- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07225413
Short-Term Rhodiola Rosea for Anaerobic Performance and Cognitive Function in Resistance-Trained Adults
Dose-Response Effects of Short-Term *Rhodiola Rosea* on Anaerobic Performance and Cognitive Function in Resistance-Trained Adults: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Study Overview
Status
Conditions
Detailed Description
Rationale: Rhodiola rosea is an adaptogenic plant extract that has shown modest, context-dependent effects on perception of effort, cognition, and exercise performance. Prior studies suggest that benefits may be more evident with acute or short-term administration; however, the results are heterogeneous. This study employs a within-subject approach in resistance-trained adults to minimize between-person variability and investigate potential dose-response effects over a short time frame.
Design overview: After screening and a familiarization visit, each participant completes four 7-day periods: (1) no-capsule control, (2) placebo, (3) low-dose RR, and (4) high-dose RR. Capsule periods are randomized and double-blind; the no-capsule control precedes capsule periods to avoid carryover of expectancy. Study staff, participants, and outcome assessors are blinded during capsule periods. On day 7 of each period, participants attend a single testing visit conducted under standardized conditions (time of day, pre-test instructions). Short-latency effects are targeted by scheduling capsule ingestion approximately 60 minutes before testing during capsule periods.
Intervention: Low- and high-dose RR are provided in identical-appearing capsules. Placebo capsules contain inert filler. Product identity, dose, and lot information are recorded in the Intervention section of the record. Capsule count and participant logs monitor adherence.
Standardization and compliance: Participants are asked to maintain their habitual training and diet and to refrain from using additional ergogenic aids for a period of 7 days. They record total energy and macronutrients for the three days before each testing day. Testing sessions follow a consistent order of tasks established during the familiarization phase. Resting vital signs are obtained after a seated rest; post-exercise measures are obtained 1 minute after completion of designated tasks.
Population: Resistance-trained adults (men and women) who meet eligibility criteria and provide informed consent. Additional eligibility details are specified in the Eligibility section of the record. The female hormonal status/menstrual phases are documented when available to aid in interpretation.
Data handling and analysis (overview): The primary analyses compare conditions within participants using linear mixed-effects models, with participant as a random effect and fixed terms for condition and period. Additional prespecified covariates (e.g., sex, pre-visit dietary intake) may also be included. Order and carryover are evaluated as appropriate. Missing data are handled using model-based methods consistent with the statistical plan.
Safety: Adverse events are monitored throughout each period, with procedures for reporting to the IRB per institutional policy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Jacksonville, Alabama, United States, 36265
- Exercise Physiology and Nutrition Laboratory (EPNL) at Jacksonville State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults 18-40 years old
- ≥2 years of consistent resistance training, including bench press and leg press/squat
- Able to complete all four 7-day conditions and Day-7 testing in a crossover design
- Willing to abstain from other performance supplements during the study
- Provided written informed consent
Exclusion Criteria:
- Diagnosed metabolic, cardiovascular, or thyroid disorders
- Cardiac arrhythmias
- Current prescription drugs with possible cardiovascular or neurocognitive effects
- Smoking
- Known or suspected sensitivity to Rhodiola rosea
- Regular alcohol intake >12 drinks/week
- Recent musculoskeletal injury that could limit resistance-exercise testing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No-Capsule Control
Participants complete a 7-day control period during which no capsules are administered.
On day 7 they report to the lab for testing (bench press and leg press 1RM, third set to failure at 60% 1RM, Tendo power, 30-s Wingate, and Stroop Color-Word Test), plus HR/BP and RPE.
This arm is always completed first to establish baseline performance.
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Placebo Comparator: Placebo
Participants ingest placebo capsules once daily for 7 days.
On day 7, ~60 minutes after the final dose, they complete the same performance and cognitive testing battery (resistance exercises, Wingate, Stroop, HR/BP, RPE).
This arm controls for expectancy and capsule intake.
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Participants will ingest matching placebo capsules once daily for 7 days.
On day 7, ~60 minutes after capsule ingestion, they will complete the full testing battery.
This intervention controls for expectancy, capsule handling, and timing.
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Experimental: Low-Dose Rhodiola rosea
Participants ingest low-dose Rhodiola rosea (e.g., 200 mg/day) for 7 days.
On day 7, ~60 minutes after dosing, they complete the laboratory testing session (bench/leg press 1RM and 60% to failure, Tendo power, 30-s Wingate, Stroop test, HR/BP, RPE) to determine whether short-term low-dose RR improves strength, muscular endurance, anaerobic performance, or executive function relative to control and placebo.
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Participants will ingest a low-dose Rhodiola rosea extract (≈approximately 200 mg/day) once daily for 7 consecutive days.
On day 7, ~60 minutes after the final dose, they will complete the exercise and cognitive testing battery (bench press, leg press, set to failure at 60% 1RM, Tendo power, 30-s Wingate, Stroop test, HR/BP, RPE).
This intervention is used to determine whether short-term, lower-dose RR improves resistance performance and executive function compared with placebo and control.
Other Names:
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Experimental: High-Dose Rhodiola rosea
Participants ingest high-dose Rhodiola rosea (e.g., 1,500 mg/day) for 7 days.
On day 7, ~60 minutes after dosing, they perform the identical performance and cognitive testing battery.
This arm allows for comparison of a higher RR dose with low-dose, placebo, and control groups to assess dose-response effects on resistance performance and Stroop outcomes.
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Participants will ingest a high-dose Rhodiola rosea extract (≈approximately 1,500 mg/day) once daily for 7 consecutive days.
On day 7, ~60 minutes after the final dose, they will complete the same performance and cognitive testing battery.
