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

NCT ID: NCT04016090

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2024-04-03

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.

Conditions

Healthy Aging; Aging; Menopause

Keywords

Postmenopausal women; Vascular health; Folic acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo treatment

Participant will be asked to ingest a placebo capsule.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo capsule

Folic Acid

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

Group Type: EXPERIMENTAL

Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

Folic acid (5 mg)

Interventions

Folic Acid

Folic acid (5 mg)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsule

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Daniel Gagnon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

ICM-2019-2596

Identifier Type: -

Identifier Source: org_study_id