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.

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

Study Overview

• Status: Recruiting
• Conditions: Menopause; Aging; Healthy Aging
• Intervention / Treatment: Other: Placebo; Dietary supplement: Folic Acid

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Gagnon, PhD; Phone Number: 4205 1-514-374-1480; Email: daniel.gagnon.3@umontreal.ca
• Study Contact Backup: Name: Audrey-Ann Bartlett, BSc; Phone Number: 4344 1-514-374-1480; Email: Audrey-Ann.Bartlett@uqtr.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T1N6
      • Recruiting
      • Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute
      • Contact: Daniel Gagnon, PhD; Phone Number: 4205 1-514-374-1480; Email: daniel.gagnon.3@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Folic acid; Postmenopausal women; Vascular health
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: ICM-2019-2596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All individual data will be de-identified and available to the public through publications, media articles and conference presentations

Drug and device information, study documents

• 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