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

NCT05681806 | Completed

• 1 other identifier: L091322
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Hypotrophy

Keywords

Carnipure; Body Composition; Muscle Hypertrophy; Creatine; Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Body Composition

  Changes in lean mass and fat mass as measured via dual x-ray absorptiometry

  12 weeks

Secondary Outcomes (3)

• Muscle Hypertrophy

  12 weeks

• Muscle Strength

  12 weeks

• Lower Body Power

  12 weeks

Study Arms (3)

Treatment High Dose

EXPERIMENTAL

Subjects consuming 1000mg LMP Creatine + 500mg Carnipure crystalline 1x/day

Dietary Supplement: Carnipure AAS

Treatment Low Dose

EXPERIMENTAL

Subjects consuming 500mg LMP Creatine + 500mg Carnipure crystalline 1x/day

Dietary Supplement: Carnipure AAS

Active Control

ACTIVE COMPARATOR

Subjects consuming 5g creatine monohydrate 1x/day

Dietary Supplement: Creatine Monohydrate

Interventions

Carnipure AAS DIETARY_SUPPLEMENT

A combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate

Treatment High Dose; Treatment Low Dose

Creatine Monohydrate DIETARY_SUPPLEMENT

5g creatine monohydrate

Active Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is limited to male participants.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Creatine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label trial.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Participants will be randomized into three parallel groups: two treatment groups of differing Carnipure AAS doses and one active control consuming creatine monohydrate

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: February 23, 2023
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)