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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks of each intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I have not had a menstrual period for at least one year.

Select...

I am between 50 and 70 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks of each intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

Side effects data

From 2021 Phase 2 trial • 65 Patients • NCT04570384

Infusion Site Reaction

Deep Vein Thrombosis

Dyspnoea

Clostridium Difficile Infection

Urinary Tract Infection

Staphylococcal Sepsis; Alpha Haemolytic Streptococcal Infection

Pain In Extremity

Skin Wound

Acute kidney injury

Cardiac failure; metabolic acidosis

Chest pain; Dyspnoea; COVID-19

Intracranial hemorrhage

Acute Myocardial Infarction

Status epilepticus

Syncope

Enterococcal Infection

Enterococcus Test Positive

Epistaxis

Hypoglycaemia

Hypoxia

Tachycardia

Ventricular Extrasystoles

100%

80%

60%

40%

20%

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

~340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Texas Tech UniversityLead Sponsor

81 Previous Clinical Trials

9,145 Total Patients Enrolled

Arturo FigueroaPrincipal InvestigatorTexas Tech University

5 Previous Clinical Trials

155 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to take part in this medical experiment?

"To take part in this research, potential participants should have entered menopause and be aged between 50 to 70. The total number of volunteers needed is 19 individuals."

Answered by AI

Are individuals still able to enroll in this research trial?

"Affirmative. Records on clinicaltrials.gov point to this medical trial being in the process of recruiting candidates; it was initially posted on July 20th, 2023 and updated most recently on August 29th, 2023. This study is looking for 19 patient participants from one site."

Answered by AI

Is participation in this trial exclusive to individuals under 35 or can adults over that age join?

"The requirements for participation in this medical trial mandate that applicants are aged 50 to 70. In contrast, there are 54 studies available for people younger than 18 and 706 clinical trials targeting those 65 years or older."

Answered by AI

How many participants can this trial accommodate?

"Indeed, according to clinicaltrials.gov this experiment is currently enrolling volunteers. It was first made available on July 20th 2023 and the latest amendment occurred on August 29th of the same year. The study requires 19 individuals to be recruited from a single clinic."

Answered by AI

What is the overarching aim of this experiment?

"This two-week trial monitors the microvascular endothelial function at rest. Secondary objectives and measurements taken include aortic hemodynamics, radial applanation tonometry, stroke volume via impedance cardiography, and heart rate also using impedance cardiography."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

2 Weeks of Citrulline Supplementation on Arterial Function in Postmenopausal Women With Elevated Blood Pressure or Hypertension

Arturo Figueroa 2023. "2 Weeks of Citrulline Supplementation on Arterial Function in Postmenopausal Women With Elevated Blood Pressure or Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06025383.

All > Menopause