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Effects of ElevATP on Body Composition and Athletic Performance

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ClinicalTrials.gov Identifier: NCT02819219
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Collaborator:
VDF FutureCeuticals Inc.
Information provided by (Responsible Party):
MusclePharm Sports Science Institute

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Supplemental Other: Exercise Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Effects of ElevATP on Body Composition and Athletic Performance
Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Placebo Comparator: Placebo
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
participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.
Other Name: ElevATP, PurEnergy

Other: Exercise Intervention
Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.

Experimental: ElevATP
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
participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.
Other Name: ElevATP, PurEnergy

Other: Exercise Intervention
Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.

Experimental: ElevATP w/Caffeine
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
participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.
Other Name: ElevATP, PurEnergy

Other: Exercise Intervention
Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819219


Sponsors and Collaborators
MusclePharm Sports Science Institute
VDF FutureCeuticals Inc.
Investigators
Layout table for investigator information
Principal Investigator: jordan m joy, ms MusclePharm Sports Science Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MusclePharm Sports Science Institute
ClinicalTrials.gov Identifier: NCT02819219     History of Changes
Other Study ID Numbers: VDFMPSSI01
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The decision is not for the researchers to make and must consult with the funding agencies

Keywords provided by MusclePharm Sports Science Institute:
Dietary Supplements
Exercise

Additional relevant MeSH terms:
Layout table for MeSH terms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents