NCT02134119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 5, 2017

Completed
Last Updated

January 5, 2017

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

May 2, 2014

Results QC Date

July 12, 2016

Last Update Submit

November 8, 2016

Conditions

Ineffective Erythropoiesis

Keywords

dietary supplementendurance athletesVO2maxred blood cells

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    35-days

Secondary Outcomes (15)

  • Hematological Measures - Red Blood Cells

    0 days (baseline)

  • Hematological Measures - Red Blood Cells

    14 days (mid-intervention)

  • Hematological Measures - Red Blood Cells

    35 days

  • Hematological Measures - Erythropoietin

    0 days (baseline)

  • Hematological Measures - Erythropoietin

    14 days (mid-intervention)

  • +10 more secondary outcomes

Study Arms (2)

Echinacea-based dietary supplement

EXPERIMENTAL

Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days

Dietary Supplement: Echinacea-based dietary supplement

Sugar pill

PLACEBO COMPARATOR

Placebo given 8,000mg/day by mouth

Drug: Placebo

Interventions

Echinacea-based dietary supplementDIETARY_SUPPLEMENT

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

Echinacea-based dietary supplement
PlaceboDRUG

Sugar pill manufactured to mimic dietary supplement

Also known as: Sugar pill manufactured to mimic dietary supplement
Sugar pill

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Related 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. doi: 10.1123/ijsnem.17.4.378.

    PMID: 17962712BACKGROUND

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

A limitation is that we did not control for the menstrual cycle. Additionally, we used self-reported physical activity data which relies on accuracy of reporting.

Results Point of Contact

Title
Jamie Cooper
Organization
University of Georgia
jamie.cooper@uga.edu
7065424903

Study Officials

  • Jamie A Cooper, Ph.D.

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 8, 2014

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 5, 2017

Results First Posted

January 5, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)