Acute Study on Muscle Soreness, Damage, and Performance

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230226
• Other study ID #: 20-PHX-0001 Acute
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: September 16, 2020

Study information

• Verified date: November 2020
• Source: Pharmanex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Damage Muscle
• Myalgia
• Performance Enhancing Product Use
• Soreness, Muscle

Intervention

Dietary Supplement:
• Pre-workout plus and protein recovery plus
Study products consumed prior and after exercise

Other:
• Placebo
Placebo product consumed prior and after exercise

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Pharmanex	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

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