HealthyNCT04090138
Setria Performance Blend Supplementation
A study testing Setria performance blend in people with Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The objective of this trial is to evaluate the effects of setria performance blend supplementation on endurance performance in healthy men. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Setria performance blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2019to 1 Nov 2020
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is an adult male between the ages of 20-30 years
- Participant is aerobically fit, as defined by a VO2max between 42-70 ml*kg/min (determined by the screening test)
- Participant is not obese (18.5 ≦ BMI < 30 kg/m²)
- Participant has provided written and dated informed consent to participate in the study
- Participant is willing and able to comply with the protocol
- Participant is apparently healthy and free from disease, as determined by a health history questionnaire
- Participant agrees to refrain from strenuous exercise and alcohol consumption within 24 hours of laboratory visits, and to refrain from caffeine consumption within twelve hours of visits
- Participant agrees to refrain from using antibacterial mouthwash, chewing gum, and brushing their teeth on the morning of laboratory visits
Who cannot join
- Participant has consistently used prescription drugs or ergogenic dietary supplements that may influence study outcomes within eight weeks prior to enrollment, or begins to do so during the study. Potential drugs and supplements include but are not limited to whey protein, creatine, beta-alanine, antihypertensive medications, or anabolic steroids
- Participant has gained or lost ≥10 lbs in the previous 2 months
- Participant is enrolled in a separate clinical trial involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement in the previous 2 months and during this study
- Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet that may influence study outcomes and during this study
- Participant has a known allergy or sensitivity to the placebo or active ingredients
- Participant consumes more than 3 alcoholic drinks per day
- Participant has used tobacco more than three days per week (on average) in the previous eight weeks
- Participant has used recreational drugs within the past month, or refuses to abstain from recreational drug use for the entirety of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory, Fetzer Hall Room 25
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effect of Setria Performance Blend on Endurance Performance
The objective of this trial is to evaluate the effects of setria performance blend supplementation on endurance performance in healthy men.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled crossover trial in healthy men. Subjects will take either a placebo or setria performance blend (L-citrulline + glutathione) for 8 days. At the day 8, subjects run on the treadmill to measure the time to exhaustion at 90%, 100%, and 110% of peak velocity. Arterial blood flow and blood vessel diameter (via ultrasound), blood analytes (plasma nitrate/nitrite, L-arginine, L-citrulline), subjective feelings of fatigue from a visual analog scale (VAS) and ratings of perceived exertion will be assessed. There is a minimum of a two week washout period in between trials/treatments. The same procedures are completed upon return visit.
- Conditions
- Healthy
- Being tested
- Setria performance blend, Placebo
- Keywords
- endurance performance, l-citrulline, glutathione
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setria performance blendDietary supplement
Also called l-citrulline + glutathione
Oral capsules
PlaceboDietary supplement
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Setria performance blend | Active comparator | l-citrulline + glutathione Receives: Dietary Supplement: Setria performance blend |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time to exhaustion (sec)
Measured from a treadmill run before and after 8 days of supplementation
Measured: 8 days
Change in Blood Flow (ml/min-1)
Measured from ultrasound before and after 8 days of supplementation
Measured: 8 days
Change in Vessel Diameter (mm)
Measured from ultrasound before and after 8 days of supplementation
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start30 Nov 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Kirin Holdings Company, Limited
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090138
- Sponsor's protocol ID
- 19-1375
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC and Kirin Holdings Co, Ltd
Publications
Cabre HE, Greenwalt CE, Gould LM, Smith-Ryan AE. The effects of L-Citrulline and Glutathione on Endurance performance in young adult trained males. J Int Soc Sports Nutr. 2023 Dec;20(1):2206386. doi: 10.1080/15502783.2023.2206386.
PubMed 37125500
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Setria Performance Blend on Endurance Performance
- ClinicalTrials.gov ID
- NCT04090138
- Acronym / sponsor ID
- 19-1375
- Conditions
- Healthy
- Keywords
- endurance performance, l-citrulline, glutathione
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Kirin Holdings Company, Limited
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 16 Sep 2019 (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 objective of this trial is to evaluate the effects of setria performance blend supplementation on endurance performance in healthy men.
Detailed description
This study is a randomized, double-blind, placebo-controlled crossover trial in healthy men. Subjects will take either a placebo or setria performance blend (L-citrulline + glutathione) for 8 days. At the day 8, subjects run on the treadmill to measure the time to exhaustion at 90%, 100%, and 110% of peak velocity. Arterial blood flow and blood vessel diameter (via ultrasound), blood analytes (plasma nitrate/nitrite, L-arginine, L-citrulline), subjective feelings of fatigue from a visual analog scale (VAS) and ratings of perceived exertion will be assessed. There is a minimum of a two week washout period in between trials/treatments. The same procedures are completed upon return visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Setria performance blend | Active comparator | Dietary Supplement: Setria performance blendl-citrulline + glutathione |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant is an adult male between the ages of 20-30 years
- Participant is aerobically fit, as defined by a VO2max between 42-70 ml*kg/min (determined by the screening test)
- Participant is not obese (18.5 ≦ BMI < 30 kg/m²)
- Participant has provided written and dated informed consent to participate in the study
- Participant is willing and able to comply with the protocol
Key exclusion criteria (8 listed)
- Participant has consistently used prescription drugs or ergogenic dietary supplements that may influence study outcomes within eight weeks prior to enrollment, or begins to do so during the study. Potential drugs and supplements include but are not limited to whey protein, creatine, beta-alanine, antihypertensive medications, or anabolic steroids
- Participant has gained or lost ≥10 lbs in the previous 2 months
- Participant is enrolled in a separate clinical trial involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement in the previous 2 months and during this study
- Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet that may influence study outcomes and during this study
- Participant has a known allergy or sensitivity to the placebo or active ingredients
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 |
|---|---|---|
| Setria performance blendAlso: l-citrulline + glutathioneOral capsules | Dietary supplement | Setria performance blend |
| PlaceboOral capsules | Dietary supplement | Placebo |
Primary outcome
Change in Time to exhaustion (sec)
Time frame: 8 days
Measured from a treadmill run before and after 8 days of supplementation
Change in Blood Flow (ml/min-1)
Time frame: 8 days
Measured from ultrasound before and after 8 days of supplementation
Change in Vessel Diameter (mm)
Time frame: 8 days
Measured from ultrasound before and after 8 days of supplementation
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 Apr 2021.
- Derived from this study: PubMed 37125500Cabre HE, Greenwalt CE, Gould LM, Smith-Ryan AE. The effects of L-Citrulline and Glutathione on Endurance performance in young adult trained males. J Int Soc Sports Nutr. 2023 Dec;20(1):2206386. doi: 10.1080/15502783.2023.2206386.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC and Kirin Holdings Co, Ltd
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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.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Setria performance blend in people with Healthy, run by University of North Carolina, Chapel Hill 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 8 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 Apr 2021. 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 Time to exhaustion (sec) (time frame: 8 days). The study lists 3 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 NCT04090138, which also lists 1 linked publication.
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 Apr 2021.