- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341308
Does Vitamin C Increase the Body Heat Generated By The Nervous System?
The goals of this clinical trial are to determine whether or not vitamin C is able to: (1) increase the body heat generated by the sympathetic nervous system; and, (2) increase circulating vitamin D concentration during sympathetic nervous system stimulation in adult humans aged 18-40 years who meet the criteria for overweight based on body mass index. The main question it aims to answer are:
- By how much does body temperature increase during stimulation of beta-adrenergic receptors when vitamin C is given.
- By how much does circulating vitamin D concentration increase during stimulation of beta-adrenergic receptors when vitamin C is given.
Participants will will be asked to:
- undergo measures of body temperature
- have blood sampled on two separate occasions: once during stimulation of beta adrenergic receptors, and once during stimulation of beta-adrenergic receptors while also been given vitamin C.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523
- Colorado State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-40 years (inclusive)
- Body mass index greater than or equal to 25 kg/m2 and less than 30 kg/m2
- Weight stable (no change in body mass greater than 5 Lbs. within the previous 6 months.
- Willing to abstain from caffeine and alcohol for 24-hours prior to two different study visits
- Competency in English as assessed by comprehension of the Informed Consent. This is study involves invasive procedures and infusion of a systemic vasoactive agent (isoproterenol); for safety reasons, the ability for clear and rapid communication will be necessary between the research participants and the investigators.
Exclusion Criteria:
- History of autonomic, cardio-pulmonary, and/or metabolic disease (including heart failure, hypertension, arrhythmia, vascular disease, and/or diabetes)
- Pregnancy or breast feeding
- Habitual use of tobacco/nicotine products or recreational drugs (2 or more uses within the previous month)
- History of a "sulfite allergy" as it is a relative contraindication to isoproteronol use.
- Has ingested vitamin supplements and/or antioxidant supplements during the previous 4-weeks (e.g. Vitamin C, Vitamin E, Multi-vitamins, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Response to beta-adrenergic stimulation without vitamin C
Isoproterenol will be infused with saline only
|
|
|
Experimental: Adding vitamin C to beta-adrenergic receptor stilmulation
Isoproterenol will be infused with vitamin C
|
Vitamin C will be co-infused with isoproterenol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Temperature
Time Frame: Prior to and immediately after a dose of isoproterenol. This corresponds to 0 minutes (baseline) and immediately after each dose of isoproterenol at minutes 30, 60 and 90.
|
Body temperature will be measured using an oral thermometer
|
Prior to and immediately after a dose of isoproterenol. This corresponds to 0 minutes (baseline) and immediately after each dose of isoproterenol at minutes 30, 60 and 90.
|
|
Vitamin D
Time Frame: Prior to and immediately after a dose of isoproterenol. This corresponds to 0 minutes (baseline) and immediately after each dose of isoproterenol at minutes 30, 60 and 90.
|
Circulating vitamin D concentration
|
Prior to and immediately after a dose of isoproterenol. This corresponds to 0 minutes (baseline) and immediately after each dose of isoproterenol at minutes 30, 60 and 90.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Bell, PhD, Colorado State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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