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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02134119
Enrollment
45
Registered
2014-05-08
Start date
2012-01-31
Completion date
2013-07-31
Last updated
2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ineffective Erythropoiesis

Keywords

dietary supplement, endurance athletes, VO2max, red blood cells

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.

Interventions

DIETARY_SUPPLEMENTEchinacea-based dietary supplement

Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth

DRUGPlacebo

Sugar pill manufactured to mimic dietary supplement

Sponsors

University of Georgia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
VO2 Max0-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.

Secondary

MeasureTime frameDescription
Hematological Measures - Erythropoietin0 days (baseline)as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Hematological Measures - Ferritin0 days (baseline)as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Hematological Measures - Red Blood Cells0 days (baseline)as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Hematological Measures -Hematocrit14 days (mid-intervention)as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Hematological Measures - Hemoglobin0 days (baseline)as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Hematological Measures - Hematocrit0 days (baseline)as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)

Countries

United States

Participant flow

Participants by arm

ArmCount
Echinacea-based Dietary Supplement
Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth
30
Sugar Pill
Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
15
Total45

Baseline characteristics

CharacteristicEchinacea-based Dietary SupplementSugar PillTotal
Age, Continuous25.6 years
STANDARD_DEVIATION 7.6
29.9 years
STANDARD_DEVIATION 7.7
27.0 years
STANDARD_DEVIATION 7.8
Gender
Female
8 Participants7 Participants15 Participants
Gender
Male
22 Participants8 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 15
serious
Total, serious adverse events
0 / 300 / 15

Outcome results

Primary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementVO2 Max55.1 ml/kg/minStandard Deviation 6.6
Sugar PillVO2 Max56.7 ml/kg/minStandard Deviation 6.7
Primary

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

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementVO2 Max55.6 ml/kg/minStandard Deviation 7.6
Sugar PillVO2 Max57.8 ml/kg/minStandard Deviation 8.3
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Erythropoietin7.1 mU/mLStandard Deviation 2.9
Sugar PillHematological Measures - Erythropoietin9.8 mU/mLStandard Deviation 2.2
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Erythropoietin7.3 mU/mLStandard Deviation 2.9
Sugar PillHematological Measures - Erythropoietin9.6 mU/mLStandard Deviation 2.5
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Erythropoietin7.2 mU/mLStandard Deviation 2.7
Sugar PillHematological Measures - Erythropoietin9.7 mU/mLStandard Deviation 3.1
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Ferritin52.4 ng/mLStandard Deviation 47.3
Sugar PillHematological Measures - Ferritin69.8 ng/mLStandard Deviation 70.7
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Ferritin50.6 ng/mLStandard Deviation 46.2
Sugar PillHematological Measures - Ferritin59.4 ng/mLStandard Deviation 52
Secondary

Hematological Measures - Ferritin

as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)

Time frame: 35 days

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Ferritin54.0 ng/mLStandard Deviation 41
Sugar PillHematological Measures - Ferritin51.7 ng/mLStandard Deviation 45.7
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures -Hematocrit41.5 percent of red blood cells in bloodStandard Deviation 3.2
Sugar PillHematological Measures -Hematocrit43.0 percent of red blood cells in bloodStandard Deviation 3.6
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Hematocrit41.7 percent of red blood cells in bloodStandard Deviation 3.4
Sugar PillHematological Measures - Hematocrit43.1 percent of red blood cells in bloodStandard Deviation 3.5
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Hematocrit44.5 percent of red blood cells in bloodStandard Deviation 3.1
Sugar PillHematological Measures - Hematocrit43.2 percent of red blood cells in bloodStandard Deviation 3.6
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Hemoglobin14.0 g/dLStandard Deviation 1.2
Sugar PillHematological Measures - Hemoglobin14.7 g/dLStandard Deviation 1.2
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Hemoglobin13.9 g/dLStandard Deviation 1.1
Sugar PillHematological Measures - Hemoglobin14.6 g/dLStandard Deviation 1.5
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Hemoglobin14.9 g/dLStandard Deviation 1.2
Sugar PillHematological Measures - Hemoglobin14.5 g/dLStandard Deviation 1.3
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Red Blood Cells4.6 M/uLStandard Deviation 0.6
Sugar PillHematological Measures - Red Blood Cells4.6 M/uLStandard Deviation 0.4
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Red Blood Cells4.6 M/uLStandard Deviation 0.5
Sugar PillHematological Measures - Red Blood Cells4.6 M/uLStandard Deviation 0.45
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Echinacea-based Dietary SupplementHematological Measures - Red Blood Cells4.92 M/uLStandard Deviation 0.6
Sugar PillHematological Measures - Red Blood Cells4.6 M/uLStandard Deviation 0.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026