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

NCT04016090 | Completed

• 1 other identifier: ICM-2019-2596
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Aging; Aging; Menopause

Keywords

Postmenopausal women; Vascular health; Folic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neurovascular transduction

  Measured 2 hours after placebo or folic acid consumption

Study Arms (2)

Placebo treatment

PLACEBO COMPARATOR

Participant will be asked to ingest a placebo capsule.

Other: Placebo

Folic Acid

EXPERIMENTAL

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

Dietary Supplement: Folic Acid

Interventions

Folic Acid DIETARY_SUPPLEMENT

Folic acid (5 mg)

Folic Acid

Placebo OTHER

Placebo capsule

Placebo treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 1-year amenorrhea
• Body mass index ≤ 30 kg/m2
• Resting blood pressure \< 140 / \< 90 mmHg
• Non-smoker (≥ 1-year)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 11, 2019
• Study Start: September 9, 2019
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)