve blood vessel function in post-menopausal women and age-matched males.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment | Placebo comparator | Other: PlaceboParticipant will be asked to ingest a placebo capsule. |
| Folic Acid | Experimental | Dietary Supplement: Folic AcidParticipant will be asked to ingest a capsule containing 5 mg of folic acid. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 1-year amenorrhea
- Body mass index ≤ 30 kg/m2
- Resting blood pressure < 140 / < 90 mmHg
- Non-smoker (≥ 1-year)
Key exclusion criteria (3 listed)
- Diagnosis of cardiac, vascular, respiratory, neurological or metabolic disease and/or a prescription of medications for the treatment of such diseases.
- For female participants, hormonal replacement therapy within 1 year of enrolment in the study.
- For female participants, having undergone an ovariectomy.
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 AcidFolic acid (5 mg) | Dietary supplement | Folic Acid |
| PlaceboPlacebo capsule | Other | Placebo treatment |
Primary outcome
Endothelial sensitivity to shear rate
Time frame: Measured 2 hours after placebo or folic acid consumption
Change in brachial artery diameter for given levels of shear rate during rhythmic handgrip exercise
1 secondary outcome
Neurovascular transduction
Time frame: Measured 2 hours after placebo or folic acid consumption
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 12 Dec 2024.
- Individual participant dataSharing planned: No. All individual data will be de-identified and available to the public through publications, media articles and conference presentations
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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 Folic Acid in people with Healthy Aging and Aging, run by Montreal Heart Institute at 1 site in Canada.
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 4 inclusion and 3 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 12 Dec 2024. 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 Canada. 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?
Endothelial sensitivity to shear rate (time frame: Measured 2 hours after placebo or folic acid consumption). 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 12 Dec 2024.