Muscle HypotrophyNCT05681806
Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men
A study testing Carnipure AAS and Creatine Monohydrate in people with Muscle Hypotrophy, run by Applied Science & Performance Institute at 1 site in United States.
Trial summary
This study is a 12-week randomized active control trial that is investigating the effects of Carnipure(R) AAS on muscle hypertrophy, body composition, and muscular strength adaptations in healthy men performing a resistance training program. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Hypotrophy
- What is being tested?
- Carnipure AAS and Creatine Monohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2023to 12 May 2025
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects 18-40 years old
- Recreationally trained (<1-year of training experience)
- Not currently consuming any ergogenic supplements or performance enhancing drugs
- Body mass index (BMI) 18-35 kg/m2
- No recent injuries that would contraindicate participation in a resistance training program
- Willing and able to give written informed consent
- Able to read, understand, sign and date the informed consent document (English only)
- Able and willing to comply with the schedule visit(s) and study requirements.
Who cannot join
- Currently taking (within the past 30 days) ergogenic dietary supplements including, creatine, protein, amino acids, or stimulants other than caffeine (yohimbe, ephedrine, etc.)
- Currently taking performance enhancing drugs (testosterone or other anabolic-androgenic steroids), human growth hormone, insulin, etc.
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Musculoskeletal disease (muscular dystrophy, arthritis, etc.)
- Recent (<3-months) musculoskeletal injuries
Show all 20Show fewer
- BMI <18 or >5 kg/m2
- Diagnosis of a terminal illness
- Use of prescription medications that influence muscle anabolism (i.e., prescription hormone therapies, etc.)
- History of alcohol abuse
- History or current drug abuse
- History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
- Insulin-dependent diabetes and/or metformin use
- Chronic kidney or liver disease
- Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such conditions might be aggravated as a result of treatment
- The investigator feels that for any reason the subject is not eligible to participate in the study
- History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
- A family member of the investigator or an employee of the investigator
- Participation in any other investigational study within 30 days prior to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science and Performance Institute
Tampa, Florida, 33607
About this study
Official title: Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men Following a 12-week Strength Training Program
This study is a 12-week randomized active control trial that is investigating the effects of Carnipure(R) AAS on muscle hypertrophy, body composition, and muscular strength adaptations in healthy men performing a resistance training program.
Read the detailed description
The study will enroll approximately 45 healthy males (18-40 year old and BMI 18.5-35kg/m2), who are recreationally trained and not presently taking any ergogenic nutritional supplements. Only male subjects will be selected to limit variability in lean mass at baseline as this is the primary variable of interest.
This study will be a 12-week exercise intervention, and will require experienced scientific staff for supervision of subjects. Below are a list of measures to be taken at 0, 6, and 12 weeks.
Primary Measures: these measures will be taken at time 0, 6, and 12-weeks post treatment
- Body composition (Lean and Fat mass) as determined by DXA Secondary Measures: these measures will be taken at time 0, 6, and 12-weeks post treatment
- Pectoral muscle thickness quantification via ultrasonography
- Bench press strength
- Muscle endurance (measured by reps to failure at 50 % 1RM assessed 5 minutes post strength testing)
- Full body strength as assessed by isometric mid thigh pull
- Lower body power as measured by a dual platform ground reaction force plate
Exercise Intervention The exercise intervention will be a 12-week periodized strength training program designed to promote muscle hypertrophy and enhance muscular strength. The 12-weeks will be divided into three 4-week mesocycles in which participants will perform the same exercise routine for 4-weeks before progressing to the next 4-week mesocycle. Participants will train 2x/week with 72-hours of rest between sessions to ensure adequate recovery. All training sessions are designed to last 45-60 minutes (including warmup) and all training sessions will be supervised by a certified personal trainer to ensure proper execution and safety. Two to three minutes of rest will be provided between each set to optimize training adaptations.
- Conditions
- Muscle Hypotrophy
- Being tested
- Carnipure AAS, Creatine Monohydrate
- Keywords
- Carnipure, Body Composition, Muscle Hypertrophy, Creatine, Muscle Strength
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carnipure AASDietary supplement
A combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate
Creatine MonohydrateDietary supplement
5g creatine monohydrate
| Study group | Role | What they receive |
|---|---|---|
| Treatment High Dose | Experimental | Subjects consuming 1000mg LMP Creatine + 500mg Carnipure crystalline 1x/day Receives: Dietary Supplement: Carnipure AAS |
| Treatment Low Dose | Experimental | Subjects consuming 500mg LMP Creatine + 500mg Carnipure crystalline 1x/day Receives: Dietary Supplement: Carnipure AAS |
| Active Control | Active comparator | Subjects consuming 5g creatine monohydrate 1x/day Receives: Dietary Supplement: Creatine Monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Changes in lean mass and fat mass as measured via dual x-ray absorptiometry
Measured: 12 weeks
Secondary outcomes (3)
Muscle Hypertrophy
Changes in pectoral muscle thickness as measured by b-mode ultrasound
Measured: 12 weeks
Muscle Strength
Changes in bench press 1RM and isometric mid-thigh pull maximum strength
Measured: 12 weeks
Lower Body Power
Changes in lower body power as measured by a dual ground reaction force plate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start23 Feb 2023
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle HypotrophyStudies 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
- Model description
- Participants will be randomized into three parallel groups: two treatment groups of differing Carnipure AAS doses and one active control consuming creatine monohydrate
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Charlie Ottinger, Applied Science & Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681806
- Sponsor's protocol ID
- L091322
- Status last verified
- May 2025
- First submitted
- 28 Dec 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data are owned by the CRO (ASPI) and the sponsor (Lonza Consumer Health).
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men Following a 12-week Strength Training Program
- ClinicalTrials.gov ID
- NCT05681806
- Acronym / sponsor ID
- L091322
- Conditions
- Muscle Hypotrophy
- Keywords
- Carnipure, Body Composition, Muscle Hypertrophy, Creatine, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 12 Jan 2023 (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.
This study is a 12-week randomized active control trial that is investigating the effects of Carnipure(R) AAS on muscle hypertrophy, body composition, and muscular strength adaptations in healthy men performing a resistance training program.
Detailed description
The study will enroll approximately 45 healthy males (18-40 year old and BMI 18.5-35kg/m2), who are recreationally trained and not presently taking any ergogenic nutritional supplements. Only male subjects will be selected to limit variability in lean mass at baseline as this is the primary variable of interest.
This study will be a 12-week exercise intervention, and will require experienced scientific staff for supervision of subjects. Below are a list of measures to be taken at 0, 6, and 12 weeks.
Primary Measures: these measures will be taken at time 0, 6, and 12-weeks post treatment
- Body composition (Lean and Fat mass) as determined by DXA Secondary Measures: these measures will be taken at time 0, 6, and 12-weeks post treatment
- Pectoral muscle thickness quantification via ultrasonography
- Bench press strength
- Muscle endurance (measured by reps to failure at 50 % 1RM assessed 5 minutes post strength testing)
- Full body strength as assessed by isometric mid thigh pull
- Lower body power as measured by a dual platform ground reaction force plate
Exercise Intervention The exercise intervention will be a 12-week periodized strength training program designed to promote muscle hypertrophy and enhance muscular strength. The 12-weeks will be divided into three 4-week mesocycles in which participants will perform the same exercise routine for 4-weeks before progressing to the next 4-week mesocycle. Participants will train 2x/week with 72-hours of rest between sessions to ensure adequate recovery. All training sessions are designed to last 45-60 minutes (including warmup) and all training sessions will be supervised by a certified personal trainer to ensure proper execution and safety. Two to three minutes of rest will be provided between each set to optimize training adaptations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized into three parallel groups: two treatment groups of differing Carnipure AAS doses and one active control consuming creatine monohydrate
| Arm | Type | Receives |
|---|---|---|
| Treatment High Dose | Experimental | Dietary Supplement: Carnipure AASSubjects consuming 1000mg LMP Creatine + 500mg Carnipure crystalline 1x/day |
| Treatment Low Dose | Experimental | Dietary Supplement: Carnipure AASSubjects consuming 500mg LMP Creatine + 500mg Carnipure crystalline 1x/day |
| Active Control | Active comparator | Dietary Supplement: Creatine MonohydrateSubjects consuming 5g creatine monohydrate 1x/day |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male subjects 18-40 years old
- Recreationally trained (<1-year of training experience)
- Not currently consuming any ergogenic supplements or performance enhancing drugs
- Body mass index (BMI) 18-35 kg/m2
- No recent injuries that would contraindicate participation in a resistance training program
Key exclusion criteria (20 listed)
- Currently taking (within the past 30 days) ergogenic dietary supplements including, creatine, protein, amino acids, or stimulants other than caffeine (yohimbe, ephedrine, etc.)
- Currently taking performance enhancing drugs (testosterone or other anabolic-androgenic steroids), human growth hormone, insulin, etc.
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Musculoskeletal disease (muscular dystrophy, arthritis, etc.)
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 |
|---|---|---|
| Carnipure AASA combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate | Dietary supplement | Treatment High Dose, Treatment Low Dose |
| Creatine Monohydrate5g creatine monohydrate | Dietary supplement | Active Control |
Primary outcome
Body Composition
Time frame: 12 weeks
Changes in lean mass and fat mass as measured via dual x-ray absorptiometry
3 secondary outcomes
Muscle Hypertrophy
Time frame: 12 weeks
Muscle Strength
Time frame: 12 weeks
Lower Body Power
Time frame: 12 weeks
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 16 May 2025.
- Individual participant dataSharing planned: No. All data are owned by the CRO (ASPI) and the sponsor (Lonza Consumer Health).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carnipure AAS and Creatine Monohydrate in people with Muscle Hypotrophy, run by Applied Science & Performance Institute 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 8 inclusion and 20 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 16 May 2025. 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. 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?
Body Composition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.