Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Hypotrophy
• Intervention / Treatment: Dietary supplement: Carnipure AAS; Dietary supplement: Creatine Monohydrate

Detailed Description

The study will enroll approximately 45 healthy males (18-30 year old and BMI 18.5-30kg/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 Exploratory Measures
• Subject perceived muscle soreness and recovery following training sessions

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 30-40 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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Applied Science and Performance Institute
      • Contact: Matthew Sharp, MS; Phone Number: 813-673-8888; Email: msharp@theaspi.com
      • Contact: Charlie Ottinger, PhD; Phone Number: 813-673-8888; Email: cottinger@theaspi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male subjects 18-40 years old
• Recreationally trained (>6-months but <1-year of training experience)
• Not currently consuming any ergogenic supplements or performance enhancing drugs
• Body mass index (BMI) 18-29 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 >30 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment High Dose; Subjects consuming 1000mg LMP Creatine + 500mg Carnipure crystalline 1x/day	Dietary supplement: Carnipure AAS; A combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate
Experimental: Treatment Low Dose; Subjects consuming 500mg LMP Creatine + 500mg Carnipure crystalline 1x/day	Dietary supplement: Carnipure AAS; A combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate
Active Comparator: Active Control; Subjects consuming 5g creatine monohydrate 1x/day	Dietary supplement: Creatine Monohydrate; 5g creatine monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Changes in lean mass and fat mass as measured via dual x-ray absorptiometry	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Hypertrophy	Changes in pectoral muscle thickness as measured by b-mode ultrasound	12 weeks
Muscle Strength	Changes in bench press 1RM and isometric mid-thigh pull maximum strength	12 weeks
Lower Body Power	Changes in lower body power as measured by a dual ground reaction force plate	12 weeks

Collaborators and Investigators

• Sponsor: Applied Science & Performance Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Estimated): August 9, 2024
• Study Completion (Estimated): August 26, 2024

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Body Composition; Muscle Strength; Creatine; Carnipure; Muscle Hypertrophy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: L091322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data are owned by the CRO (ASPI) and the sponsor (Lonza Consumer Health).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No