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Completed

NCT Number: NCT04090138

Setria Performance Blend Supplementation

The objective of this trial is to evaluate the effects of setria performance blend supplementation on endurance performance in healthy men.

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Key information

Conditions

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory, Fetzer Hall Room 25

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Setria performance blend

Dietary Supplement

Oral capsules

Other names: l-citrulline + glutathione

Placebo

Dietary Supplement

Oral capsules

Primary outcomes

  1. Change in Time to exhaustion (sec)

    Time frame: 8 days

    Measured from a treadmill run before and after 8 days of supplementation

  2. Change in Blood Flow (ml/min-1)

    Time frame: 8 days

    Measured from ultrasound before and after 8 days of supplementation

  3. Change in Vessel Diameter (mm)

    Time frame: 8 days

    Measured from ultrasound before and after 8 days of supplementation

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Kirin Holdings Company, Limited

Registry information

Official study title

The Effect of Setria Performance Blend on Endurance Performance

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2019
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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