Trial Outcomes & Findings for Echinacea-based Supplement Does Not Improve Markers of Performance in Athletes (NCT NCT02134119)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

0-days (baseline)

Results posted on

2017-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	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	Sugar Pill Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Overall Study STARTED	30	15
Overall Study COMPLETED	30	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement	Total n=45 Participants Total of all reporting groups
Age, Continuous	25.6 years STANDARD_DEVIATION 7.6 • n=5 Participants	29.9 years STANDARD_DEVIATION 7.7 • n=7 Participants	27.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Gender Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants	8 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-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.

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
VO2 Max	55.1 ml/kg/min Standard Deviation 6.6	56.7 ml/kg/min Standard Deviation 6.7

PRIMARY outcome

Timeframe: 35-days

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.

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
VO2 Max	55.6 ml/kg/min Standard Deviation 7.6	57.8 ml/kg/min Standard Deviation 8.3

SECONDARY outcome

Timeframe: 0 days (baseline)

as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Red Blood Cells	4.6 M/uL Standard Deviation 0.6	4.6 M/uL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 14 days (mid-intervention)

as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Red Blood Cells	4.6 M/uL Standard Deviation 0.5	4.6 M/uL Standard Deviation 0.45

SECONDARY outcome

Timeframe: 35 days

as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Red Blood Cells	4.92 M/uL Standard Deviation 0.6	4.6 M/uL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 0 days (baseline)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Erythropoietin	7.2 mU/mL Standard Deviation 2.7	9.7 mU/mL Standard Deviation 3.1

SECONDARY outcome

Timeframe: 14 days (mid-intervention)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Erythropoietin	7.3 mU/mL Standard Deviation 2.9	9.6 mU/mL Standard Deviation 2.5

SECONDARY outcome

Timeframe: 35 days

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Erythropoietin	7.1 mU/mL Standard Deviation 2.9	9.8 mU/mL Standard Deviation 2.2

SECONDARY outcome

Timeframe: 0 days (baseline)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Ferritin	52.4 ng/mL Standard Deviation 47.3	69.8 ng/mL Standard Deviation 70.7

SECONDARY outcome

Timeframe: 14 days (mid-intervention)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Ferritin	50.6 ng/mL Standard Deviation 46.2	59.4 ng/mL Standard Deviation 52.0

SECONDARY outcome

Timeframe: 35 days

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Ferritin	54.0 ng/mL Standard Deviation 41.0	51.7 ng/mL Standard Deviation 45.7

SECONDARY outcome

Timeframe: 0 days (baseline)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Hematocrit	41.7 percent of red blood cells in blood Standard Deviation 3.4	43.1 percent of red blood cells in blood Standard Deviation 3.5

SECONDARY outcome

Timeframe: 14 days (mid-intervention)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures -Hematocrit	41.5 percent of red blood cells in blood Standard Deviation 3.2	43.0 percent of red blood cells in blood Standard Deviation 3.6

SECONDARY outcome

Timeframe: 35 days

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Hematocrit	44.5 percent of red blood cells in blood Standard Deviation 3.1	43.2 percent of red blood cells in blood Standard Deviation 3.6

SECONDARY outcome

Timeframe: 0 days (baseline)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Hemoglobin	14.0 g/dL Standard Deviation 1.2	14.7 g/dL Standard Deviation 1.2

SECONDARY outcome

Timeframe: 14 days (mid-intervention)

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Hemoglobin	13.9 g/dL Standard Deviation 1.1	14.6 g/dL Standard Deviation 1.5

SECONDARY outcome

Timeframe: 35 days

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

Outcome measures

Outcome measures
Measure	Echinacea-based Dietary Supplement n=30 Participants 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	Sugar Pill n=15 Participants Placebo given 8,000mg/day by mouth Placebo: Sugar pill manufactured to mimic dietary supplement
Hematological Measures - Hemoglobin	14.9 g/dL Standard Deviation 1.2	14.5 g/dL Standard Deviation 1.3

Adverse Events

Echinacea-based Dietary Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamie Cooper

University of Georgia

Phone: 7065424903

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place