NCT02819219

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

June 22, 2016

Last Update Submit

June 27, 2016

Conditions

Keywords

Dietary SupplementsExercise

Outcome Measures

Primary Outcomes (7)

  • 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)

    Measured by vertec.

    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)

    measure at 0, 8, and 12 weeks of the intervention

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

    measure at 0, 8, and 12 weeks of the intervention

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

    measure at 0, 8, and 12 weeks of the intervention

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

    measure at 0, 8, and 12 weeks of the intervention

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

    measure at 0, 8, and 12 weeks of the intervention

  • +39 more secondary outcomes

Study Arms (3)

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.

Dietary Supplement: SupplementalOther: 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.

Dietary Supplement: SupplementalOther: 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.

Dietary Supplement: SupplementalOther: Exercise Intervention

Interventions

SupplementalDIETARY_SUPPLEMENT

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

Also known as: ElevATP, PurEnergy
ElevATPElevATP w/CaffeinePlacebo

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

ElevATPElevATP w/CaffeinePlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • jordan m joy, ms

    MusclePharm Sports Science Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 30, 2016

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 30, 2016

Record last verified: 2016-06