HypertensionNCT05227781
8 Weeks of L-CIT Supplementation and LIRET on Vascular Function in Hypertensive Postmenopausal Women
A study testing L-Citrulline in people with Hypertension and Menopause, run by Texas Tech University at 1 site in United States.
Trial summary
The overall objective of this project is to bring forth evidence that L-Citrulline (L-CIT) supplementation and low intensity resistance exercise training (LIRET) alone and combined will improve vascular function and muscle fitness (mass, strength, and exercise performance) in postmenopausal women with hypertension. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Menopause
- What is being tested?
- L-Citrulline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2018to 10 Jan 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 50-75 years
- Resting systolic BP 120-159 mmHg
- Sedentary (< 60 min of exercise/week)
- Body mass index of 18.5-39.9 kg/m2)
- Fasting glucose < 126 mg/dL
- HbA1c < 6.4%.
Who cannot join
- Body mass index ≥ 40 or < 18.5 kg/m2
- Diagnosed with type 1 or 2 diabetes mellitus
- Cardiovascular diseases
- Systolic blood pressure > 170 mmHg or on more than two anti-hypertensive medication
- Other chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
- Individuals incorporated in a weight loss program and aerobic or resistance training program
- Heavy smokers (> 20 cigarettes per day)
- Heavy drinkers (> 12 alcoholic drinks per week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 8 Weeks of L-Citrulline Supplementation to Improve Low-intensity Resistance Exercise Training Vascular Adaptations in Postmenopausal Women With Hypertension
The overall objective of this project is to bring forth evidence that L-Citrulline (L-CIT) supplementation and low intensity resistance exercise training (LIRET) alone and combined will improve vascular function and muscle fitness (mass, strength, and exercise performance) in postmenopausal women with hypertension. The investigators' central hypothesis is that adjuvant L-CIT supplementation may synergistically enhance vascular (arterial stiffness, BP, muscle oxygenation, blood flow) and muscular (strength, exercise performance) responses to LIRET in postmenopausal women with hypertension by improving endothelial vasodilatory function.
Read the detailed description
Individuals who are on medications will refrain from use the morning of all laboratory visits. Participants will be asked to bring medications with them, and will be allowed to ingest it after the vascular measurements have been obtained.
There will be a total of 7 laboratory visits. The 1st visit will be approximately 1 hr and 45 minutes. The 2nd and 3rd visit will be approximately 2 hrs. The 4th and 6th visit will total about 2 hrs and 15 minutes and finally, the 5th and 7th visit will total about 1hr and 15 minutes. This means the total participant time for laboratory visits will be approximately 12 hours. In addition to this, the second 4 weeks of the 8 week study period will involve coming to the Kinesiology and Sport Management building at Texas Tech University main campus 3 times per week to perform the low-intensity resistance training intervention. These visits should last no more than 30-45 minutes.
The first 3 visits will be separated by 48-72 hrs. Visits 3 and 4 will be separated by 4 weeks (first 4 weeks of LCIT or Placebo supplementation). Visits 4 and 5 will be separated by 48-72 hours. Visits 5 and 6 will again be separated by 4 weeks (Second 4 weeks of LCIT or Placebo supplementation with the addition of Low-intensity resistance exercise in both groups).
Approximately 12 hours total for each of the 7 laboratory visits, as well as 30-45 minutes 3 times per week during the last 4 weeks of the 8 week study.
Using a parallel placebo-controlled design, postmenopausal women with elevated blood pressure or hypertension will be randomized to receive L-CIT supplementation (10g/day) alone for 4 weeks, followed by 4 weeks of L-CIT supplementation in combination with low-intensity resistance training or placebo (maltodextrin) alone for 4 weeks, followed by 4 weeks of placebo in combination with low-intensity resistance training.
Differences between conditions (Citrulline vs Placebo) will be analyzed with independent samples t-test. Two-way ANOVA with repeated measures with Bonferroni adjustments will be used to analyze group (CIT vs. PL) by time (baseline, post-supplementation only, supplement + low-intensity resistance exercise training) interactions between the outcome variables. If group-by-time interactions are detected, post-hoc comparisons will be performed via paired or independent t-tests.
