Vitamin C to Reduce Morning Cardiovascular Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2022-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Vitamin C and Placebo doses will be blinded by the research pharmacy, so that participants and investigators are masked to the identity of the tablet. Data analysis will be blinded to the conditions as well until the completion of the study.

Study Groups

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Vitamin C then Placebo

Participants will receive a 1.5g dose of Ascorbic Acid upon wake for the first visit, and a placebo tablet on the second visit.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

1.5g Ascorbic Acid

Placebo

Intervention Type OTHER

Inactive placebo to mimic 1.5g ascorbic acid.

Placebo then Vitamin C

Participants will receive a placebo tablet upon wake for the first visit, and a 1.5g dose of Ascorbic Acid on the second visit.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

1.5g Ascorbic Acid

Placebo

Intervention Type OTHER

Inactive placebo to mimic 1.5g ascorbic acid.

Interventions

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Vitamin C

1.5g Ascorbic Acid

Intervention Type DIETARY_SUPPLEMENT

Placebo

Inactive placebo to mimic 1.5g ascorbic acid.

Intervention Type OTHER

Other Intervention Names

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Ascorbic Acid

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes