Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416228
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-29
Brief Title:
Beetroot Juice NO Cold Study
Sponsor:
Southern Methodist University
Organization:
Southern Methodist University
Study Overview
Official Title:
Beetroot Juice Supplement for Boosting Mucosal Immunity - The NO Cold Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NCS
Brief Summary:
Currently there is a lack of evidence-based prevention strategies for respiratory infection and management of these conditions can be costly to the public Airway nitric oxide provides a first line of defense against pathogens and beetroot juice a source of dietary nitrate has been shown to elevate nitric oxide The main objective of this project is to demonstrate that one week of supplementation with beetroot juice elevates airway nitric oxide during stressful periods in young adults and thereby can protect against respiratory viral infections
Detailed Description:
Study Title Beetroot Juice Supplement for Boosting Mucosal Immunity The NO Cold Study
Objectives Aim 1 Demonstrate that a 7-day trial of daily beetroot juice or nitrate depleted placebo beetroot juice is feasible with acceptable retention and adherence during a period of real-life stress using adherence monitoring of beetroot juice intake by cell phone recorded video acceptable burdensomeness for participants and success of team coordination and study logistics should also be demonstrated
Aim 2 Generate initial estimates of effect size for a elevations in exhaled nitric oxide FENO and b the correlation between changes in FENO and both infection reduction and cold symptom reduction biological signature
Aim 3 a Examine if 2 daily doses of beetroot juice are more potent than 1 daily dose in elevating FENO and b investigate whether each beetroot juice dosage 1 dose and 2 doses increases FENO more than the placebo
Exploratory aims Explore sex as a moderator of all the Aims Also explore effects of competitorsinhibitors of NO arginase asymmetric dimethylarginine in a reducing FENO under stress and b whether beetroot juice buffers any of these potential adverse effects on FENO c investigate whether effects of stress cortisol which negatively impact NO cold symptoms and respiratory infections are also buffered by beetroot juice
Design and Outcomes This is a double-blind placebo controlled clinical trial to test the efficacy of beetroot juice as elevating airway NO which is associated with reduced cold symptoms and respiratory viral infection rates in undergraduate students aged 18-30
Interventions and Duration Participants will be receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice 2 active daily doses of beetroot juice or 2 daily doses of nitrate-depleted placebo beetroot
Cold symptoms will be explored by questionnaire at baseline in a low stress period during the semester and subsequently twice during the final exam period once at an early stage of the finals days 1-3 of the final exam period and once at a later stage days 4-6 A follow-up online questionnaire packet will be administered 3 days after the last final day FENO sampling for viral PCR salivary cortisol and exhaled breath condensate will be undertaken at baseline early finals and late finals in-person assessments are not feasible at follow-up because students leave campus after finals
Sample Size and Population The sample size is 150 students n66 at SMU site n84 at Baylor site Female and male students 18-30 years old will be recruited from Baylor and SMU The investigators will make an extra effort to guarantee equal representation of both genders Participants can be from any ethnic or cultural background as long as they can understand and read English adequately The student population of both universities combined is diverse 285-385 minorities
The investigators will stratify by sex and by site to randomize participants to receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice 2 active daily doses of beetroot juice or 2 daily doses of nitrate-depleted placebo beetroot juice n50 per group
Objectives Aim 1 Demonstrate that a 7-day trial of daily beetroot juice or nitrate depleted placebo beetroot juice is feasible with acceptable retention and adherence during a period of real-life stress using adherence monitoring of beetroot juice intake by cell phone recorded video acceptable burdensomeness for participants and success of team coordination and study logistics should also be demonstrated
Aim 2 Generate initial estimates of effect size for a elevations in exhaled nitric oxide FENO and b the correlation between changes in FENO and both infection reduction and cold symptom reduction biological signature
Aim 3 a Examine if 2 daily doses of beetroot juice are more potent than 1 daily dose in elevating FENO and b investigate whether each beetroot juice dosage 1 dose and 2 doses increases FENO more than the placebo
Exploratory aims Explore sex as a moderator of all the Aims Also explore effects of competitorsinhibitors of NO arginase asymmetric dimethylarginine in a reducing FENO under stress and b whether beetroot juice buffers any of these potential adverse effects on FENO c investigate whether effects of stress cortisol which negatively impact NO cold symptoms and respiratory infections are also buffered by beetroot juice
Design and Outcomes This is a double-blind placebo controlled clinical trial to test the efficacy of beetroot juice as elevating airway NO which is associated with reduced cold symptoms and respiratory viral infection rates in undergraduate students aged 18-30
Interventions and Duration Participants will be receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice 2 active daily doses of beetroot juice or 2 daily doses of nitrate-depleted placebo beetroot
Cold symptoms will be explored by questionnaire at baseline in a low stress period during the semester and subsequently twice during the final exam period once at an early stage of the finals days 1-3 of the final exam period and once at a later stage days 4-6 A follow-up online questionnaire packet will be administered 3 days after the last final day FENO sampling for viral PCR salivary cortisol and exhaled breath condensate will be undertaken at baseline early finals and late finals in-person assessments are not feasible at follow-up because students leave campus after finals
Sample Size and Population The sample size is 150 students n66 at SMU site n84 at Baylor site Female and male students 18-30 years old will be recruited from Baylor and SMU The investigators will make an extra effort to guarantee equal representation of both genders Participants can be from any ethnic or cultural background as long as they can understand and read English adequately The student population of both universities combined is diverse 285-385 minorities
The investigators will stratify by sex and by site to randomize participants to receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice 2 active daily doses of beetroot juice or 2 daily doses of nitrate-depleted placebo beetroot juice n50 per group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None