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

Primary Purpose

Muscle Hypotrophy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carnipure AAS
Creatine Monohydrate
Sponsored by
Applied Science & Performance Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Hypotrophy focused on measuring Carnipure, Body Composition, Muscle Hypertrophy, Creatine, Muscle Strength

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Applied Science and Performance InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment High Dose

Treatment Low Dose

Active Control

Arm Description

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

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

Subjects consuming 5g creatine monohydrate 1x/day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2022
Last Updated
May 25, 2023
Sponsor
Applied Science & Performance Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05681806
Brief Title
Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
August 9, 2023 (Anticipated)
Study Completion Date
August 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Applied Science & Performance Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Hypotrophy
Keywords
Carnipure, Body Composition, Muscle Hypertrophy, Creatine, Muscle Strength

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
This is an open label trial.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment High Dose
Arm Type
Experimental
Arm Description
Subjects consuming 1000mg LMP Creatine + 500mg Carnipure crystalline 1x/day
Arm Title
Treatment Low Dose
Arm Type
Experimental
Arm Description
Subjects consuming 500mg LMP Creatine + 500mg Carnipure crystalline 1x/day
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Subjects consuming 5g creatine monohydrate 1x/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Carnipure AAS
Intervention Description
A combination of a low dose of Carnipure crystalline (L-carnitine tartrate) and lipid multi-particulate (LMP) creatine monohydrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Monohydrate
Intervention Description
5g creatine monohydrate
Primary Outcome Measure Information:
Title
Body Composition
Description
Changes in lean mass and fat mass as measured via dual x-ray absorptiometry
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle Hypertrophy
Description
Changes in pectoral muscle thickness as measured by b-mode ultrasound
Time Frame
12 weeks
Title
Muscle Strength
Description
Changes in bench press 1RM and isometric mid-thigh pull maximum strength
Time Frame
12 weeks
Title
Lower Body Power
Description
Changes in lower body power as measured by a dual ground reaction force plate
Time Frame
12 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
This study is limited to male participants.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Applied Science and Performance Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Ottinger, PhD
Phone
813-673-8888
Email
cottinger@theaspi.com
First Name & Middle Initial & Last Name & Degree
Matthew Sharp, MS
Phone
813-673-8888
Email
msharp@theaspi.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data are owned by the CRO (ASPI) and the sponsor (Lonza Consumer Health).

Learn more about this trial

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

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