Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363305
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-09
Brief Title:
Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health
Sponsor:
Skidmore College
Organization:
Skidmore College
Study Overview
Official Title:
Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide NO bioavailability its effect on key markers of cardiovascular CV health including BP macro- and microvascular function and arterial stiffness This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials
Detailed Description:
Specific Aim 1 Determine the sex-specific effects of dietary capsaicin on central and peripheral blood pressure and arterial stiffness The investigators hypothesize that dietary capsaicin intervention 6 week will improve BP and arterial stiffness likely in a sex-dependent manner The investigators will measure heart rate variability and excretion of capsaicin and metabolites to ascertain bioavailability and understand the mechanistic role of the autonomic nervous system in capsaicins effect on BP
Specific Aim 2 Assess whether dietary capsaicin effects on vascular function is sex-specific The investigators hypothesize that dietary capsaicin intervention 6 week will improve NO bioavailability through improved redox balance and lowered asymmetric dimethylarginine thereby improving peripheral vascular function likely in a sex-dependent manner
Utilizing a double-blind randomized placebo-controlled design the investigators will investigate whether there is sex-specificity in the effects of a 6-week dietary capsaicin intervention on nitric oxide NO bioavailability BP vascular function and arterial stiffness
Specific Aim 2 Assess whether dietary capsaicin effects on vascular function is sex-specific The investigators hypothesize that dietary capsaicin intervention 6 week will improve NO bioavailability through improved redox balance and lowered asymmetric dimethylarginine thereby improving peripheral vascular function likely in a sex-dependent manner
Utilizing a double-blind randomized placebo-controlled design the investigators will investigate whether there is sex-specificity in the effects of a 6-week dietary capsaicin intervention on nitric oxide NO bioavailability BP vascular function and arterial stiffness
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