- Conditions
- Hypertension, Menopause
- Being tested
- L-Citrulline, Placebo
- Keywords
- Endothelial Function, Arterial Stiffness, Muscle Function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CitrullineDietary supplement
8 weeks of L-Citrulline supplementation (10 grams/day)
PlaceboDietary supplement
8 weeks of Placebo (maltodextrin; 10 grams/day)
| Study group | Role | What they receive |
|---|---|---|
| L-Citrulline | Experimental | L-Citrulline: 10 grams/day Receives: Dietary Supplement: L-Citrulline |
| Placebo | Placebo comparator | Maltodextrin: 10 grams/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline only)
Endothelial function will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone using brachial artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in endothelial function via superficial femoral artery flow-mediated dilation (effects of L-Citrulline only)
Endothelial function will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone using superficial femoral artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, endothelial function will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs using brachial artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in endothelial function via superficial femoral artery flow-mediated dilation (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, endothelial function will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs using superficial femoral artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in arm exercise blood flow (effects of L-Citrulline only)
Blood flow will be measured in the brachial artery during low intensity arm exercise. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in leg exercise blood flow (effects of L-Citrulline only)
Blood flow will be measured in the superficial femoral arteries during low intensity leg exercise. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in arm exercise blood flow (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, blood flow will be measured in the brachial artery during low intensity arm exercise. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Changes in leg exercise blood flow (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, blood flow will be measured in the superficial femoral artery during low intensity leg exercise. All measurements will be performed using Doppler ultrasound.
Measured: 4 weeks
Secondary outcomes (18)
Changes in arterial stiffness via arm, leg, and aortic pulse wave velocity (effects of L-Citrulline only)
Arterial stiffness will be assessed using pulse wave velocity of the arm (carotid-radial), leg (femoral-ankle), and aorta (carotid-femoral) at baseline and after 4 weeks of L-Citrulline supplementation alone using applanation tonometry.
Measured: 4 weeks
Changes in arterial stiffness via arm, leg, and aortic pulse wave velocity (effects of L-Citrulline combined with low-intensity resistance exercise training)
Arterial stiffness will be assessed using pulse wave velocity of the arms (carotid-radial), legs (femoral-ankle), and aorta (carotid femoral) using applanation tonometry after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis (effects of L-Citrulline only)
The speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial artery pulses and a validated transfer function (AtCor Medical) at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis (effects of L-Citrulline combined with low-intensity resistance exercise training)
The speed and reflection pressures, both representing aortic hemodynamic parameters, will be assessed using radial artery pulses and a validated transfer function (AtCor Medical) after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Changes in brachial and aortic blood pressure via automated sphygmomanometry (effects of L-Citrulline only)
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Changes in brachial and aortic blood pressure via automated sphygmomanometry (effects of L-Citrulline combined with low-intensity resistance exercise training)
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an arm cuff after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Changes in muscle strength (effects of L-Citrulline only)
Handgrip and leg strength (leg press, leg extension, leg flexion, calf raises) will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Changes in muscle strength (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, handgrip and leg strength (leg press, leg extension, leg flexion, calf raises) will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs. These 4 exercises are to be of focus during the training sessions (3 days/week, 12 total training sessions).
Measured: 4 weeks
Quantification of L-Arginine (effects of L-Citrulline only)
Serum levels of L-Arginine (nmol/ul) will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Quantification of Arginase (effects of L-Citrulline only)
Serum levels ofarginase (pg/mL) will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Quantification of nitric oxide (effects of L-Citrulline only)
Serum levels ofnitric oxide (umol/L) will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Quantification of Endothelin-1 (effects of L-Citrulline only)
Serum levels of endothelin-1 (pg/mL) will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Quantification of L-Ornithine (effects of L-Citrulline only)
Serum levels of L-Ornithine (pmol/ul) will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone.
