Chronic Study on Body Composition, Training, Performance, and Recovery

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

The chronic phase of the study will evaluate the effects of pre-exercise and post-exercise ingestion of a multi-ingredient supplement on adaptations to a 6-week exercise program consisting of both resistance training and high intensity aerobic exercise, using a randomized, double-blind, placebo-controlled design. Participants will complete an enrollment/familiarization visit, a baseline testing session, followed by a 6-week supervised exercise intervention, and post-testing session identical to baseline testing. Participants will be randomized during the baseline session to groups receiving either 1) Active Treatment (pre-post supplementation), 2) placebo (noncaloric beverage), or 3) control, not participating in exercise or consuming a treatment. During the supervised 6-week resistance training program, participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week). Thirty-minutes prior to each training session, and within 15 minutes post-exercise, participants will consume their randomly assigned treatment beverage. Body composition, blood markers of muscle damage/recovery, strength, and performance tests will be measured before (baseline) and after training (Post) to evaluate the effects of supplementation. All data collection will be conducted by the Principal Investigator and Research Assistants. All subjects will report to the Applied Physiology Laboratory and Human Performance Center in Fetzer Hall for all testing and training sessions, which will span approximately 8 weeks.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes; Performance Enhancing Product Use; Damage Muscle
• Intervention / Treatment: Dietary supplement: Pre-workout plus and Protein recovery plus; Other: 6-week resistance training program; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 or for exercise related pain or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage
• Participant agrees to wear an accelerometer to track activity during entire study
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This arm will receive no intervention
Active Comparator: Pre-workout plus and Protein recovery plus; 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; products consumed prior and after exercise; Other: 6-week resistance training program; participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week)
Placebo Comparator: Placebo; Non-caloric powder mixed with water and consumed within 30 minutes prior to exercise and within 15 minutes after exercise	Other: 6-week resistance training program; participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week); Other: Placebo; placebo product consumed prior and after exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	Change from baseline in strength by measuring 1 repetition maximum for leg press and bench press	baseline, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, week 8
Recovery	Change from baseline on muscle damage by measuring creatine kinase and isoprostanes	baseline, week 8
Training Volume	Change from baseline in total training volume measured by product of sets x repetitions completed x external load used in exercise routine	baseline, week 8
Performance	Change from baseline on performance by measuring countermovement vertical jump	baseline, week 8
Body Composition	Change from baseline in body composition using DXA measurements fat mass (kg) and lean mass (kg)	baseline, week 8

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: 20-PHX-0001 Chronic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No