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

Primary Purpose

Damage Muscle, Body Weight Changes, Performance Enhancing Product Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-workout plus and Protein recovery plus
Placebo
6-week resistance training program
Sponsored by
Pharmanex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Damage Muscle

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Pre-workout plus and Protein recovery plus

Placebo

Control

Arm Description

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

Non-caloric powder mixed with water and consumed within 30 minutes prior to exercise and within 15 minutes after exercise

This arm will receive no intervention

Outcomes

Primary Outcome Measures

Strength
Change from baseline in strength by measuring 1 repetition maximum for leg press and bench press

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2020
Last Updated
January 12, 2022
Sponsor
Pharmanex
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT04230824
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmanex
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Damage Muscle, Body Weight Changes, Performance Enhancing Product Use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-workout plus and Protein recovery plus
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Non-caloric powder mixed with water and consumed within 30 minutes prior to exercise and within 15 minutes after exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will receive no intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Pre-workout plus and Protein recovery plus
Intervention Description
products consumed prior and after exercise
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo product consumed prior and after exercise
Intervention Type
Other
Intervention Name(s)
6-week resistance training program
Intervention Description
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)
Primary Outcome Measure Information:
Title
Strength
Description
Change from baseline in strength by measuring 1 repetition maximum for leg press and bench press
Time Frame
baseline, week 8
Secondary Outcome Measure Information:
Title
Muscle soreness
Description
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, week 8
Title
Recovery
Description
Change from baseline on muscle damage by measuring creatine kinase and isoprostanes
Time Frame
baseline, week 8
Title
Training Volume
Description
Change from baseline in total training volume measured by product of sets x repetitions completed x external load used in exercise routine
Time Frame
baseline, week 8
Title
Performance
Description
Change from baseline on performance by measuring countermovement vertical jump
Time Frame
baseline, week 8
Title
Body Composition
Description
Change from baseline in body composition using DXA measurements fat mass (kg) and lean mass (kg)
Time Frame
baseline, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbie Smith-Ryan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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