An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Seniors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04016090|
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Aging Aging Menopause||Dietary Supplement: Folic Acid Other: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
Placebo Comparator: Placebo treatment
Participant will be asked to ingest a 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)
- 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
- 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.
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
|Contact: Daniel Gagnon, PhD||1-514-374-1480 ext email@example.com|
|Contact: Nicholas Ravanelli, PhD||1-514-374-1480 ext firstname.lastname@example.org|
|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 email@example.com|