Effects of ElevATP on Body Composition and Athletic Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of ElevATP on Body Composition and Athletic Performance

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Supplemental
* Other: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will receive a flavored water placebo supplement. Part of the supplemental intervention. This, and all groups, simultaneously took part in the exercise intervention. | Dietary Supplement: Supplemental<br>* participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.<br>* Other names: ElevATP, PurEnergy;Other: Exercise Intervention<br>* Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.<br>|
| Experimental: ElevATP<br>Participants will receive the flavored water placebo with an additional 150mg of ElevATP (blend of ancient peat and apple extracts). Part of the supplemental intervention.This, and all groups, simultaneously took part in the exercise intervention. | Dietary Supplement: Supplemental<br>* participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.<br>* Other names: ElevATP, PurEnergy;Other: Exercise Intervention<br>* Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.<br>|
| Experimental: ElevATP w/Caffeine<br>Participants will receive the flavored water placebo with an additional 150mg of ElevATP (blend of ancient peat and apple extracts), a 180 mg blend of caffeine (caffeine anhydrous, pterostilbene-bound caffeine), and 38mg B vitamins. Part of the supplemental intervention.This, and all groups, simultaneously took part in the exercise intervention. | Dietary Supplement: Supplemental<br>* participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.<br>* Other names: ElevATP, PurEnergy;Other: Exercise Intervention<br>* Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat (in kilograms) | Measured by dual emissions x-ray absorptiometry (DEXA), bioelectric impedance analysis (BIA), and bioelectric impedance spectroscopy (BIS) | 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) | 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) | 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. | 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. | 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 | measure at 0, 4, 8, 10, and 12 weeks of the intervention | 
| Change in vertical jump height (in centimeters) | Measured by vertec. | measure at 0, 4, 8, 10, and 12 weeks of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in white blood cells (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in red blood cells (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in platelets (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in neutrophils (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in eosinophils (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in basophils (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in monocytes (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in lymphocytes. (number of cells per unit of blood volume) | measured by third party, Laboratory Corporation of America (LabCorp) | measure at 0, 8, and 12 weeks of the intervention | 
| Change in hemoglobin (grams per deciliter) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in mean corpuscular hemoglobin concentration (grams per deciliter) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in hematocrit (%) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in red blood cell distribution width (%) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in mean corpuscular volume (fL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in mean corpuscular hemoglobin (pg) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in serum glucose (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in blood urea nitrogen (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in creatinine (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in calcium (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| 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) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in total protein (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in albumin (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in globulin (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in bilirubin (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in total cholesterol (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in triglycerides (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in high-density lipoprotein (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in low-density lipoprotein (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in very low density lipoprotein (mg/dL) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in estimated glomerular filtration rate (mL/min/1.73) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in serum sodium (mmol/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in serum potassium (mmol/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in serum chloride (mmol/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in serum carbon dioxide (mmol/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in aspartate aminotransferase (IU/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in alanine aminotransferase (IU/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in alkaline phosphatase (IU/L) | measured by third party, LabCorp | measure at 0, 8, and 12 weeks of the intervention | 
| Change in Irisin (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in Interleukin-6 (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in interleukin-15 (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in fibroblast growth factor-21 (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in myonectin (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in cortisol (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in c-reactive protein (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 
| Change in growth differentiation factor-11 (pg/mL) | measured by enzyme-linked immunosorbent assay | measure at 0, 4, 8, and 12 weeks of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Supplements, Exercise