Measured: 4 weeks
Quantification of L-Arginine (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, serum levels of L-Arginine (nmol/ul) will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Quantification of arginase (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, serum levels of arginase (pg/mL) will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Quantification of nitric oxide (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, serum levels of nitric oxide (umol/L) will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Quantification of endothelin-1 (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, serum levels of endothelin-1 (pg/mL) will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
Measured: 4 weeks
Quantification of L-Ornithine (effects of L-Citrulline combined with low-intensity resistance exercise training)
After the 4-week assessment, serum levels of L-Ornithine (pmol/ul) will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs.
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 posted7 Feb 2022
- Study start24 May 2018
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double-blind (subject, investigator), randomized, parallel, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 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
- NCT05227781
- Sponsor's protocol ID
- IRB2018-463
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants are to be de-identified. Only anthropometric information and data from the outcome variables will be analyzed. All data will be condensed into an SPSS file, which will then be given to Doctoral Students for analysis. This file will be transferred between hard drives, not sent via email. This is done to ensure that all data remains confidential.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 8 Weeks of L-Citrulline Supplementation to Improve Low-intensity Resistance Exercise Training Vascular Adaptations in Postmenopausal Women With Hypertension
- ClinicalTrials.gov ID
- NCT05227781
- Acronym / sponsor ID
- IRB2018-463
- Conditions
- Hypertension, Menopause
- Keywords
- Endothelial Function, Arterial Stiffness, Muscle Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 7 Feb 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 overall objective of this project is to bring forth evidence that L-Citrulline (L-CIT) supplementation and low intensity resistance exercise training (LIRET) alone and combined will improve vascular function and muscle fitness (mass, strength, and exercise performance) in postmenopausal women with hypertension. The investigators' central hypothesis is that adjuvant L-CIT supplementation may synergistically enhance vascular (arterial stiffness, BP, muscle oxygenation, blood flow) and muscular (strength, exercise performance) responses to LIRET in postmenopausal women with hypertension by improving endothelial vasodilatory function.
Detailed description
Individuals who are on medications will refrain from use the morning of all laboratory visits. Participants will be asked to bring medications with them, and will be allowed to ingest it after the vascular measurements have been obtained.
There will be a total of 7 laboratory visits. The 1st visit will be approximately 1 hr and 45 minutes. The 2nd and 3rd visit will be approximately 2 hrs. The 4th and 6th visit will total about 2 hrs and 15 minutes and finally, the 5th and 7th visit will total about 1hr and 15 minutes. This means the total participant time for laboratory visits will be approximately 12 hours. In addition to this, the second 4 weeks of the 8 week study period will involve coming to the Kinesiology and Sport Management building at Texas Tech University main campus 3 times per week to perform the low-intensity resistance training intervention. These visits should last no more than 30-45 minutes.
The first 3 visits will be separated by 48-72 hrs. Visits 3 and 4 will be separated by 4 weeks (first 4 weeks of LCIT or Placebo supplementation). Visits 4 and 5 will be separated by 48-72 hours. Visits 5 and 6 will again be separated by 4 weeks (Second 4 weeks of LCIT or Placebo supplementation with the addition of Low-intensity resistance exercise in both groups).
Approximately 12 hours total for each of the 7 laboratory visits, as well as 30-45 minutes 3 times per week during the last 4 weeks of the 8 week study.
Using a parallel placebo-controlled design, postmenopausal women with elevated blood pressure or hypertension will be randomized to receive L-CIT supplementation (10g/day) alone for 4 weeks, followed by 4 weeks of L-CIT supplementation in combination with low-intensity resistance training or placebo (maltodextrin) alone for 4 weeks, followed by 4 weeks of placebo in combination with low-intensity resistance training.
