Acute Study on Muscle Soreness, Damage, and Performance

Pharmanex32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Soreness, Muscle Performance Enhancing Product Use Damage Muscle

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Performance

Change from baseline on performance by measuring countermovement vertical jump height using a jump mat and associated velocity using a linear transducer.

Time frame: baseline, 24 hours, 48 hours

Secondary Outcomes

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.)

Time frame: baseline, 24 hours, 48 hours

Creatine Kinase

Change from baseline on muscle damage by measuring creatine kinase

Time frame: baseline, 24 hours, 48 hours

Isoprostanes

Change from baseline on muscle damage by measuring isoprostanes

Time frame: baseline, 24 hours, 48 hours

Acute Study on Muscle Soreness, Damage, and Performance

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes