Pre HypertensionNCT06363305
Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health
A study testing Dietary capsules in people with Pre Hypertension and Hypertension, run by Skidmore College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre Hypertension, Hypertension
- What is being tested?
- Dietary capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- relatively healthy (other than elevated blood pressure) non-smoking men and women over the age of 18 from the local community
Who cannot join
- Women who are without a period (not due to a birth control method, intrauterine device or menopause), are pregnant, attempting to conceive, or are breastfeeding will be excluded.
- uncontrolled hypertension
- Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment).
- Any participants with excessive sensitivity to spicy foods or fiber (psyllium husk) will be excluded
- Participants with food allergies will be excluded
- Participants who have difficulty swallowing or swallowing pills may be excluded.
- Participants who suffer from heartburn, hiatal hernia, gastritis, or peptic ulcer disease may be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Skidmore College
Saratoga Springs, New York, 12866
Stephen Ives, Ph.D., 518-580-8366, sives@skidmore.edu
About this study
Official title: Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health: A Randomized Controlled Trial
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.
Read the 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 capsaicin's 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.
- Conditions
- Pre Hypertension, Hypertension
- Being tested
- Dietary capsules
- Keywords
- vascular stiffness, blood pressure, vascular function
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary capsulesDietary supplement
Daily doses of dietary capsaicin or placebo in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Dietary Capsaicin | Experimental | Over-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA) Receives: Dietary Supplement: Dietary capsules |
| Placebo | Placebo comparator | The placebo will be 2 x 400-500 mg fiber (800 mg psyllium husk) capsules which were chosen to be of similar appearance (size, coloration, and texture). Receives: Dietary Supplement: Dietary capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure and Vascular Stiffness
The investigators will assess peripheral and estimated central blood pressures and vascular stiffness using pulse wave analysis.
Measured: Baseline, 24 hours, and 6-weeks
Heart Rate (HR) and HR variability (HRV)
The investigators will assess HR and HRV using electrocardiogram and standard techniques to determine time and frequency domain estimates of HRV.
Measured: Baseline, 24 hours, and 6-weeks
Flow Mediated Dilation
The investigators will assess brachial artery flow-mediated dilation using ischemia-reperfusion and ultrasound doppler to assess the dilatory capacity and reactive hyperemia.
Measured: Baseline, 24 hours, and 6-weeks
Passive Leg Movement Hyperemia
The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler.
Measured: Baseline, 24 hours, and 6-weeks
Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test
The investigators will assess the metabolic capacity and vascular reactivity using ischemia-reperfusion and NIRS
Measured: Baseline, 24 hours, and 6-weeks
Secondary outcomes (2)
Urinary Capsaicinoids
The investigators will collect urine to determine urinary capsaicin and associated metabolites to understand bioavailability and potential relation to function.
Measured: Baseline, 24 hours, and 6-weeks
Blood Lipids
The investigators will collect blood to determine blood lipids (cholesterol) and glucose.
Measured: Baseline and 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start8 Jul 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363305
- Sponsor's protocol ID
- 2402-1139
- Status last verified
- Jul 2024
- First submitted
- 9 Apr 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only deidentified data may be shared with the sponsor or research community through appropriate data repositories.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06363305
- Acronym / sponsor ID
- 2402-1139
- Conditions
- Pre Hypertension, Hypertension
- Keywords
- vascular stiffness, blood pressure, vascular function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 capsaicin's 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Dietary Capsaicin | Experimental | Dietary Supplement: Dietary capsulesOver-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA) |
| Placebo | Placebo comparator | Dietary Supplement: Dietary capsulesThe placebo will be 2 x 400-500 mg fiber (800 mg psyllium husk) capsules which were chosen to be of similar appearance (size, coloration, and texture). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- relatively healthy (other than elevated blood pressure) non-smoking men and women over the age of 18 from the local community
Key exclusion criteria (7 listed)
- Women who are without a period (not due to a birth control method, intrauterine device or menopause), are pregnant, attempting to conceive, or are breastfeeding will be excluded.
- uncontrolled hypertension
- Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment).
- Any participants with excessive sensitivity to spicy foods or fiber (psyllium husk) will be excluded
- Participants with food allergies will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary capsulesDaily doses of dietary capsaicin or placebo in capsule form | Dietary supplement | Dietary Capsaicin, Placebo |
Primary outcome
Blood Pressure and Vascular Stiffness
Time frame: Baseline, 24 hours, and 6-weeks
The investigators will assess peripheral and estimated central blood pressures and vascular stiffness using pulse wave analysis.
Heart Rate (HR) and HR variability (HRV)
Time frame: Baseline, 24 hours, and 6-weeks
The investigators will assess HR and HRV using electrocardiogram and standard techniques to determine time and frequency domain estimates of HRV.
Flow Mediated Dilation
Time frame: Baseline, 24 hours, and 6-weeks
The investigators will assess brachial artery flow-mediated dilation using ischemia-reperfusion and ultrasound doppler to assess the dilatory capacity and reactive hyperemia.
Passive Leg Movement Hyperemia
Time frame: Baseline, 24 hours, and 6-weeks
The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler.
Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test
Time frame: Baseline, 24 hours, and 6-weeks
The investigators will assess the metabolic capacity and vascular reactivity using ischemia-reperfusion and NIRS
2 secondary outcomes
Urinary Capsaicinoids
Time frame: Baseline, 24 hours, and 6-weeks
Blood Lipids
Time frame: Baseline and 6-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No. Only deidentified data may be shared with the sponsor or research community through appropriate data repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary capsules in people with Pre Hypertension and Hypertension, run by Skidmore College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Ives, PhD (5185808366, sives@skidmore.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure and Vascular Stiffness (time frame: Baseline, 24 hours, and 6-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.