MenopauseNCT04672447
Effect of 4 Weeks of Citrulline and Glutathione Supplementation on Arterial Function
A study testing L-Citrulline and Glutathione in people with Menopause and Cardiovascular Risk Factor, run by Texas Tech University at 1 site in United States.
Trial summary
Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on the arterial function of 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, Cardiovascular Risk Factor
- What is being tested?
- L-Citrulline and Glutathione
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 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
- Generally healthy, postmenopausal women (defined as the absence of menstruation for at least 1 year).
- Between the ages of 50-79 years.
- Body mass index of 18.5 - 34.9 kg/m2.
- Brachial systolic blood pressure < 150 mmHg, and diastolic blood pressure < 90 mmHg.
- Sedentary (defined as < 120 min/week of exercise).
- Be willing and able to comfortably abstain from any of food supplements for the period of time beginning 1 month prior to the study to the time of the termination of the study.
- Not participating as a subject in another study for at least 2 months prior to the study and for the duration of this study.
Who cannot join
- Current or prior use of tobacco products, e-cigarettes or other inhaled substance.
- Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, but not limited to those.)
- Taking hormone replacement therapy during the 3 months before the study.
- More than a moderate intake of alcohol (>7 drink per week).
- Cardiovascular diseases, diabetes and other metabolic or chronic diseases.
- Musculoskeletal disorders that will prevent exercise performance.
- Currently taking more than one vasoactive drug for blood pressure control.
- Subject having no more than one drug for prevention, which does not affect variables, may be included, but will be diagnosed as not having a disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
TTU Kinesiology and Sport Management Building
Lubbock, Texas, 79409
About this study
Official title: Effects of 4 Weeks Supplementation With L-Citrulline and Glutathione on Arterial Function and Cardiovascular Responses in Postmenopausal Healthy Women: A Pilot Study
Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on the arterial function of postmenopausal women.
Read the detailed description
L-Citrulline is a non-protein amino acid and an efficient precursor of L-arginine, the substrate for endothelial nitric oxide synthesis. Glutathione is a tripeptide with antioxidant effects. Postmenopausal women will ingest 6g/d of L-Citrulline or 2g of L-Citrulline plus 200mg/d of glutathione or placebo (maltodextrin) for 4 weeks with vascular function testing prior to and after the intervention.
- Conditions
- Menopause, Cardiovascular Risk Factor
- Being tested
- L-Citrulline, Placebo, Glutathione
- Keywords
- Endothelial Function, Aortic Hemodynamics, Pressure Wave Reflection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CitrullineDietary supplement
Four weeks of oral L-Citrulline (2 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
L-CitrullineDietary supplement
Four weeks of oral L-Citrulline (6 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
PlaceboDietary supplement
Four weeks of oral placebo (6 grams/day maltodextrin) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
GlutathioneDietary supplement
Four weeks of Glutathione (200mg/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
| Study group | Role | What they receive |
|---|---|---|
| L-Citrulline + Glutathione | Experimental | Citrulline: 2 grams/day, Glutathione: 200mg/day for 4 weeks Receives: Dietary Supplement: L-Citrulline; Dietary Supplement: Glutathione |
| L-Citrulline | Experimental | Citrulline: 6 grams/day Receives: Dietary Supplement: L-Citrulline |
| Placebo | Placebo comparator | Maltodextrin: 6 grams/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function
Endothelial function will be measured before and after the intervention using brachial artery flow mediated dilation at rest, blood flow measured in the brachial artery during handgrip exercise, and blood flow in the common femoral artery during passive leg movement. All measurements performed using doppler ultrasound.
Measured: 4 weeks
Change in arterial stiffness
Arterial stiffness will be assessed through measurement of pulse-wave velocity of the carotid-femoral, carotid radial, carotid-ankle and femoral ankle arterial segments before and after the 4 week interventions.
Measured: 4 weeks
Blood pressure control during the cold pressor test
Blood pressure will be measured during the cold pressor test before and after the 4 weeks.
Measured: 4 weeks
L-Arginine bioavailability
Plasma levels of arginine will be measured before and after the 4 week intervention.
Measured: 4 weeks
Secondary outcomes (7)
cardiovascular hemodynamics using pulse wave analysis during the cold pressor test
arterial tonometry will be measured during the cold pressor test before and after the 4 week intervention.
Measured: 4 weeks
body composition
We will determine whether L-citrulline + glutathione changes body composition more than L-citrulline or placebo.
Measured: 4 weeks
Muscle Strength
Leg Extension strength will be measured before and after the 4 weeks.
Measured: 4 weeks
L-Citrulline levels
Plasma levels of L-Citrulline will be measured before and after the 4 weeks.
