Clinical trial NCT04090138: Setria Performance Blend Supplementation
Official title: The Effect of Setria Performance Blend on Endurance Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: endurance performance, l-citrulline, glutathione
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Kirin Holdings Company, Limited
First posted: 2019-09-16
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Time to exhaustion (sec)
timeFrame: 8 days
measure: Change in Blood Flow (ml/min-1)
timeFrame: 8 days
measure: Change in Vessel Diameter (mm)
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Physiology Laboratory, Fetzer Hall Room 25
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: