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| Name | Class |
|---|---|
| VDF FutureCeuticals Inc. | INDUSTRY |
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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.
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):
Bioelectric Impedance Analysis and Spectroscopy (BIA/BIS) determined (weeks 0, 4, 8, 10, 12):
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive a flavored water placebo supplement. Part of the supplemental intervention. This, and all groups, simultaneously took part in the exercise intervention. |
|
| ElevATP | Experimental | 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. |
|
| ElevATP w/Caffeine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental | Dietary Supplement | participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jordan m joy, ms | MusclePharm Sports Science Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27430755 | Derived | 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. |
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The decision is not for the researchers to make and must consult with the funding agencies
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Exercise Intervention | Other | Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention. |
|
Measured by vertec.
| measure at 0, 4, 8, 10, and 12 weeks of the intervention |
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 |