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Completed

NCT Number: NCT02819219

Effects of ElevATP on Body Composition and Athletic Performance

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplemental

Dietary Supplement

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

Other names: ElevATP, PurEnergy

Exercise intervention

Other

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

Primary outcomes

  1. Change in Body Fat (in kilograms)

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

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

  2. Change in Muscle Mass (in kilograms)

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

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

  3. Change in Body Fat percent (%)

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

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

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

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

    Measured by ultrasound at 75% femur length.

  5. Change in Maximal strength (in kilograms)

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

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

  6. Change in Power output (in watts)

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

    Measured by linear force transducer and cycle ergometer

  7. Change in vertical jump height (in centimeters)

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

    Measured by vertec.

Secondary outcomes

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

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

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

  2. Change in red blood cells (number of cells per unit of blood volume)

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

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

  3. Change in platelets (number of cells per unit of blood volume)

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

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

  4. Change in neutrophils (number of cells per unit of blood volume)

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

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

  5. Change in eosinophils (number of cells per unit of blood volume)

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

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

  6. Change in basophils (number of cells per unit of blood volume)

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

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

  7. Change in monocytes (number of cells per unit of blood volume)

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

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

  8. Change in lymphocytes. (number of cells per unit of blood volume)

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

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

  9. Change in hemoglobin (grams per deciliter)

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

    measured by third party, LabCorp

  10. Change in mean corpuscular hemoglobin concentration (grams per deciliter)

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

    measured by third party, LabCorp

  11. Change in hematocrit (%)

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

    measured by third party, LabCorp

  12. Change in red blood cell distribution width (%)

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

    measured by third party, LabCorp

  13. Change in mean corpuscular volume (fL)

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

    measured by third party, LabCorp

  14. Change in mean corpuscular hemoglobin (pg)

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

    measured by third party, LabCorp

  15. Change in serum glucose (mg/dL)

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

    measured by third party, LabCorp

  16. Change in blood urea nitrogen (mg/dL)

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

    measured by third party, LabCorp

  17. Change in creatinine (mg/dL)

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

    measured by third party, LabCorp

  18. Change in calcium (mg/dL)

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

    measured by third party, LabCorp

  19. 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)

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

    measured by third party, LabCorp

  20. Change in total protein (mg/dL)

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

    measured by third party, LabCorp

  21. Change in albumin (mg/dL)

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

    measured by third party, LabCorp

  22. Change in globulin (mg/dL)

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

    measured by third party, LabCorp

  23. Change in bilirubin (mg/dL)

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

    measured by third party, LabCorp

  24. Change in total cholesterol (mg/dL)

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

    measured by third party, LabCorp

  25. Change in triglycerides (mg/dL)

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

    measured by third party, LabCorp

  26. Change in high-density lipoprotein (mg/dL)

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

    measured by third party, LabCorp

  27. Change in low-density lipoprotein (mg/dL)

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

    measured by third party, LabCorp

  28. Change in very low density lipoprotein (mg/dL)

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

    measured by third party, LabCorp

  29. Change in estimated glomerular filtration rate (mL/min/1.73)

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

    measured by third party, LabCorp

  30. Change in serum sodium (mmol/L)

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

    measured by third party, LabCorp

  31. Change in serum potassium (mmol/L)

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

    measured by third party, LabCorp

  32. Change in serum chloride (mmol/L)

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

    measured by third party, LabCorp

  33. Change in serum carbon dioxide (mmol/L)

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

    measured by third party, LabCorp

  34. Change in aspartate aminotransferase (IU/L)

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

    measured by third party, LabCorp

  35. Change in alanine aminotransferase (IU/L)

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

    measured by third party, LabCorp

  36. Change in alkaline phosphatase (IU/L)

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

    measured by third party, LabCorp

  37. Change in Irisin (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  38. Change in Interleukin-6 (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  39. Change in interleukin-15 (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  40. Change in fibroblast growth factor-21 (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  41. Change in myonectin (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  42. Change in cortisol (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  43. Change in c-reactive protein (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

  44. Change in growth differentiation factor-11 (pg/mL)

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

    measured by enzyme-linked immunosorbent assay

Sponsors and collaborators

Lead sponsor

MusclePharm Sports Science Institute

Industry

Collaborators

  • VDF FutureCeuticals Inc.

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2016
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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