Differences between conditions (Citrulline vs Placebo) will be analyzed with independent samples t-test. Two-way ANOVA with repeated measures with Bonferroni adjustments will be used to analyze group (CIT vs. PL) by time (baseline, post-supplementation only, supplement + low-intensity resistance exercise training) interactions between the outcome variables. If group-by-time interactions are detected, post-hoc comparisons will be performed via paired or independent t-tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind (subject, investigator), randomized, parallel, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| L-Citrulline | Experimental | Dietary Supplement: L-CitrullineL-Citrulline: 10 grams/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin: 10 grams/day |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 50-75 years
- Resting systolic BP 120-159 mmHg
- Sedentary (< 60 min of exercise/week)
- Body mass index of 18.5-39.9 kg/m2)
- Fasting glucose < 126 mg/dL
Key exclusion criteria (8 listed)
- Body mass index ≥ 40 or < 18.5 kg/m2
- Diagnosed with type 1 or 2 diabetes mellitus
- Cardiovascular diseases
- Systolic blood pressure > 170 mmHg or on more than two anti-hypertensive medication
- Other chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
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-Citrulline8 weeks of L-Citrulline supplementation (10 grams/day) | Dietary supplement | L-Citrulline |
| Placebo8 weeks of Placebo (maltodextrin; 10 grams/day) | Dietary supplement | Placebo |
Primary outcome
Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline only)
Time frame: 4 weeks
Endothelial function will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone using brachial artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Changes in endothelial function via superficial femoral artery flow-mediated dilation (effects of L-Citrulline only)
Time frame: 4 weeks
Endothelial function will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone using superficial femoral artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
After the 4-week assessment, endothelial function will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs using brachial artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Changes in endothelial function via superficial femoral artery flow-mediated dilation (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
After the 4-week assessment, endothelial function will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs using superficial femoral artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.
Changes in arm exercise blood flow (effects of L-Citrulline only)
Time frame: 4 weeks
Blood flow will be measured in the brachial artery during low intensity arm exercise. All measurements will be performed using Doppler ultrasound.
Changes in leg exercise blood flow (effects of L-Citrulline only)
Time frame: 4 weeks
Blood flow will be measured in the superficial femoral arteries during low intensity leg exercise. All measurements will be performed using Doppler ultrasound.
Changes in arm exercise blood flow (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
After the 4-week assessment, blood flow will be measured in the brachial artery during low intensity arm exercise. All measurements will be performed using Doppler ultrasound.
Changes in leg exercise blood flow (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
After the 4-week assessment, blood flow will be measured in the superficial femoral artery during low intensity leg exercise. All measurements will be performed using Doppler ultrasound.
18 secondary outcomes
Changes in arterial stiffness via arm, leg, and aortic pulse wave velocity (effects of L-Citrulline only)
Time frame: 4 weeks
Changes in arterial stiffness via arm, leg, and aortic pulse wave velocity (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis (effects of L-Citrulline only)
Time frame: 4 weeks
Changes in aortic hemodynamics using pulse wave analysis (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Changes in brachial and aortic blood pressure via automated sphygmomanometry (effects of L-Citrulline only)
Time frame: 4 weeks
Changes in brachial and aortic blood pressure via automated sphygmomanometry (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Changes in muscle strength (effects of L-Citrulline only)
Time frame: 4 weeks
Changes in muscle strength (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Quantification of L-Arginine (effects of L-Citrulline only)
Time frame: 4 weeks
Quantification of Arginase (effects of L-Citrulline only)
Time frame: 4 weeks
Quantification of nitric oxide (effects of L-Citrulline only)
Time frame: 4 weeks
Quantification of Endothelin-1 (effects of L-Citrulline only)
Time frame: 4 weeks
Quantification of L-Ornithine (effects of L-Citrulline only)
Time frame: 4 weeks
Quantification of L-Arginine (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Quantification of arginase (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Quantification of nitric oxide (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Quantification of endothelin-1 (effects of L-Citrulline combined with low-intensity resistance exercise training)
Time frame: 4 weeks
Quantification of L-Ornithine (effects of L-Citrulline combined with low-intensity resistance exercise training)
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 7 Feb 2022.
- Individual participant dataSharing planned: No. All participants are to be de-identified. Only anthropometric information and data from the outcome variables will be analyzed. All data will be condensed into an SPSS file, which will then be given to Doctoral Students for analysis. This file will be transferred between hard drives, not sent via email. This is done to ensure that all data remains confidential.
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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 Hypertension and 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 6 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 7 Feb 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?
Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline only) (time frame: 4 weeks). The study lists 8 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 7 Feb 2022.