Vitamin C to Reduce Morning Cardiovascular Risk

Cardiovascular Risk Factor Clinical Trial

Official title:

Chronotherapeutic Use of Vitamin C to Reduce Morning Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290612
• Other study ID #: IRB 00017294
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. Primary dependent variables are markers of cardiovascular risk including vascular endothelial function and oxidative stress.

Description:

The investigators plan to test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. This pilot study is in healthy middle aged adults without a history of CV disease.

Participants will spend two nights in an inpatient hospital suite at Hatfield Research Center. Upon awakening in the morning, they will either ingest Vitamin C or placebo in a randomized order. This will be followed by moderate intensity exercise, recovery, and discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy participants

• Normal weight or overweight but not obese (18.5<BMI<33 kg/m2)

Exclusion Criteria:

• History of smoking/tobacco use

• Current prescription/non-prescription medications or drugs of abuse

• Acute, chronic, or debilitating medical conditions

• History of working irregular day and night hours, regular night work, or rotating shift work for the six months prior to the study.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Vitamin C
1.5g Ascorbic Acid

Other:
• Placebo
Inactive placebo to mimic 1.5g ascorbic acid.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Endothelial Function	Vascular endothelial function will be measured as flow-mediated dilation (FMD). We will measure brachial artery FMD immediately upon awakening in a constant posture following an overnight fast using the standard guidelines and protocol.	Approximately three months
Primary	Oxidative stress	Oxidative stress will be measured as malondialdehyde (MDA) adducts from Ethylenediaminetetraacetic acid (EDTA) plasma. Higher values may indicate increased oxidative stress.	Approximately three months
Primary	Plasma Vitamin C and Tetrahydrobiopterin	We will measure Vitamin C levels in the plasma to ensure that the levels are increased after supplementation, and to control for baseline levels. We will measure tetrahydrobiopterin (BH4) from plasma to test if levels are increased upon administration of Vitamin C.	Approximately three months
Secondary	Platelet aggregation	Platelet aggregation will be measured using Chronolog 560 VS Platelet aggregometer as an indicator of how well blood clots or clumps together. Higher values may indicate increased cardiovascular risk.	Approximately three months
Secondary	Plasminogen activator inhibitor -1	Plasminogen activator inhibitor-1 (PAI-1) will be measured from plasma as a blood inflammatory marker. Higher values may indicate increased cardiovascular risk.	Approximately three months