Clinical trial NCT02819219: Effects of ElevATP on Body Composition and Athletic Performance
Official title: Effects of ElevATP on Body Composition and Athletic Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Dietary Supplements
Exercise
Lead sponsor: MusclePharm Sports Science Institute
Sponsor class: INDUSTRY
Collaborators: name: VDF FutureCeuticals Inc.
First posted: 2016-06-30
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Fat (in kilograms)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
measure: Change in Muscle Mass (in kilograms)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
measure: Change in Body Fat percent (%)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
measure: Change in Cross-sectional area of the rectus femoris (cm squared)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
measure: Change in Maximal strength (in kilograms)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
measure: Change in Power output (in watts)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
measure: Change in vertical jump height (in centimeters)
timeFrame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
Secondary outcomes:
measure: Change in white blood cells (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in red blood cells (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in platelets (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in neutrophils (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in eosinophils (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in basophils (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in monocytes (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in lymphocytes. (number of cells per unit of blood volume)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in hemoglobin (grams per deciliter)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in mean corpuscular hemoglobin concentration (grams per deciliter)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in hematocrit (%)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in red blood cell distribution width (%)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in mean corpuscular volume (fL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in mean corpuscular hemoglobin (pg)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in serum glucose (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in blood urea nitrogen (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in creatinine (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in calcium (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in serum glucose, blood urea nitrogen, creatinine, calcium, total protein, albumin, globulin, bilirubin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, and very low density lipoprotein (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in total protein (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in albumin (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in globulin (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in bilirubin (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in total cholesterol (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in triglycerides (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in high-density lipoprotein (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in low-density lipoprotein (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in very low density lipoprotein (mg/dL)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in estimated glomerular filtration rate (mL/min/1.73)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in serum sodium (mmol/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in serum potassium (mmol/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in serum chloride (mmol/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in serum carbon dioxide (mmol/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in aspartate aminotransferase (IU/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in alanine aminotransferase (IU/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in alkaline phosphatase (IU/L)
timeFrame: measure at 0, 8, and 12 weeks of the intervention
measure: Change in Irisin (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in Interleukin-6 (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in interleukin-15 (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in fibroblast growth factor-21 (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in myonectin (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in cortisol (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in c-reactive protein (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
measure: Change in growth differentiation factor-11 (pg/mL)
timeFrame: measure at 0, 4, 8, and 12 weeks of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: MusclePharm Sports Science Institute
name: jordan m joy, ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joy JM, Vogel RM, Moon JR, Falcone PH, Mosman MM, Pietrzkowski Z, Reyes T, Kim MP. Ancient peat and apple extracts supplementation may improve strength and power adaptations in resistance trained men. BMC Complement Altern Med. 2016 Jul 18;16:224. doi: 10.1186/s12906-016-1222-x.