This arm allows dose-response comparison with the low-dose RR, placebo, and no-capsule control conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Load volume (kg) during 3rd set to failure at 60% 1RM
Time Frame: Day 7 of each 7-day period
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Participants performed bench presses and leg presses at 60% of their familiarization 1RM.
On the 3rd set, they lifted to volitional failure; load volume was calculated as load (kg) × repetitions.
Values after administration of low- and high-dose Rhodiola rosea were compared with those of the placebo and control groups.
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Day 7 of each 7-day period
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Wingate anaerobic test peak power
Time Frame: Day 7 of each 7-day period
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Participants completed a 30-s Wingate test on a cycle ergometer; peak power (W) was recorded.
Values after low- and high-dose Rhodiola rosea were compared with those of the placebo and control to assess the effects on anaerobic performance.
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Day 7 of each 7-day period
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Executive function (Stroop Color-Word Test)
Time Frame: Day 7 of each 7-day period
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The paper-and-pencil Stroop Color-Word Test is administered (Word, Color, and Color-Word, 45 s each).
The total number of correct responses across the three sections is recorded.
Higher scores indicate better executive control.
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Day 7 of each 7-day period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Readiness to Perform (Visual Analog Scale, 0-100 mm)
Time Frame: Day 7 of each 7-day period
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Participants rated six items before testing on a 0-100 mm line anchored 0 = strongly disagree (worse) and 100 = strongly agree (better): (1) I slept well last night; (2) I am looking forward to today's workout; (3) I am optimistic about my future performance; (4) I feel vigorous and energetic; (5) My appetite is great; (6) I have little muscle soreness.
Scores were recorded in millimeters; higher values indicate better readiness (greater agreement).
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Day 7 of each 7-day period
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Rating of Perceived Exertion (RPE) after resistance exercise
Time Frame: Day 7 of each 7-day period
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RPE is recorded 1 minute after the 3rd set of bench press and leg press using the Borg 6-20 scale.
Higher values indicate greater perceived exertion.
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Day 7 of each 7-day period
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Resting Heart Rate
Time Frame: Day 7 of each 7-day period
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Seated/resting heart rate measured before testing.
Unit: beats per minute (bpm).
Higher values indicate higher HR.
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Day 7 of each 7-day period
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1-Minute Post-Exercise Heart Rate
Time Frame: Day 7 of each 7 days (1-min post-bench press; 1-min post-leg press; 1-min post-Wingate).
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Heart rate was measured 60 s after completion of each exercise bout (bench press, leg press, Wingate).
Unit: beats per minute (bpm).
Higher values indicate higher HR.
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Day 7 of each 7 days (1-min post-bench press; 1-min post-leg press; 1-min post-Wingate).
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Resting Systolic Blood Pressure
Time Frame: Day 7 of each 7 days (pre-test).
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Seated/resting SBP measured before testing using an automated oscillometric device per manufacturer guidelines.
Unit: mmHg.
Higher values indicate higher SBP.
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Day 7 of each 7 days (pre-test).
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Resting Diastolic Blood Pressure
Time Frame: Day 7 of each 7 days (pre-test).
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Seated/resting DBP measured before testing using an automated oscillometric device per manufacturer guidelines.
Unit: mmHg.
Higher values indicate higher DBP.
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Day 7 of each 7 days (pre-test).
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1-Minute Post-Exercise Systolic Blood Pressure
Time Frame: Day 7 of each 7 days (1-min post-bench press; 1-min post-leg press; 1-min post-Wingate).
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SBP was measured 60 s after completion of each exercise bout (bench press, leg press, Wingate).
Unit: mmHg.
Higher values indicate higher SBP.
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Day 7 of each 7 days (1-min post-bench press; 1-min post-leg press; 1-min post-Wingate).
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1-Minute Post-Exercise Diastolic Blood Pressure
Time Frame: Day 7 of each 7 days (1-min post-bench press; 1-min post-leg press; 1-min post-Wingate).
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DBP was measured 60 s after completion of each exercise bout (bench press, leg press, Wingate).
Unit: mmHg.
Higher values indicate higher DBP.
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Day 7 of each 7 days (1-min post-bench press; 1-min post-leg press; 1-min post-Wingate).
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Adverse Events / Side-Effects-Frequency (0-5 Likert)
Time Frame: Day 7 of each 7 days (post-condition).
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Participants completed a side-effects questionnaire rating how often each symptom occurred using a 6-point scale (0 = none; 1 = minimal [1-2/week]; 2 = slight [3-4/week]; 3 = occasional [5-6/week]; 4 = frequent [7-8/week]; 5 = severe [≥9/week]).
Symptoms queried: dizziness, headache, fast/racing heart rate, heart skipping/palpitations, shortness of breath, nervousness, blurred vision, and "any other unusual/adverse effects."
Scores range 0-5 per item; higher = worse (more frequent).
Each item was analyzed separately; an optional composite frequency score (item mean) was also recorded.
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Day 7 of each 7 days (post-condition).
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Adverse Events / Side-Effects-Severity (0-5 Likert)
Time Frame: Day 7 of each 7 days (post-condition).
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Description: Using the same questionnaire, participants rated how severe each symptom was on a 6-point scale (0 = none; 1 = minimal; 2 = slight; 3 = moderate; 4 = severe; 5 = very severe).
Symptoms queried: dizziness, headache, fast/racing heart rate, heart skipping/palpitations, shortness of breath, nervousness, blurred vision, and "any other unusual/adverse effects."
Scores range 0-5 per item; higher = worse (more severe).
Each item was analyzed separately; an optional composite severity score (item mean) was also recorded.
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Day 7 of each 7 days (post-condition).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JSU-EPNL-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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