Acute Study on Muscle Soreness, Damage, and Performance

NCT04230226 | Completed

• 1 other identifier: 20-PHX-0001 Acute
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Soreness, Muscle; Performance Enhancing Product Use; Damage Muscle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Muscle soreness

  baseline, 24 hours, 48 hours

• Creatine Kinase

  baseline, 24 hours, 48 hours

• Isoprostanes

  baseline, 24 hours, 48 hours

Study Arms (2)

Pre-workout and Post-workout Product

ACTIVE COMPARATOR

Pre-workout plus: a blend of caffeine, choline bitartrate, carbohydrate, HMB, vitamin D3 mixed with water and consumed within 30 minutes prior to exercise Protein recovery plus: a blend of whey protein, caseinate, carbohydrate, vitamin C, alpha-tocopherol, vitamin D3, glucosamine mixed with water and consumed 15 minutes post exercise

Dietary Supplement: Pre-workout plus and protein recovery plus

Study Placebo

PLACEBO COMPARATOR

non-caloric powder mixed with water consumed within 30 minutes prior to exercise and within 15 minutes post exercise

Other: Placebo

Interventions

Pre-workout plus and protein recovery plus DIETARY_SUPPLEMENT

Study products consumed prior and after exercise

Pre-workout and Post-workout Product

Placebo OTHER

Placebo product consumed prior and after exercise

Study Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: January 21, 2020
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)