Ineffective ErythropoiesisNCT02134119
Echinacea-based Supplement Does Not Improve Markers of Performance in Athletes
A study testing Echinacea-based dietary supplement in people with Ineffective Erythropoiesis, run by University of Georgia at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Ineffective Erythropoiesis
- What is being tested?
- Echinacea-based dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409
About this study
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.
Read the 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.
- Conditions
- Ineffective Erythropoiesis
- Being tested
- Echinacea-based dietary supplement, Placebo
- Keywords
- dietary supplement, endurance athletes, VO2max, red blood cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinacea-based dietary supplementDietary supplement
Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth
PlaceboDrug
Also called Sugar pill manufactured to mimic dietary supplement
Sugar pill manufactured to mimic dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Echinacea-based dietary supplement | Experimental | Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days Receives: Dietary Supplement: Echinacea-based dietary supplement |
| Sugar pill | Placebo comparator | Placebo given 8,000mg/day by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 Max
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.
Measured: 0-days (baseline)
VO2 Max
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.
Measured: 35-days
Secondary outcomes (15)
Hematological Measures - Red Blood Cells
as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 0 days (baseline)
Hematological Measures - Red Blood Cells
as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 14 days (mid-intervention)
Hematological Measures - Red Blood Cells
as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 35 days
Hematological Measures - Erythropoietin
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 0 days (baseline)
Hematological Measures - Erythropoietin
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 14 days (mid-intervention)
Hematological Measures - Erythropoietin
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 35 days
Hematological Measures - Ferritin
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 0 days (baseline)
Hematological Measures - Ferritin
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 14 days (mid-intervention)
Hematological Measures - Ferritin
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 35 days
Hematological Measures - Hematocrit
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 0 days (baseline)
Hematological Measures -Hematocrit
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 14 days (mid-intervention)
Hematological Measures - Hematocrit
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 35 days
Hematological Measures - Hemoglobin
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 0 days (baseline)
Hematological Measures - Hemoglobin
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 14 days (mid-intervention)
Hematological Measures - Hemoglobin
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ineffective ErythropoiesisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Cooper, University of Georgia
- Investigators
- Jamie A Cooper, Ph.D., Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134119
- Sponsor's protocol ID
- BRL-23C403
- Other IDs
- BRL-23C403
- Status last verified
- Nov 2016
- First submitted
- 2 May 2014
- Last updated
- 5 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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. doi: 10.1123/ijsnem.17.4.378.
PubMed 17962712
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echinacea-based Supplement Does Not Improve Markers of Performance in Athletes
- ClinicalTrials.gov ID
- NCT02134119
- Acronym / sponsor ID
- BRL-23C403
- Conditions
- Ineffective Erythropoiesis
- Keywords
- dietary supplement, endurance athletes, VO2max, red blood cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echinacea-based dietary supplement | Experimental | Dietary Supplement: Echinacea-based dietary supplementEchinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days |
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo given 8,000mg/day by mouth |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Echinacea-based dietary supplementEchinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth | Dietary supplement | Echinacea-based dietary supplement |
| PlaceboAlso: Sugar pill manufactured to mimic dietary supplementSugar pill manufactured to mimic dietary supplement | Drug | Sugar pill |
Primary outcome
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.
15 secondary outcomes
Hematological Measures - Red Blood Cells
Time frame: 0 days (baseline)
Hematological Measures - Red Blood Cells
Time frame: 14 days (mid-intervention)
Hematological Measures - Red Blood Cells
Time frame: 35 days
Hematological Measures - Erythropoietin
Time frame: 0 days (baseline)
Hematological Measures - Erythropoietin
Time frame: 14 days (mid-intervention)
Hematological Measures - Erythropoietin
Time frame: 35 days
Hematological Measures - Ferritin
Time frame: 0 days (baseline)
Hematological Measures - Ferritin
Time frame: 14 days (mid-intervention)
Hematological Measures - Ferritin
Time frame: 35 days
Hematological Measures - Hematocrit
Time frame: 0 days (baseline)
Hematological Measures -Hematocrit
Time frame: 14 days (mid-intervention)
Hematological Measures - Hematocrit
Time frame: 35 days
Hematological Measures - Hemoglobin
Time frame: 0 days (baseline)
Hematological Measures - Hemoglobin
Time frame: 14 days (mid-intervention)
Hematological Measures - Hemoglobin
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17962712Whitehead 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. doi: 10.1123/ijsnem.17.4.378.
- Individual participant dataSharing planned: No
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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.
Jamie A Cooper, Ph.D. principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echinacea-based dietary supplement in people with Ineffective Erythropoiesis, run by University of Georgia at 1 site in United States.
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 4 inclusion and 8 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
VO2 Max (time frame: 0-days (baseline)). The study lists 2 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 NCT02134119, 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 5 Jan 2017.