Metabolic SyndromeNCT06025357

Effects of L-citrulline Supplementation on Vascular Function in Metabolic Syndrome

A study testing L-Citrulline supplementation in people with Metabolic Syndrome and Menopause, run by Texas Tech University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this project is to provide evidence that L-Citrulline (CIT) supplementation can improve vascular function in the fasted and acute hyperglycemia conditions in middle-aged and older women with metabolic syndrome. Read more about this study

Who is it for?: Ages 45 to 79 years, women onlyHealthy volunteers can take part
Conditions the study is for: Metabolic Syndrome, Menopause
What is being tested?: L-Citrulline supplementation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2023to 1 Aug 2024
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 45 to 79 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must present at least 3 of the following 5 cardiometabolic risk factors
Waist circumference ≥88 cm
Fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%.
Blood pressure ≥130 mm Hg
Triglyceride ≥ 150 mg/dL
HDL <50 mg/dL

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The following are also inclusion criteria's:
Women aged 45-79 years old
Body mass index ≤ 39.9 kg/m2
Sedentary (defined as < 120 min/week of exercise)
Abstain from any dietary supplements with vascular effects for one month prior to the beginning of the study and until participation in study has terminated.

Who cannot join

< 45 and > 79 years of age
Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, biguanides, insulin, beta blockers, statins, verapamil)
Systolic blood pressure ≥ 160 mmHg
BMI > 40 kg/m2
Recent changes in medication (3 months)
Current smoking any tobacco use
Cardiovascular disease, diabetes (Type 1 or 2), and other metabolic or chronic diseases
More than 7 alcoholic drinks/week of consumption

Trial locations and contacts

1 site in 1 country.

United States1 site

TTU Kinesiology and Sport Management Building
Lubbock, Texas, 79409

Other trials in United States

About this study

Official title: Effects of L-Citrulline Supplementation on Vascular Function During Fasted and Acute Hyperglycemia in Middle-aged and Older Women With Metabolic Syndrome

Read the detailed description

Using a double-blind, randomized, placebo-controlled, and parallel design, middle-aged and older women with metabolic syndrome will be randomized into receiving either CIT supplementation (10g/day) or placebo (Microcrystalline Cellulose) for 4 weeks.

The first visit will be approximately 1hr and 30 minutes. The 2nd and 3rd visits will each be approximately 2hrs and 30 minutes, separated by 4 weeks in between each visit. During visits 2 and 3, vascular measurements will be assessed in the fasted state and 30, 60, and 90 minutes after acute glucose ingestion (75g).

Conditions: Metabolic Syndrome, Menopause
Being tested: L-Citrulline supplementation, Placebo
Keywords: Endothelial function, Aortic Hemodynamics, Blood pressure, Obesity, Hypertension
Medical subject headings: Metabolic Syndrome, Obesity, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L-Citrulline supplementationDietary supplement
4 weeks of L-Citrulline supplementation (10 grams/day).
PlaceboDietary supplement
4 weeks of microcrystalline Cellulose supplementation.

Study groups in NCT06025357
Study group	Role	What they receive
L-citrulline	Experimental	L-citrulline: 10 grams/day Receives: Dietary Supplement: L-Citrulline supplementation
Placebo	Experimental	Microcrystalline Cellulose Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Macrovascular Endothelial function in the fasted condition
Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Microvascular endothelial function in the fasted condition
Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) will assessed during reactive hyperemia at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Microvascular digital endothelial function in the fasted condition
Endothelial function will be measured using peripheral (finger) arterial tonometry (EndoPAT device) during reactive hyperemia at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Macrovascular Endothelial function during acute hyperglycemia
Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Microvascular forearm endothelial function during acute hyperglycemia
Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Central and peripheral arterial stiffness in the fasted condition
Arterial stiffness will be measured using central (carotid-femoral) and peripheral (femoral-ankle) PWV at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Central arterial stiffness during acute hyperglycemia
Arterial stiffness will be measured using central (carotid-femoral) PWV at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Blood pressure in the fasted condition
Brachial and aortic blood pressures will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Blood pressure during acute hyperglycemia
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured after an oral glucose ingestion at 30, 60, and 90 minutes at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Total peripheral resistance in the fasted condition.
Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Total peripheral resistance during acute hyperglycemia
Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Stroke volume in the fasted condition
Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Stroke volume during acute hyperglycemia
Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
24-hour ambulatory blood pressure monitoring
An ambulatory blood pressure cuff, measuring blood pressure for 24-hours will be obtained on two separate days at baseline and after 4 weeks of supplementation.
Measured: 4 weeks

