Setria Performance Blend Supplementation

The Effect of Setria Performance Blend on Endurance Performance

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Setria performance blend; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Applied Physiology Laboratory, Fetzer Hall Room 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; Oral capsules
ACTIVE_COMPARATOR: Setria performance blend; l-citrulline + glutathione	Dietary supplement: Setria performance blend; Oral capsules; Other Names: l-citrulline + glutathione

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Kirin Holdings Company, Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2019
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (ACTUAL): September 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: endurance performance, l-citrulline, glutathione
• Other Study ID Numbers: 19-1375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC and Kirin Holdings Co, Ltd
• IPD Sharing Time Frame: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication
• IPD Sharing Access Criteria: IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC and Kirin Holdings Co, Ltd
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No