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

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

Sponsors

Lead Sponsor: Montreal Heart Institute

Source 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.

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.

Overall Status Recruiting
Start Date 2019-05-16
Completion Date 2022-12-31
Primary Completion Date 2022-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Endothelial sensitivity to shear rate Measured 2 hours after placebo or folic acid consumption
Secondary Outcome
Measure Time Frame
Neurovascular transduction Measured 2 hours after placebo or folic acid consumption
Enrollment 40
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Folic Acid

Description: Folic acid (5 mg)

Arm Group Label: Folic Acid

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo capsule

Arm Group Label: Placebo treatment

Eligibility

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.

Gender:

All

Minimum Age:

50 Years

Maximum Age:

80 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Daniel Gagnon, PhD

Phone: 1-514-374-1480

Phone Ext.: 4205

Email: [email protected]

Location
Facility: Status: Contact: Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute Daniel Gagnon, PhD 1-514-374-1480 4205 [email protected]
Location Countries

Canada

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Montreal Heart Institute

Investigator Full Name: Daniel Gagnon

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Placebo treatment

Type: Placebo Comparator

Description: Participant will be asked to ingest a placebo capsule.

Label: Folic Acid

Type: Experimental

Description: Participant will be asked to ingest a capsule containing 5 mg of folic acid.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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