Performance Enhancing Product Use Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled, Single-center Study to Determine the Effects of Pre-workout and Recovery Formulations on Soreness, Performance, Tolerance and Safety Outcomes in Healthy Adults Undergoing Training Program
Verified date | November 2020 |
Source | Pharmanex |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design. Participants will complete one enrollment visit, in which they will sign a consent form and complete a health history questionnaire. Participants will complete two interventions, with three visits each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes post-exercise, in random order. Total time from enrollment to completion will be at least 14 days. Testing visits will be separated by a minimum of 7 days of rest to allow for recovery and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 16, 2020 |
Est. primary completion date | September 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 50 Years |
Eligibility | Inclusion Criteria: - Participant is an adult between the ages of 25-50 years - Participant has a recorded BMI of 20-35 kg/m2 - Participant exercises less than 3 hours per week for at least 8 weeks preceding the study - Participant has provided written and dated informed consent to participate in the study - Participant is willing to and able to comply with the protocol - Participant is apparently healthy and no reported metabolic disorders, heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire - Participant agrees to maintain current diet and exercise routine during the study - Participant agrees to refrain from taking any anti-inflammatory supplement 48 hours prior to exercise (acute) or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage - Participant has a resting (seated for 5 minutes) blood pressure of systolic pressure between 140-90 mmHg and a diastolic pressure between 90-50 mmHg Exclusion Criteria: - Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement - Participant is using, or has consistently used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, HMB, Carnosine, Vitamin D - Participant has consistently consumed whey protein/plant protein and/or 1,000 mg of fish oil within the previous 4 weeks prior to enrollment - Participant has gained or lost = 8 lbs in the previous month - Participant has a known allergy or sensitivity to the placebo or active ingredients - Participant has used tobacco more than three days per week (on average) in the previous 6 months, or refuses to abstain from all tobacco use for the duration of the study - Participant is pregnant or planning to become pregnant - Participant has any musculoskeletal condition prohibiting them from participation |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pharmanex | University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance | Change from baseline on performance by measuring countermovement vertical jump height using a jump mat and associated velocity using a linear transducer. | baseline, 24 hours, 48 hours | |
Secondary | Muscle soreness | Change from baseline on muscle soreness using visual analog scale (a horizontal 100 mm line where zero will represent no soreness and one-hundred will represent maximum amount of soreness. Participants will be asked to place a single vertical that represents their current soreness. The scale will be measured with a calibrated ruler with the higher numbers representing more soreness.) | baseline, 24 hours, 48 hours | |
Secondary | Creatine Kinase | Change from baseline on muscle damage by measuring creatine kinase | baseline, 24 hours, 48 hours | |
Secondary | Isoprostanes | Change from baseline on muscle damage by measuring isoprostanes | baseline, 24 hours, 48 hours |
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