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Citrulline Supplementation for High Blood Pressure in Postmenopausal Women
N/A
Recruiting
Led By Arturo Figueroa
Research Sponsored by Texas Tech University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal women (defined as the absence of menstruation for at least 1 year)
Between the ages of 50 - 70 years
Must not have
Taking more than two antihypertensive medications
Participants on beta-blockers or other vasodilatory supplements (nitrates)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks of each intervention
Summary
This trial studies how L-Citrulline supplements can improve vascular function in postmenopausal women with high blood pressure.
Who is the study for?
This trial is for postmenopausal women aged 50-70 with a BMI of 25-39.9, who exercise less than two hours per week and have high blood pressure (120-150 mmHg). They must not be on certain medications or have had recent changes in their hypertension treatment, nor should they have cardiovascular diseases, diabetes, musculoskeletal disorders, cancer, or habits like smoking and heavy drinking.
What is being tested?
The study tests if L-Citrulline supplements can improve blood vessel function at rest and during handgrip exercises in postmenopausal women with high blood pressure. Participants will either receive the supplement or a placebo to compare effects.
What are the potential side effects?
L-Citrulline may cause mild side effects such as stomach discomfort or indigestion. However, since it's generally considered safe at recommended doses for short-term use, significant side effects are uncommon.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had a menstrual period for at least one year.
Select...
I am between 50 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on more than two medications for high blood pressure.
Select...
I am taking beta-blockers or supplements that widen my blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks of each intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks of each intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brachial artery blood flow at rest and during rhythmic handgrip exercise with and without lower-body negative pressure
Forearm muscle oxygenation at rest and during rhythmic handgrip exercise with and without lower-body negative pressure
Macrovascular endothelial function at rest
+1 moreSecondary study objectives
Aortic hemodynamics at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Beat-to-beat blood pressure at rest and during rhythmic handgrip exercise with and without lower-body negative pressure
Central and peripheral arterial stiffness at rest
+8 moreSide effects data
From 2021 Phase 2 trial • 65 Patients • NCT045703849%
Infusion Site Reaction
6%
Deep Vein Thrombosis
6%
Dyspnoea
6%
Clostridium Difficile Infection
6%
Urinary Tract Infection
3%
Staphylococcal Sepsis; Alpha Haemolytic Streptococcal Infection
3%
Pain In Extremity
3%
Skin Wound
3%
Acute kidney injury
3%
Cardiac failure; metabolic acidosis
3%
Chest pain; Dyspnoea; COVID-19
3%
Intracranial hemorrhage
3%
Acute Myocardial Infarction
3%
Status epilepticus
3%
Syncope
3%
Enterococcal Infection
3%
Enterococcus Test Positive
3%
Epistaxis
3%
Hypoglycaemia
3%
Hypoxia
3%
Tachycardia
3%
Ventricular Extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Arm
IV L-Citrulline (Turnobi) Arm
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-CitrullineExperimental Treatment1 Intervention
L-Citrulline: 6 grams/day divided in 2 equal doses
Group II: PlaceboPlacebo Group1 Intervention
Microcrystalline cellulose: 8 capsules/day divided into 2 equal doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-Citrulline
2023
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Texas Tech UniversityLead Sponsor
82 Previous Clinical Trials
9,260 Total Patients Enrolled
Arturo FigueroaPrincipal InvestigatorTexas Tech University
5 Previous Clinical Trials
155 Total Patients Enrolled