Setria Performance Blend Supplementation

NCT04090138 | Completed

• 1 other identifier: 19-1375
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

endurance performance, l-citrulline, glutathione

Outcome Measures

Primary Outcomes (3)

• Change in Time to exhaustion (sec)

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

  8 days

• Change in Blood Flow (ml/min-1)

  Measured from ultrasound before and after 8 days of supplementation

  8 days

• Change in Vessel Diameter (mm)

  Measured from ultrasound before and after 8 days of supplementation

  8 days

Study Arms (2)

Setria performance blend

ACTIVE COMPARATOR

l-citrulline + glutathione

Dietary Supplement: Setria performance blend

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Setria performance blend DIETARY_SUPPLEMENT

Oral capsules

Also known as: l-citrulline + glutathione

Setria performance blend

Placebo DIETARY_SUPPLEMENT

Oral capsules

Placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: All subjects must identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Kirin Holdings Company, Limited: collaborator

Study Sites (1)

Applied Physiology Laboratory, Fetzer Hall Room 25

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 37125500 DERIVED

MeSH Terms

Interventions

Citrulline; Glutathione

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins; Oligopeptides; Peptides

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each subject and their associated information will be identified by a 4-digit alpha-numerical identification code.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: November 30, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication
• Access Criteria: IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC and Kirin Holdings Co, Ltd

Locations

US (1)