Damage MuscleNCT04230824
Chronic Study on Body Composition, Training, Performance, and Recovery
A study testing Pre-workout plus and Protein recovery plus and 6-week resistance training program in people with Damage Muscle and Body Weight Changes, run by Pharmanex at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Damage Muscle, Body Weight Changes, Performance Enhancing Product Use
- What is being tested?
- Pre-workout plus and Protein recovery plus and 6-week resistance training program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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
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.
- Being tested
- Pre-workout plus and Protein recovery plus, Placebo, 6-week resistance training program
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-workout plus and Protein recovery plusDietary supplement
products consumed prior and after exercise
PlaceboOther
placebo product consumed prior and after exercise
6-week resistance training programOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Pre-workout plus and Protein recovery plus | 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 Receives: Dietary Supplement: Pre-workout plus and Protein recovery plus; Other: 6-week resistance training program |
| Placebo | Placebo comparator | Non-caloric powder mixed with water and consumed within 30 minutes prior to exercise and within 15 minutes after exercise Receives: Other: Placebo; Other: 6-week resistance training program |
| Control | No intervention | This arm will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Change from baseline in strength by measuring 1 repetition maximum for leg press and bench press
Measured: baseline, week 8
Secondary outcomes (5)
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.)
Measured: baseline, week 8
Recovery
Change from baseline on muscle damage by measuring creatine kinase and isoprostanes
Measured: 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
Measured: baseline, week 8
Performance
Change from baseline on performance by measuring countermovement vertical jump
Measured: baseline, week 8
Body Composition
Change from baseline in body composition using DXA measurements fat mass (kg) and lean mass (kg)
Measured: baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2021
- Primary completion1 Jul 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Damage MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230824
- Sponsor's protocol ID
- 20-PHX-0001 Chronic
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabre HE, Gordon AN, Patterson ND, Smith-Ryan AE. Evaluation of pre-workout and recovery formulations on body composition and performance after a 6-week high-intensity training program. Front Nutr. 2022 Nov 2;9:1016310. doi: 10.3389/fnut.2022.1016310. eCollection 2022.
PubMed 36407519
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04230824
- Acronym / sponsor ID
- 20-PHX-0001 Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-workout plus and Protein recovery plus | Active comparator | Dietary Supplement: Pre-workout plus and Protein recovery plus, Other: 6-week resistance training programPre-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 |
| Placebo | Placebo comparator | Other: Placebo, Other: 6-week resistance training programNon-caloric powder mixed with water and consumed within 30 minutes prior to exercise and within 15 minutes after exercise |
| Control | No intervention | –This arm will receive no intervention |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-workout plus and Protein recovery plusproducts consumed prior and after exercise | Dietary supplement | Pre-workout plus and Protein recovery plus |
| Placeboplacebo product consumed prior and after exercise | Other | Placebo |
| 6-week resistance training programparticipants 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, Pre-workout plus and Protein recovery plus |
Primary outcome
Strength
Time frame: baseline, week 8
Change from baseline in strength by measuring 1 repetition maximum for leg press and bench press
5 secondary outcomes
Muscle soreness
Time frame: baseline, week 8
Recovery
Time frame: baseline, week 8
Training Volume
Time frame: baseline, week 8
Performance
Time frame: baseline, week 8
Body Composition
Time frame: baseline, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 36407519Cabre HE, Gordon AN, Patterson ND, Smith-Ryan AE. Evaluation of pre-workout and recovery formulations on body composition and performance after a 6-week high-intensity training program. Front Nutr. 2022 Nov 2;9:1016310. doi: 10.3389/fnut.2022.1016310. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-workout plus and Protein recovery plus and 6-week resistance training program in people with Damage Muscle and Body Weight Changes, run by Pharmanex at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.