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Completed

NCT Number: NCT04016090

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

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

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Folic Acid

Dietary Supplement

Folic acid (5 mg)

Placebo

Other

Placebo capsule

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Post-menopausal Women.

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2019
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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