Effects of ElevATP on Body Composition and Athletic Performance

N/ACompletedNCT02819219

MusclePharm Sports Science Institute51 enrolled

Overview

This study will examine the effects of supplemental ElevATP with or without a blend of extended-release caffeine and B vitamins for changes in body composition, athletic performance, and hematology over a 12 week intervention period.

In a double-blind, placebo, diet, and training controlled design, 57 subjects will participate in an eight week, resistance and high intensity interval training study to assess the ergogenic potential of elevATP with and without caffeine plus vitamins in comparison to a visually identical, equal volume placebo within a periodized training program (described below). Prior to testing or training, subjects will report to the laboratory for screening and familiarization with testing protocols. The following week, subjects will complete baseline testing for all measurements including a 3 day food log. During the next eight weeks, subjects will participate in a periodized resistance training program which alters the repetition and loading schemes daily and weekly. During the entirety of the training protocol, subjects will supplement daily with either 1 serving of elevATP, 1 serving of Dropz (elevATP + caffeine), or 1 serving of an equal volume, visually identical placebo. Measurements will be repeated at the end of weeks 4 and 8, 10, and 12. Variables collected: * Dual Emissions X-Ray Absorptiometry (DEXA) determined (weeks 0, 4, 8, 10, 12): * Body fat * Lean body mass * Body fat percentage * Bioelectric Impedance Analysis and Spectroscopy (BIA/BIS) determined (weeks 0, 4, 8, 10, 12): * Body fat * Lean body mass * Body fat percentage * Ultrasonography determined cross-sectional area (weeks 0, 4, 8 , 10, 12) * 1-repetition maximum (1RM) strength of the squat (weeks 0, 4, 8 , 10, 12) * 1RM strength of the bench press (weeks 0, 4, 8 , 10, 12) * 1RM strength of the deadlift (weeks 0, 4, 8 , 10, 12) * Vertical jump height and power (weeks 0, 4, 8 , 10, 12) * Bench press power (weeks 0, 4, 8 , 10, 12) * Anaerobic peak and average power output (weeks 0, 4, 8 , 10, 12) * Blood count, metabolic, and lipid safety panels (weeks 0, 8, and 12) * Anthropometrics (weeks 0, 4, 8 , 10, 12) * Vital Signs (weeks 0, 4, 8 , 10, 12) * Myokines and biomarkers of regeneration panels (weeks 0, 4, 8, and 12): Analysis to be performed by VDF FutureCeuticals, Inc. MusclePharm to ship frozen serum samples (1-2ml) from all subjects to VDF FutureCeuticals, care of Zbigniew Pietrzkowski, 16259 Laguna Canyon Rd, Irvine, CA 92618 Resistance training protocol Will consist of a daily undulating periodization design with high volume, high velocity, and high intensity workouts. Exercises performed will be the back squat, bench press, deadlift, leg press, bent row, shoulder press, pulldown, dips, bicep curl, tricep extension, single-arm row, hammer strength chest press, lateral raise, incline bench press, power squat, leg extension, and leg curl. Exercises will be performed for 1-15 repetitions, 3-5 sets, and with 0.5-5 minutes rest between sets. Diet Each subject will receive a personalized diet to suit their individual needs. Total calories will be calculated based on the Mifflin St. Jeor equation. One half of total calories will be derived from carbohydrates, while fats and proteins will equally compose the remaining one half of total calories.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

SupplementalDIETARY_SUPPLEMENT

participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.

Exercise InterventionOTHER

Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18-35 years * Healthy as assessed by Pre-exercise Testing Health Status and General Information Questionnaire * Strength trained for a minimum of 3 years as assessed by pre-exercise testing questionnaire * Minimum strength requirements of 1x bodyweight bench press and 1.5x bodyweight squat and deadlift. * Subject has provided written and dated informed consent to participate in the study Exclusion Criteria: * Having a history of medical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders * Use of medicine that may significantly affect the study outcome * Use of any ergogenic aids for one month prior to the onset of the study

Outcomes

Primary Outcomes

Change in Body Fat (in kilograms)

Measured by dual emissions x-ray absorptiometry (DEXA), bioelectric impedance analysis (BIA), and bioelectric impedance spectroscopy (BIS)

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Change in Muscle Mass (in kilograms)

Measured by dual emissions x-ray absorptiometry (DEXA), bioelectric impedance analysis (BIA), and bioelectric impedance spectroscopy (BIS)

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Change in Body Fat percent (%)

Measured by dual emissions x-ray absorptiometry (DEXA), bioelectric impedance analysis (BIA), and bioelectric impedance spectroscopy (BIS)

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Change in Cross-sectional area of the rectus femoris (cm squared)

Measured by ultrasound at 75% femur length.

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Change in Maximal strength (in kilograms)

Measured by 1-repetition maximum in the squat, bench press, and deadlift exercises.

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Change in Power output (in watts)

Measured by linear force transducer and cycle ergometer

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Change in vertical jump height (in centimeters)

Measured by vertec.

Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention

Secondary Outcomes

Data from ClinicalTrials.gov

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Change in white blood cells (number of cells per unit of blood volume)

measured by third party, Laboratory Corporation of America (LabCorp)