An interventional study of Echinacea-based dietary supplement and Placebo in Ineffective Erythropoiesis, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-05.
Sponsored by University of Georgia · Not applicable and Interventional
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.
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.
University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days
Dietary Supplement: Echinacea-based dietary supplement
Placebo given 8,000mg/day by mouth
Drug: Placebo
Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth
Sugar pill manufactured to mimic dietary supplement
Also known as: Sugar pill manufactured to mimic dietary supplement
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.
Time frame: 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.
Time frame: 35-days
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)
Time frame: 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)
Time frame: 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)
Time frame: 35 days
Hematological Measures - Erythropoietin
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 0 days (baseline)
Hematological Measures - Erythropoietin
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 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)
Time frame: 35 days
Hematological Measures - Ferritin
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 0 days (baseline)
Hematological Measures - Ferritin
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 14 days (mid-intervention)
Hematological Measures - Ferritin
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 35 days
Hematological Measures - Hematocrit
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 0 days (baseline)
Hematological Measures -Hematocrit
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 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)
Time frame: 35 days
Hematological Measures - Hemoglobin
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 0 days (baseline)
Hematological Measures - Hemoglobin
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time frame: 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)
Time frame: 35 days
| Milestone | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Started | 30 | 15 |
| Completed | 30 | 15 |
| Not completed | 0 | 0 |
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.
| ml/kg/min | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| VO2 Max | 55.1 ± 6.6 | 56.7 ± 6.7 |
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.
| ml/kg/min | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| VO2 Max | 55.6 ± 7.6 | 57.8 ± 8.3 |
as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| M/uL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Red Blood Cells | 4.6 ± 0.6 | 4.6 ± 0.4 |
as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| M/uL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Red Blood Cells | 4.6 ± 0.5 | 4.6 ± 0.45 |
as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| M/uL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Red Blood Cells | 4.92 ± 0.6 | 4.6 ± 0.4 |
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| mU/mL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Erythropoietin | 7.2 ± 2.7 | 9.7 ± 3.1 |
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| mU/mL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Erythropoietin | 7.3 ± 2.9 | 9.6 ± 2.5 |
as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| mU/mL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Erythropoietin | 7.1 ± 2.9 | 9.8 ± 2.2 |
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| ng/mL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Ferritin | 52.4 ± 47.3 | 69.8 ± 70.7 |
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| ng/mL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Ferritin | 50.6 ± 46.2 | 59.4 ± 52.0 |
as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| ng/mL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Ferritin | 54.0 ± 41.0 | 51.7 ± 45.7 |
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| percent of red blood cells in blood | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Hematocrit | 41.7 ± 3.4 | 43.1 ± 3.5 |
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| percent of red blood cells in blood | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures -Hematocrit | 41.5 ± 3.2 | 43.0 ± 3.6 |
as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| percent of red blood cells in blood | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Hematocrit | 44.5 ± 3.1 | 43.2 ± 3.6 |
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| g/dL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Hemoglobin | 14.0 ± 1.2 | 14.7 ± 1.2 |
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| g/dL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Hemoglobin | 13.9 ± 1.1 | 14.6 ± 1.5 |
as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
| g/dL | Echinacea-based Dietary Supplement | Sugar Pill |
|---|---|---|
| Hematological Measures - Hemoglobin | 14.9 ± 1.2 | 14.5 ± 1.3 |
Collected over 35 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Echinacea-based Dietary Supplement | — | 0/30 (0%) | 0/30 (0%) |
| Sugar Pill | — | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Echinacea-based Dietary Supplement | Sugar Pill | Total |
|---|---|---|---|
| Mean | 25.6 ± 7.6 | 29.9 ± 7.7 | 27.0 ± 7.8 |
| Gender(Participants) | Echinacea-based Dietary Supplement | Sugar Pill | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 22 | 8 | 30 |
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