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

Ineffective Erythropoiesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134119
• Other study ID #: BRL-23C403
• Secondary ID: BRL-23C403
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: May 6, 2014
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Ineffective Erythropoiesis

Intervention

Dietary Supplement:
• Echinacea-based dietary supplement
Echinacea-based dietary supplement given at 4,000mg/day by mouth
• Echinacea-based dietary supplement
Echinacea-based dietary supplement given at 8,000mg/day by mouth

Drug:
• Placebo
Sugar pill manufactured to mimic echinacea-based dietary supplement

Locations

Country	Name	City	State
United States	Texas Tech University - Department of Nutritional Sciences	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 Max		35-days	No
Secondary	Hematological measures	as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)	35 days	No
Secondary	Hematological measures	as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)	35 days	No
Secondary	Hematological measures	as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)	35 days	No
Secondary	Hematological measures	as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)	35 days	No
Secondary	Hematological measures	as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)	35 days	No