Secondary outcomes (5)

Serum glucose and insulin levels.
Serum glucose and insulin levels will be tested at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Serum arginine levels
Serum L-Arginine levels will be tested at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Serum arginase levels
Serum arginase levels will be tested at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Serum Nitric Oxide levels
Serum nitric oxide levels will be tested at baseline and after 4 weeks of supplementation.
Measured: 4 weeks
Serum Endothelin-1 levels
Serum endothelin-1 levels will be tested at baseline and after 4 weeks of supplementation.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20231 Aug 2024

First posted6 Sep 2023
Study start1 Jan 2023
Primary completion1 May 2024
Study completion1 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies 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 Assignment Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06025357
Sponsor's protocol ID: IRB2022-362
Status last verified: Aug 2023
First submitted: 27 Jul 2023
Last updated: 15 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Figueroa A, Maharaj A, Kang Y, Dillon KN, Martinez MA, Morita M, Nogimura D, Fischer SM. Combined Citrulline and Glutathione Supplementation Improves Endothelial Function and Blood Pressure Reactivity in Postmenopausal Women. Nutrients. 2023 Mar 23;15(7):1557. doi: 10.3390/nu15071557.
PubMed 37049398
Maharaj A, Fischer SM, Dillon KN, Kang Y, Martinez MA, Figueroa A. Acute Citrulline Blunts Aortic Systolic Pressure during Exercise and Sympathoactivation in Hypertensive Postmenopausal Women. Med Sci Sports Exerc. 2022 May 1;54(5):761-768. doi: 10.1249/MSS.0000000000002848. Epub 2022 Jan 3.
PubMed 34974502
McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25.
PubMed 30412905
Figueroa A, Alvarez-Alvarado S, Ormsbee MJ, Madzima TA, Campbell JC, Wong A. Impact of L-citrulline supplementation and whole-body vibration training on arterial stiffness and leg muscle function in obese postmenopausal women with high blood pressure. Exp Gerontol. 2015 Mar;63:35-40. doi: 10.1016/j.exger.2015.01.046. Epub 2015 Jan 28.
PubMed 25636814
Maharaj A, Fischer SM, Dillon KN, Kang Y, Martinez MA, Figueroa A. Effects of L-Citrulline Supplementation on Endothelial Function and Blood Pressure in Hypertensive Postmenopausal Women. Nutrients. 2022 Oct 20;14(20):4396. doi: 10.3390/nu14204396.
PubMed 36297080

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of L-Citrulline Supplementation on Vascular Function During Fasted and Acute Hyperglycemia in Middle-aged and Older Women With Metabolic Syndrome
ClinicalTrials.gov ID: NCT06025357
Acronym / sponsor ID: IRB2022-362
Conditions: Metabolic Syndrome, Menopause
Keywords: Endothelial function, Aortic Hemodynamics, Blood pressure, Obesity, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Texas Tech UniversityUniversity, hospital or other
Study start: 1 Jan 2023 (actual)
Primary completion: 1 May 2024 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 6 Sep 2023 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Parallel Assignment Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design

Arm	Type	Receives
L-citrulline	Experimental	Dietary Supplement: L-Citrulline supplementationL-citrulline: 10 grams/day
Placebo	Experimental	Dietary Supplement: PlaceboMicrocrystalline Cellulose

Who may qualify

Ages: 45 to 79 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Must present at least 3 of the following 5 cardiometabolic risk factors
Waist circumference ≥88 cm
Fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%.
Blood pressure ≥130 mm Hg
Triglyceride ≥ 150 mg/dL

Key exclusion criteria (8 listed)

< 45 and > 79 years of age
Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, biguanides, insulin, beta blockers, statins, verapamil)
Systolic blood pressure ≥ 160 mmHg
BMI > 40 kg/m2
Recent changes in medication (3 months)

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-Citrulline supplementation4 weeks of L-Citrulline supplementation (10 grams/day).	Dietary supplement	L-citrulline
Placebo4 weeks of microcrystalline Cellulose supplementation.	Dietary supplement	Placebo

