MenopauseNCT05600413
Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women
A study testing L-Citrulline in people with Menopause, run by Texas Tech University at 1 site in United States.
Trial summary
The objective of this project is to provide evidence that L-Citrulline (L-CIT) supplementation can improve vascular function at rest and in response to exercise in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- L-Citrulline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 27 Apr 2022
- 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 50 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal (absence of menstruation > 1 year) between the ages of 50 - 79 years.
- Sedentary ( < 120 minutes of exercise/week)
- Resting systolic blood pressure < 150 mmHg and diastolic blood pressure < 90 mmHg
- Not participating as a subject in another study for at least 2 months prior to the study and for the duration of the study
- Willingness to abstain from food supplements 1 month prior to the start of the study and throughout the duration of the study
Who cannot join
- Body mass index ≥ 40
- Currently taking more than one vasoactive drug for blood pressure control
- Cardiometabolic diseases or other chronic diseases
- Taking hormone replacement therapy 3 months prior to the study
- Current or prior use of tobacco products
- More than a moderate intake of alcohol
- Use of medications and/or supplements that may affect outcome variables
- Musculoskeletal disorders that will prevent exercise performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L-Citrulline Supplementation to Improve Vascular Function and Responsiveness at Rest and During Exercise in Postmenopausal Women
The objective of this project is to provide evidence that L-Citrulline (L-CIT) supplementation can improve vascular function at rest and in response to exercise in postmenopausal women.
Read the detailed description
L-CIT is a non-essential amino acid that is a precursor to L-arginine, the substrate used to produce an important vasodilatory molecule called nitric oxide. The purpose of this study is to identify the effects of 6 grams of L-CIT for 4 weeks on vascular function (endothelial function, blood flow, muscle oxygenation, and blood pressure) at rest and in response to different stressors (cold pressor test, isometric and dynamic exercise).
- Conditions
- Menopause
- Being tested
- L-Citrulline, Placebo
- Keywords
- Endothelial function, Blood pressure, Blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CitrullineDietary supplement
4 weeks of L-Citrulline supplementation (6 grams/day)
PlaceboDietary supplement
4 weeks of Placebo (crystalline cellulose)
| Study group | Role | What they receive |
|---|---|---|
| L-Citrulline | Experimental | L-Citrulline: 6 grams/day Receives: Dietary Supplement: L-Citrulline |
| Placebo | Placebo comparator | Crystalline Cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular endothelial function
Endothelial function will be assessed via reactive hyperemic index using the EndoPAT device.
Measured: 4 weeks
Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during metaboreflex activation
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff during isometric handgrip exercise and postexercise muscle ischemia.
Measured: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis during metaboreflex activation
The speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial applanation tonometry and a validated transfer function (AtCor Medical) during isometric handgrip exercise and postexercise muscle ischemia.
Measured: 4 weeks
Blood flow during dynamic exercise
Blood flow will be measured using ultrasound in the superficial femoral and brachial artery during dynamic exercises superimposed with the cold pressor test.
Measured: 4 weeks
Muscle oxygenation during dynamic exercise
Muscle oxygenation will be measured using near infrared spectroscopy during dynamic exercises superimposed with the cold pressor test.
Measured: 4 weeks
Secondary outcomes (3)
Serum nitric oxide levels
Serum levels of nitric oxide will be assessed.
Measured: 4 weeks
Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during dynamic plantarflexion exercise and handgrip combined with the cold pressor test
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff during dynamic plantarflexion exercise and handgrip combined with the cold pressor test.
Measured: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis during dynamic plantarflexion exercise and handgrip combined with the cold pressor test
The speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial applanation tonometry and a validated transfer function (AtCor Medical) during dynamic plantarflexion exercise and handgrip combined with the cold pressor test.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start7 Jul 2020
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Figueroa, Texas Tech University
- Investigators
- Arturo Figueroa, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600413
- Sponsor's protocol ID
- IRB2019-1197
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Citrulline Supplementation to Improve Vascular Function and Responsiveness at Rest and During Exercise in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05600413
- Acronym / sponsor ID
- IRB2019-1197
- Conditions
- Menopause
- Keywords
- Endothelial function, Blood pressure, Blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 31 Oct 2022 (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 objective of this project is to provide evidence that L-Citrulline (L-CIT) supplementation can improve vascular function at rest and in response to exercise in postmenopausal women.
Detailed description
L-CIT is a non-essential amino acid that is a precursor to L-arginine, the substrate used to produce an important vasodilatory molecule called nitric oxide. The purpose of this study is to identify the effects of 6 grams of L-CIT for 4 weeks on vascular function (endothelial function, blood flow, muscle oxygenation, and blood pressure) at rest and in response to different stressors (cold pressor test, isometric and dynamic exercise).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design
| Arm | Type | Receives |
|---|---|---|
| L-Citrulline | Experimental | Dietary Supplement: L-CitrullineL-Citrulline: 6 grams/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCrystalline Cellulose |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal (absence of menstruation > 1 year) between the ages of 50 - 79 years.
- Sedentary ( < 120 minutes of exercise/week)
- Resting systolic blood pressure < 150 mmHg and diastolic blood pressure < 90 mmHg
- Not participating as a subject in another study for at least 2 months prior to the study and for the duration of the study
- Willingness to abstain from food supplements 1 month prior to the start of the study and throughout the duration of the study
Key exclusion criteria (8 listed)
- Body mass index ≥ 40
- Currently taking more than one vasoactive drug for blood pressure control
- Cardiometabolic diseases or other chronic diseases
- Taking hormone replacement therapy 3 months prior to the study
- Current or prior use of tobacco products
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 |
|---|---|---|
| L-Citrulline4 weeks of L-Citrulline supplementation (6 grams/day) | Dietary supplement | L-Citrulline |
| Placebo4 weeks of Placebo (crystalline cellulose) | Dietary supplement | Placebo |
Primary outcome
Microvascular endothelial function
Time frame: 4 weeks
Endothelial function will be assessed via reactive hyperemic index using the EndoPAT device.
Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during metaboreflex activation
Time frame: 4 weeks
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff during isometric handgrip exercise and postexercise muscle ischemia.
Changes in aortic hemodynamics using pulse wave analysis during metaboreflex activation
Time frame: 4 weeks
The speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial applanation tonometry and a validated transfer function (AtCor Medical) during isometric handgrip exercise and postexercise muscle ischemia.
Blood flow during dynamic exercise
Time frame: 4 weeks
Blood flow will be measured using ultrasound in the superficial femoral and brachial artery during dynamic exercises superimposed with the cold pressor test.
Muscle oxygenation during dynamic exercise
Time frame: 4 weeks
Muscle oxygenation will be measured using near infrared spectroscopy during dynamic exercises superimposed with the cold pressor test.
3 secondary outcomes
Serum nitric oxide levels
Time frame: 4 weeks
Changes in brachial and aortic blood pressure responses via automated sphygmomanometry during dynamic plantarflexion exercise and handgrip combined with the cold pressor test
Time frame: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis during dynamic plantarflexion exercise and handgrip combined with the cold pressor test
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Arturo Figueroa principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Citrulline in people with Menopause, run by Texas Tech University 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular endothelial function (time frame: 4 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 31 Oct 2022.