Clinical trial NCT04230824: Chronic Study on Body Composition, Training, Performance, and Recovery
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: Damage Muscle
Body Weight Changes
Performance Enhancing Product Use
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2020-01-18
Enrollment: 69
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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 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

Primary outcomes:
measure: Strength
timeFrame: baseline, week 8
Secondary outcomes:
measure: Muscle soreness
timeFrame: baseline, week 8
measure: Recovery
timeFrame: baseline, week 8
measure: Training Volume
timeFrame: baseline, week 8
measure: Performance
timeFrame: baseline, week 8
measure: Body Composition
timeFrame: baseline, week 8
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: