Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05681806
Other study ID # L091322
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 23, 2023
Est. completion date August 26, 2024

Study information

Verified date June 2024
Source Applied Science & Performance Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date August 26, 2024
Est. primary completion date August 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Carnipure AAS
A combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate
Creatine Monohydrate
5g creatine monohydrate

Locations

Country Name City State
United States Applied Science and Performance Institute Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Applied Science & Performance Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Composition Changes in lean mass and fat mass as measured via dual x-ray absorptiometry 12 weeks
Secondary Muscle Hypertrophy Changes in pectoral muscle thickness as measured by b-mode ultrasound 12 weeks
Secondary Muscle Strength Changes in bench press 1RM and isometric mid-thigh pull maximum strength 12 weeks
Secondary Lower Body Power Changes in lower body power as measured by a dual ground reaction force plate 12 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05573321 - The Effect of Blood Flow Restriction (Bfr) Exercise on Acute Systemic Myokine Levels in Healthy Trained Men N/A
Active, not recruiting NCT03054168 - Systemic Hormones and Muscle Protein Synthesis Phase 3