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Echinacea-based Supplement Does Not Improve Markers of Performance in Athletes

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ClinicalTrials.gov Identifier: NCT02134119
Recruitment Status : Completed
First Posted : May 8, 2014
Results First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jamie Cooper, University of Georgia

Tracking Information
First Submitted Date  ICMJE May 2, 2014
First Posted Date  ICMJE May 8, 2014
Results First Submitted Date  ICMJE July 12, 2016
Results First Posted Date  ICMJE January 5, 2017
Last Update Posted Date January 5, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
  • VO2 Max [ Time Frame: 0-days (baseline) ]
    A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.
  • VO2 Max [ Time Frame: 35-days ]
    A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
VO2 Max [ Time Frame: 35-days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
  • Hematological Measures - Red Blood Cells [ Time Frame: 0 days (baseline) ]
    as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Red Blood Cells [ Time Frame: 14 days (mid-intervention) ]
    as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Red Blood Cells [ Time Frame: 35 days ]
    as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Erythropoietin [ Time Frame: 0 days (baseline) ]
    as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Erythropoietin [ Time Frame: 14 days (mid-intervention) ]
    as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Erythropoietin [ Time Frame: 35 days ]
    as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Ferritin [ Time Frame: 0 days (baseline) ]
    as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Ferritin [ Time Frame: 14 days (mid-intervention) ]
    as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Ferritin [ Time Frame: 35 days ]
    as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Hematocrit [ Time Frame: 0 days (baseline) ]
    as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures -Hematocrit [ Time Frame: 14 days (mid-intervention) ]
    as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Hematocrit [ Time Frame: 35 days ]
    as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Hemoglobin [ Time Frame: 0 days (baseline) ]
    as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Hemoglobin [ Time Frame: 14 days (mid-intervention) ]
    as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological Measures - Hemoglobin [ Time Frame: 35 days ]
    as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • Hematological measures [ Time Frame: 35 days ]
    as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological measures [ Time Frame: 35 days ]
    as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological measures [ Time Frame: 35 days ]
    as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological measures [ Time Frame: 35 days ]
    as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
  • Hematological measures [ Time Frame: 35 days ]
    as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Echinacea-based Supplement Does Not Improve Markers of Performance in Athletes
Official Title  ICMJE Echinacea-based Supplement Does Not Improve Markers of Performance in Athletes
Brief Summary The purpose of this study was three-fold. We wanted to (1) determine if supplementation with an echinacea-based dietary supplement (ECH) would increase several blood parameters that could affect oxygen carrying capacity in the body, (2) determine if ECH would increase VO2max in trained endurance athletes, and (3) examine the effectiveness of two different doses of the ECH on all outcome variables. We hypothesized that supplementation with ECH would increase oxygen carrying capacity (as measured by RBCs, EPO, ferritin, hemoglobin (Hb), and hematocrit (Hct) levels), improve VO2max, and that the maximum dose would be most effective at increasing these outcomes.
Detailed Description

The supplement industry is a multi-billion dollar industry with many of the products targeted toward athletes and achieving optimal performance. Historically, endurance athletes have used a number of methods to try to increase erythrocyte (red blood cell-RBC) production in attempts to boost oxygen carrying capacity and perform better during aerobic exercise. A number of growth factors in the body can stimulate RBC production including erythropoietin (EPO). EPO is the primary growth factor that promotes the formation and release of RBCs from bone marrow. Although EPO itself is a banned substance, supplement companies have sought other means by which they can increase EPO production in the body in order to stimulate RBC synthesis. One natural product toted to stimulate EPO production is Echinacea and can be found in the product EPO-Boost™. Our global hypothesis is that supplementation of EPO-Boost™ will be an effective way to increase oxygen carrying capacity and improve maximal oxygen consumption in adult endurance athletes.

We will test whether EPO-Boost™ affects EPO levels, a number of blood parameters, and VO2max (maximal aerobic capacity) by recruiting 40 trained endurance athletes (20 males and 20 females). To be included, subjects must already be performing aerobic exercise at least 4 days per week for a minimum of one hour each day. Participants will be randomly assigned (within gender) to either the placebo (n=20) or supplement group (n=20). A 25% dropout rate may be expected in both genders, therefore we are recruiting a subject number of 40 participants to ensure that at least 30 subjects will complete the study. All participants will be blinded as to whether they are receiving the placebo or the supplement. Participants will report to the Human Nutrition Lab (HNL) and the Exercise Physiology Lab for baseline testing. Height, body weight, body composition, and blood samples will be obtained. Participants will then answer questions regarding their current and usual exercise patterns. These questions will address the type, frequency, duration, and intensity of exercise. Finally, participants will perform a VO2max test in the Exercise Physiology Lab. After baseline testing the participants will be given a supply of either EPO-Boost™ or placebo along with extra capsules. The subjects will not know whether they are receiving the product or the placebo. Participants will also be asked to consume a multivitamin pill daily for the entire 35-day intervention period. Finally, participants will be asked to keep an exercise log during the 35-day intervention documenting type, duration, intensity, and days of exercise in order for research personnel to ensure that exercise training is not changing. The capsule and exercise logs will be collected at days 14 and 35.

Blood collected during all 3 visits will be analyzed for EPO, ferritin, RBCs, white blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. We will assess changes in blood parameters and VO2max to determine whether 35 days of EPO-Boost™ supplementation improves blood parameters or maximal aerobic capacity compared to placebo controls.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Ineffective Erythropoiesis
Intervention  ICMJE
  • Dietary Supplement: Echinacea-based dietary supplement
    Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth
  • Drug: Placebo
    Sugar pill manufactured to mimic dietary supplement
    Other Name: Sugar pill manufactured to mimic dietary supplement
Study Arms  ICMJE
  • Experimental: Echinacea-based dietary supplement
    Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
    Intervention: Dietary Supplement: Echinacea-based dietary supplement
  • Placebo Comparator: Sugar pill
    Placebo given 8,000mg/day by mouth
    Intervention: Drug: Placebo
Publications * Whitehead MT, Martin TD, Scheett TP, Webster MJ. The effect of 4 wk of oral echinacea supplementation on serum erythropoietin and indices of erythropoietic status. Int J Sport Nutr Exerc Metab. 2007 Aug;17(4):378-90.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2014)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female endurance athletes between the ages of 18-44
  • Normal body mass index (BMI) between 18.5-24.9kg/m2.
  • Individuals must currently be performing aerobic exercise at least 4 days per week for a minimum of 60 minutes at each session.
  • They must also be willing to maintain their current training regimen through the course of the study.

Exclusion Criteria:

  • Any changes in altitude during the study (where they are living or training)
  • Recent altitude training or use of a hypobaric chamber (within the last 6 months)
  • Any other supplements or ergogenic aids (excluding multivitamins)
  • Any participant who will be changing their current exercise training program during the study (includes changes in volume, frequency, or intensity)
  • If any participant is pregnant, breastfeeding, or planning to become pregnant before this study would finish
  • Any blood transfusions or blood donation in the past 16 weeks
  • Any chronic diseases such as cardiovascular disease, renal disease, or diabetes
  • Any condition that affects their ability to perform maximal exercise
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134119
Other Study ID Numbers  ICMJE BRL-23C403
BRL-23C403 ( Other Grant/Funding Number: Biomedical Research Laboratories, (grant #23C403) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jamie Cooper, University of Georgia
Study Sponsor  ICMJE University of Georgia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamie A Cooper, Ph.D. Texas Tech University
PRS Account University of Georgia
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP