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Setria Performance Blend Supplementation

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Setria performance blend
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04090138
19-1375

Details and patient eligibility

About

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

Full 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.

Enrollment

25 patients

Sex

Male

Ages

20 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

25 participants in 2 patient groups, including a placebo group

Setria performance blend
Active Comparator group
Description:
l-citrulline + glutathione
Treatment:
Dietary Supplement: Setria performance blend
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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