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An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Seniors

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ClinicalTrials.gov Identifier: NCT04016090
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Gagnon, Montreal Heart Institute

Brief Summary:
The purpose of this study is to evaluate if folic acid improves endothelial sensitivity to shear stress in post-menopausal women.

Condition or disease Intervention/treatment Phase
Healthy Aging Aging Menopause Dietary Supplement: Folic Acid Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Post-menopausal Women.
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo treatment
Participant will be asked to ingest a placebo capsule.
Other: Placebo
Placebo capsule

Experimental: Folic Acid
Participant will be asked to ingest a capsule containing 5 mg of folic acid.
Dietary Supplement: Folic Acid
Folic acid (5 mg)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Neurovascular transduction [ Time Frame: Measured 2 hours after placebo or folic acid consumption ]
    Change in femoral artery diameter for a given increase in muscle sympathetic nerve activity during isometric handgrip exercise to fatigue.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 1-year amenorrhea
  • Body mass index ≤ 30 kg/m2
  • Resting blood pressure < 140 / < 90 mmHg
  • Non-smoker (≥ 1-year)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016090


Contacts
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Contact: Daniel Gagnon, PhD 1-514-374-1480 ext 4205 daniel.gagnon.3@umontreal.ca
Contact: Nicholas Ravanelli, PhD 1-514-374-1480 ext 4344 nick.ravanelli@gmail.com

Locations
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Canada, Quebec
Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute Recruiting
Montréal, Quebec, Canada, H1T1N6
Contact: Daniel Gagnon, PhD    1-514-374-1480 ext 4205    daniel.gagnon.3@umontreal.ca   
Sponsors and Collaborators
Montreal Heart Institute

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Responsible Party: Daniel Gagnon, Principal Investigator, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT04016090     History of Changes
Other Study ID Numbers: ICM-2019-2596
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All individual data will be de-identified and available to the public through publications, media articles and conference presentations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Daniel Gagnon, Montreal Heart Institute:
Postmenopausal women
Vascular health
Folic acid

Additional relevant MeSH terms:
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Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs