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Trial record 4 of 27 for:    Echinacea

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

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ClinicalTrials.gov Identifier: NCT02134119
Recruitment Status : Completed
First Posted : May 8, 2014
Results First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jamie Cooper, University of Georgia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition Ineffective Erythropoiesis
Interventions Dietary Supplement: Echinacea-based dietary supplement
Drug: Placebo
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Period Title: Overall Study
Started 30 15
Completed 30 15
Not Completed 0 0
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill Total
Hide Arm/Group Description

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Total of all reporting groups
Overall Number of Baseline Participants 30 15 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 15 participants 45 participants
25.6  (7.6) 29.9  (7.7) 27.0  (7.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 15 participants 45 participants
Female
8
  26.7%
7
  46.7%
15
  33.3%
Male
22
  73.3%
8
  53.3%
30
  66.7%
1.Primary Outcome
Title VO2 Max
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
55.1  (6.6) 56.7  (6.7)
2.Primary Outcome
Title VO2 Max
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
55.6  (7.6) 57.8  (8.3)
3.Secondary Outcome
Title Hematological Measures - Red Blood Cells
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: M/uL
4.6  (0.6) 4.6  (0.4)
4.Secondary Outcome
Title Hematological Measures - Red Blood Cells
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: M/uL
4.6  (0.5) 4.6  (0.45)
5.Secondary Outcome
Title Hematological Measures - Red Blood Cells
Hide Description as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: M/uL
4.92  (0.6) 4.6  (0.4)
6.Secondary Outcome
Title Hematological Measures - Erythropoietin
Hide Description as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 0 days (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: mU/mL
7.2  (2.7) 9.7  (3.1)
7.Secondary Outcome
Title Hematological Measures - Erythropoietin
Hide Description as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 14 days (mid-intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: mU/mL
7.3  (2.9) 9.6  (2.5)
8.Secondary Outcome
Title Hematological Measures - Erythropoietin
Hide Description as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: mU/mL
7.1  (2.9) 9.8  (2.2)
9.Secondary Outcome
Title Hematological Measures - Ferritin
Hide Description as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 0 days (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
52.4  (47.3) 69.8  (70.7)
10.Secondary Outcome
Title Hematological Measures - Ferritin
Hide Description as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 14 days (mid-intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
50.6  (46.2) 59.4  (52.0)
11.Secondary Outcome
Title Hematological Measures - Ferritin
Hide Description as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
54.0  (41.0) 51.7  (45.7)
12.Secondary Outcome
Title Hematological Measures - Hematocrit
Hide Description as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 0 days (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: percent of red blood cells in blood
41.7  (3.4) 43.1  (3.5)
13.Secondary Outcome
Title Hematological Measures -Hematocrit
Hide Description as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 14 days (mid-intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: percent of red blood cells in blood
41.5  (3.2) 43.0  (3.6)
14.Secondary Outcome
Title Hematological Measures - Hematocrit
Hide Description as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: percent of red blood cells in blood
44.5  (3.1) 43.2  (3.6)
15.Secondary Outcome
Title Hematological Measures - Hemoglobin
Hide Description as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 0 days (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: g/dL
14.0  (1.2) 14.7  (1.2)
16.Secondary Outcome
Title Hematological Measures - Hemoglobin
Hide Description as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 14 days (mid-intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: g/dL
13.9  (1.1) 14.6  (1.5)
17.Secondary Outcome
Title Hematological Measures - Hemoglobin
Hide Description as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)
Time Frame 35 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description:

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: g/dL
14.9  (1.2) 14.5  (1.3)
Time Frame 35 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Echinacea-based Dietary Supplement Sugar Pill
Hide Arm/Group Description

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

Placebo given 8,000mg/day by mouth

Placebo: Sugar pill manufactured to mimic dietary supplement

All-Cause Mortality
Echinacea-based Dietary Supplement Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Echinacea-based Dietary Supplement Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Echinacea-based Dietary Supplement Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/15 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jamie Cooper
Organization: University of Georgia
Phone: 7065424903
Responsible Party: Jamie Cooper, University of Georgia
ClinicalTrials.gov Identifier: NCT02134119     History of Changes
Other Study ID Numbers: BRL-23C403
BRL-23C403 ( Other Grant/Funding Number: Biomedical Research Laboratories, (grant #23C403) )
First Submitted: May 2, 2014
First Posted: May 8, 2014
Results First Submitted: July 12, 2016
Results First Posted: January 5, 2017
Last Update Posted: January 5, 2017