Measured: 4 weeks
Glutathione peroxidase levels
Blood levels of glutathione peroxidase will be measured before and after the 4 weeks
Measured: 4 weeks
Malondialdehyde
blood levels of malondialdehyde will be measured before and after the 4 weeks
Measured: 4 weeks
L-Ornithine levels
plasma levels of L-ornithine will be measured before and after the 4 weeks
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 posted17 Dec 2020
- Study start1 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
- Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Hakko Bio Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672447
- Sponsor's protocol ID
- 20-0152
- Status last verified
- Oct 2022
- First submitted
- 10 Dec 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 4 Weeks Supplementation With L-Citrulline and Glutathione on Arterial Function and Cardiovascular Responses in Postmenopausal Healthy Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT04672447
- Acronym / sponsor ID
- 20-0152
- Conditions
- Menopause, Cardiovascular Risk Factor
- Keywords
- Endothelial Function, Aortic Hemodynamics, Pressure Wave Reflection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Kyowa Hakko Bio Co., Ltd.
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 17 Dec 2020 (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.
Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on the arterial function of postmenopausal women.
Detailed description
L-Citrulline is a non-protein amino acid and an efficient precursor of L-arginine, the substrate for endothelial nitric oxide synthesis. Glutathione is a tripeptide with antioxidant effects. Postmenopausal women will ingest 6g/d of L-Citrulline or 2g of L-Citrulline plus 200mg/d of glutathione or placebo (maltodextrin) for 4 weeks with vascular function testing prior to and after the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
| Arm | Type | Receives |
|---|---|---|
| L-Citrulline + Glutathione | Experimental | Dietary Supplement: L-Citrulline, Dietary Supplement: GlutathioneCitrulline: 2 grams/day, Glutathione: 200mg/day for 4 weeks |
| L-Citrulline | Experimental | Dietary Supplement: L-CitrullineCitrulline: 6 grams/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin: 6 grams/day |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Generally healthy, postmenopausal women (defined as the absence of menstruation for at least 1 year).
- Between the ages of 50-79 years.
- Body mass index of 18.5 - 34.9 kg/m2.
- Brachial systolic blood pressure < 150 mmHg, and diastolic blood pressure < 90 mmHg.
- Sedentary (defined as < 120 min/week of exercise).
Key exclusion criteria (8 listed)
- Current or prior use of tobacco products, e-cigarettes or other inhaled substance.
- Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, but not limited to those.)
- Taking hormone replacement therapy during the 3 months before the study.
- More than a moderate intake of alcohol (>7 drink per week).
- Cardiovascular diseases, diabetes and other metabolic or chronic diseases.
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-CitrullineFour weeks of oral L-Citrulline (2 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night. | Dietary supplement | L-Citrulline + Glutathione |
| L-CitrullineFour weeks of oral L-Citrulline (6 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night. | Dietary supplement | L-Citrulline |
| PlaceboFour weeks of oral placebo (6 grams/day maltodextrin) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night. | Dietary supplement | Placebo |
| GlutathioneFour weeks of Glutathione (200mg/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night. | Dietary supplement | L-Citrulline + Glutathione |
Primary outcome
Change in endothelial function
Time frame: 4 weeks
Endothelial function will be measured before and after the intervention using brachial artery flow mediated dilation at rest, blood flow measured in the brachial artery during handgrip exercise, and blood flow in the common femoral artery during passive leg movement. All measurements performed using doppler ultrasound.
Change in arterial stiffness
Time frame: 4 weeks
Arterial stiffness will be assessed through measurement of pulse-wave velocity of the carotid-femoral, carotid radial, carotid-ankle and femoral ankle arterial segments before and after the 4 week interventions.
Blood pressure control during the cold pressor test
Time frame: 4 weeks
Blood pressure will be measured during the cold pressor test before and after the 4 weeks.
L-Arginine bioavailability
Time frame: 4 weeks
Plasma levels of arginine will be measured before and after the 4 week intervention.
7 secondary outcomes
cardiovascular hemodynamics using pulse wave analysis during the cold pressor test
Time frame: 4 weeks
body composition
Time frame: 4 weeks
Muscle Strength
Time frame: 4 weeks
L-Citrulline levels
Time frame: 4 weeks
Glutathione peroxidase levels
Time frame: 4 weeks
Malondialdehyde
Time frame: 4 weeks
L-Ornithine 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 20 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Glutathione in people with Menopause and Cardiovascular Risk Factor, 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 7 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 20 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?
Change in endothelial function (time frame: 4 weeks). The study lists 4 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 20 Oct 2022.