HealthyNCT02819219
Effects of ElevATP on Body Composition and Athletic Performance
A study testing Supplemental and Exercise Intervention in people with Healthy, run by MusclePharm Sports Science Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Supplemental and Exercise Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Supplemental, Exercise Intervention
- Keywords
- Dietary Supplements, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementalDietary supplement
Also called ElevATP, PurEnergy
participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.
Exercise InterventionOther
Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Supplemental; Other: 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. Receives: Dietary Supplement: Supplemental; Other: 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. Receives: Dietary Supplement: Supplemental; Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Fat (in kilograms)
Measured by dual emissions x-ray absorptiometry (DEXA), bioelectric impedance analysis (BIA), and bioelectric impedance spectroscopy (BIS)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: measure at 0, 4, 8, 10, and 12 weeks of the intervention
Change in vertical jump height (in centimeters)
Measured by vertec.
Measured: measure at 0, 4, 8, 10, and 12 weeks of the intervention
Secondary outcomes (44)
Change in white blood cells (number of cells per unit of blood volume)
measured by third party, Laboratory Corporation of America (LabCorp)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in hemoglobin (grams per deciliter)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in mean corpuscular hemoglobin concentration (grams per deciliter)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in hematocrit (%)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in red blood cell distribution width (%)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in mean corpuscular volume (fL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in mean corpuscular hemoglobin (pg)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in serum glucose (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in blood urea nitrogen (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in creatinine (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in calcium (mg/dL)
measured by third party, LabCorp
Measured: 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
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in total protein (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in albumin (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in globulin (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in bilirubin (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in total cholesterol (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in triglycerides (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in high-density lipoprotein (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in low-density lipoprotein (mg/dL)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in very low density lipoprotein (mg/dL)
measured by third party, LabCorp
Measured: 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
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in serum sodium (mmol/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in serum potassium (mmol/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in serum chloride (mmol/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in serum carbon dioxide (mmol/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in aspartate aminotransferase (IU/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in alanine aminotransferase (IU/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in alkaline phosphatase (IU/L)
measured by third party, LabCorp
Measured: measure at 0, 8, and 12 weeks of the intervention
Change in Irisin (pg/mL)
measured by enzyme-linked immunosorbent assay
Measured: measure at 0, 4, 8, and 12 weeks of the intervention
Change in Interleukin-6 (pg/mL)
measured by enzyme-linked immunosorbent assay
Measured: measure at 0, 4, 8, and 12 weeks of the intervention
Change in interleukin-15 (pg/mL)
measured by enzyme-linked immunosorbent assay
Measured: 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
Measured: measure at 0, 4, 8, and 12 weeks of the intervention
Change in myonectin (pg/mL)
measured by enzyme-linked immunosorbent assay
Measured: measure at 0, 4, 8, and 12 weeks of the intervention
Change in cortisol (pg/mL)
measured by enzyme-linked immunosorbent assay
Measured: measure at 0, 4, 8, and 12 weeks of the intervention
Change in c-reactive protein (pg/mL)
measured by enzyme-linked immunosorbent assay
Measured: 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
Measured: measure at 0, 4, 8, and 12 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- MusclePharm Sports Science Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VDF FutureCeuticals Inc.
- Responsible party
- Sponsor
- Investigators
- jordan m joy, ms, Principal investigator, MusclePharm Sports Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819219
- Sponsor's protocol ID
- VDFMPSSI01
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The decision is not for the researchers to make and must consult with the funding agencies
Publications
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.
PubMed 27430755
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ElevATP on Body Composition and Athletic Performance
- ClinicalTrials.gov ID
- NCT02819219
- Acronym / sponsor ID
- VDFMPSSI01
- Conditions
- Healthy
- Keywords
- Dietary Supplements, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- MusclePharm Sports Science InstituteIndustry (pharma, biotech, devices)
- Collaborators
- VDF FutureCeuticals Inc.
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Supplemental, Other: Exercise InterventionParticipants 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 | Dietary Supplement: Supplemental, Other: Exercise InterventionParticipants 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 | Dietary Supplement: Supplemental, Other: Exercise InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementalAlso: ElevATP, PurEnergyparticipants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins. | Dietary supplement | ElevATP, ElevATP w/Caffeine, Placebo |
| Exercise InterventionConcurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention. | Other | ElevATP, ElevATP w/Caffeine, Placebo |
Primary outcome
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)
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)
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)
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.
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.
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
Change in vertical jump height (in centimeters)
Time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention
Measured by vertec.
44 secondary outcomes
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
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
Change in platelets (number of cells per unit of blood volume)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in neutrophils (number of cells per unit of blood volume)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in eosinophils (number of cells per unit of blood volume)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in basophils (number of cells per unit of blood volume)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in monocytes (number of cells per unit of blood volume)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in lymphocytes. (number of cells per unit of blood volume)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in hemoglobin (grams per deciliter)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in mean corpuscular hemoglobin concentration (grams per deciliter)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in hematocrit (%)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in red blood cell distribution width (%)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in mean corpuscular volume (fL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in mean corpuscular hemoglobin (pg)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in serum glucose (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in blood urea nitrogen (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in creatinine (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in calcium (mg/dL)
Time frame: 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)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in total protein (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in albumin (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in globulin (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in bilirubin (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in total cholesterol (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in triglycerides (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in high-density lipoprotein (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in low-density lipoprotein (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in very low density lipoprotein (mg/dL)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in estimated glomerular filtration rate (mL/min/1.73)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in serum sodium (mmol/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in serum potassium (mmol/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in serum chloride (mmol/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in serum carbon dioxide (mmol/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in aspartate aminotransferase (IU/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in alanine aminotransferase (IU/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in alkaline phosphatase (IU/L)
Time frame: measure at 0, 8, and 12 weeks of the intervention
Change in Irisin (pg/mL)
Time frame: measure at 0, 4, 8, and 12 weeks of the intervention
Change in Interleukin-6 (pg/mL)
Time frame: measure at 0, 4, 8, and 12 weeks of the intervention
Change in interleukin-15 (pg/mL)
Time frame: measure at 0, 4, 8, and 12 weeks of the intervention
Change in fibroblast growth factor-21 (pg/mL)
Time frame: measure at 0, 4, 8, and 12 weeks of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Derived from this study: PubMed 27430755Joy 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.
- Individual participant dataSharing planned: Undecided. The decision is not for the researchers to make and must consult with the funding agencies
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Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jordan m joy, ms principal investigator
MusclePharm Sports Science Institute
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental and Exercise Intervention in people with Healthy, run by MusclePharm Sports Science Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Fat (in kilograms) (time frame: measure at 0, 4, 8, 10, and 12 weeks of the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016; AzTrials last refreshed its copy on 30 Oct 2026.