Setria Performance Blend Supplementation

NCT ID: NCT04090138

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2020-11-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Setria performance blend

l-citrulline + glutathione

Group Type: ACTIVE_COMPARATOR

Setria performance blend

Intervention Type: DIETARY_SUPPLEMENT

Oral capsules

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral capsules

Interventions

Setria performance blend

Oral capsules

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral capsules

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

l-citrulline + glutathione

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kirin Holdings Company, Limited

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbie Smith-Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Applied Physiology Laboratory, Fetzer Hall Room 25

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37125500 (View on PubMed)

Other Identifiers

19-1375

Identifier Type: -

Identifier Source: org_study_id