Clinical trial NCT04230226: Acute Study on Muscle Soreness, Damage, and Performance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soreness, Muscle
Performance Enhancing Product Use
Damage Muscle
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2020-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance
timeFrame: baseline, 24 hours, 48 hours
Secondary outcomes:
measure: Muscle soreness
timeFrame: baseline, 24 hours, 48 hours
measure: Creatine Kinase
timeFrame: baseline, 24 hours, 48 hours
measure: Isoprostanes
timeFrame: baseline, 24 hours, 48 hours
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: