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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016090
• Other study ID #: ICM-2019-2596
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Montreal Heart Institute
• Contact: Daniel Gagnon, PhD
• Phone: 1-514-374-1480
• Email: daniel.gagnon.3[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Healthy Aging
• Menopause

Intervention

Dietary Supplement:
• Folic Acid
Folic acid (5 mg)

Other:
• Placebo
Placebo capsule

Locations

Country	Name	City	State
Canada	Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial sensitivity to shear rate	Change in brachial artery diameter for given levels of shear rate during rhythmic handgrip exercise	Measured 2 hours after placebo or folic acid consumption
Secondary	Neurovascular transduction	Change in femoral artery diameter for a given increase in muscle sympathetic nerve activity during isometric handgrip exercise to fatigue.	Measured 2 hours after placebo or folic acid consumption