Effects of ElevATP on Body Composition and Athletic Performance

NCT ID: NCT02819219

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-12-31

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.

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

Keywords

Dietary Supplements; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Supplemental

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise Intervention

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Supplemental

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise Intervention

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Supplemental

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise Intervention

Intervention Type: OTHER

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

Interventions

Supplemental

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

Intervention Type: DIETARY_SUPPLEMENT

Exercise Intervention

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

Intervention Type: OTHER

Other Intervention Names

ElevATP, PurEnergy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VDF FutureCeuticals Inc.

INDUSTRY

Sponsor Role: collaborator

MusclePharm Sports Science Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jordan m joy, ms

Role: PRINCIPAL_INVESTIGATOR

MusclePharm Sports Science Institute

References

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.

Reference Type: DERIVED

PMID: 27430755 (View on PubMed)

Other Identifiers

VDFMPSSI01

Identifier Type: -

Identifier Source: org_study_id