Primary outcome

Macrovascular Endothelial function in the fasted condition
Time frame: 4 weeks
Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at baseline and after 4 weeks of supplementation.
Microvascular endothelial function in the fasted condition
Time frame: 4 weeks
Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) will assessed during reactive hyperemia at baseline and after 4 weeks of supplementation.
Microvascular digital endothelial function in the fasted condition
Time frame: 4 weeks
Endothelial function will be measured using peripheral (finger) arterial tonometry (EndoPAT device) during reactive hyperemia at baseline and after 4 weeks of supplementation.
Macrovascular Endothelial function during acute hyperglycemia
Time frame: 4 weeks
Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Microvascular forearm endothelial function during acute hyperglycemia
Time frame: 4 weeks
Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Central and peripheral arterial stiffness in the fasted condition
Time frame: 4 weeks
Arterial stiffness will be measured using central (carotid-femoral) and peripheral (femoral-ankle) PWV at baseline and after 4 weeks of supplementation.
Central arterial stiffness during acute hyperglycemia
Time frame: 4 weeks
Arterial stiffness will be measured using central (carotid-femoral) PWV at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Blood pressure in the fasted condition
Time frame: 4 weeks
Brachial and aortic blood pressures will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured at baseline and after 4 weeks of supplementation.
Blood pressure during acute hyperglycemia
Time frame: 4 weeks
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured after an oral glucose ingestion at 30, 60, and 90 minutes at baseline and after 4 weeks of supplementation.
Total peripheral resistance in the fasted condition.
Time frame: 4 weeks
Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation.
Total peripheral resistance during acute hyperglycemia
Time frame: 4 weeks
Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Stroke volume in the fasted condition
Time frame: 4 weeks
Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation.
Stroke volume during acute hyperglycemia
Time frame: 4 weeks
Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
24-hour ambulatory blood pressure monitoring
Time frame: 4 weeks
An ambulatory blood pressure cuff, measuring blood pressure for 24-hours will be obtained on two separate days at baseline and after 4 weeks of supplementation.

5 secondary outcomes

Serum glucose and insulin levels.
Time frame: 4 weeks
Serum arginine levels
Time frame: 4 weeks
Serum arginase levels
Time frame: 4 weeks
Serum Nitric Oxide levels
Time frame: 4 weeks
Serum Endothelin-1 levels
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 15 May 2025.
Background: PubMed 37049398Figueroa A, Maharaj A, Kang Y, Dillon KN, Martinez MA, Morita M, Nogimura D, Fischer SM. Combined Citrulline and Glutathione Supplementation Improves Endothelial Function and Blood Pressure Reactivity in Postmenopausal Women. Nutrients. 2023 Mar 23;15(7):1557. doi: 10.3390/nu15071557.
Background: PubMed 34974502Maharaj A, Fischer SM, Dillon KN, Kang Y, Martinez MA, Figueroa A. Acute Citrulline Blunts Aortic Systolic Pressure during Exercise and Sympathoactivation in Hypertensive Postmenopausal Women. Med Sci Sports Exerc. 2022 May 1;54(5):761-768. doi: 10.1249/MSS.0000000000002848. Epub 2022 Jan 3.
Background: PubMed 30412905McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25.
Background: PubMed 25636814Figueroa A, Alvarez-Alvarado S, Ormsbee MJ, Madzima TA, Campbell JC, Wong A. Impact of L-citrulline supplementation and whole-body vibration training on arterial stiffness and leg muscle function in obese postmenopausal women with high blood pressure. Exp Gerontol. 2015 Mar;63:35-40. doi: 10.1016/j.exger.2015.01.046. Epub 2015 Jan 28.
Results publication: PubMed 36297080Maharaj A, Fischer SM, Dillon KN, Kang Y, Martinez MA, Figueroa A. Effects of L-Citrulline Supplementation on Endothelial Function and Blood Pressure in Hypertensive Postmenopausal Women. Nutrients. 2022 Oct 20;14(20):4396. doi: 10.3390/nu14204396.
Individual participant dataSharing planned: No

Related trials for Metabolic Syndrome

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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 supplementation in people with Metabolic Syndrome 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 11 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 15 May 2025. 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. 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?

Macrovascular Endothelial function in the fasted condition (time frame: 4 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06025357, which also lists 5 linked publications.

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 15 May 2025.