- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07924020
Acute Effects of Rhodiola Rosea and Caffeine on Mean Propulsive Velocity Loss in Resistance Training (Rhocaf2)
The Acute Effects of 1,000 mg of Rhodiola Rosea and 3 mg/kg of Caffeine on Mean Propulsive Velocity Loss in Advanced Resistance-Trained Subjects: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
The goal of this clinical trial is to evaluate if combined acute supplementation with Rhodiola rosea and caffeine is superior to single-ingredient intake or placebo in attenuating neuromuscular fatigue in advanced resistance-trained subjects.
The main questions it aims to answer are:
Does combined supplementation attenuate mean propulsive velocity loss during heavy resistance exercise? Does combined supplementation reduce ratings of perceived exertion and increase repetitions performed to failure?
Researchers will compare four experimental conditions (placebo, caffeine alone, Rhodiola rosea alone, and combined supplementation) in a randomized crossover design to see if co-ingestion provides superior anti-fatigue benefits.
Participants will:
Complete a familiarization session to establish individual strength baselines. Attend 4 testing visits separated by a 72-hour washout period. Ingest the assigned treatment before testing. Perform a back squat fatigue protocol (3 sets at 70% 1RM) and complete perceptual evaluations.The goal of this clinical trial is to evaluate if combined acute supplementation with Rhodiola rosea and caffeine is superior to single-ingredient intake or placebo in attenuating neuromuscular fatigue in advanced resistance-trained subjects.
The main questions it aims to answer are:
Does combined supplementation attenuate mean propulsive velocity loss during heavy resistance exercise? Does combined supplementation reduce ratings of perceived exertion and increase repetitions performed to failure?
Researchers will compare four experimental conditions (placebo, caffeine alone, Rhodiola rosea alone, and combined supplementation) in a randomized crossover design to see if co-ingestion provides superior anti-fatigue benefits.
Participants will:
Complete a familiarization session to establish individual strength baselines. Attend 4 testing visits separated by a 72-hour washout period. Ingest the assigned treatment before testing. Perform a back squat fatigue protocol (3 sets at 70% 1RM) and complete perceptual evaluations.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
This study is a randomized, double-blind, placebo-controlled, four-arm crossover trial designed to investigate the acute neuromuscular and ergogenic effects of single and combined supplementation with Rhodiola rosea (1,000 mg) and caffeine (3 mg/kg) in advanced resistance-trained subjects.
Neuromuscular fatigue during heavy resistance training impairs movement velocity, power output, and overall volume performance. While caffeine is a central nervous system stimulant that enhances motor unit recruitment and reduces perceived exertion, Rhodiola rosea is an adaptogen proposed to modulate central monoamines and attenuate fatigue during high-intensity effort. This protocol evaluates whether co-ingestion provides a synergistic advantage over isolated administration or placebo in maintaining movement execution quality and accelerating acute recovery.
Study Procedures:
Familiarization Session: Prior to the experimental trials, participants complete a familiarization session to establish baseline measurements and estimate 1-repetition maximum (1RM) in the barbell back squat using a two-point load-velocity method (using loads corresponding to ~1.0 m/s and ~0.5 m/s) with a linear position transducer.
Experimental Trials (4 Visits): Participants complete four experimental testing visits in a randomized, counterbalanced order, separated by a 72-hour washout period.
During each of the 4 experimental visits, participants complete the following sequence:
Supplement Ingestion: Double-blind administration of the assigned treatment:
Rhodiola placebo consists of opaque cornstarch capsules. Caffeine placebo consists of a 60 mL liquid solution containing sweetener, 3 g of sugar, and 1 g of citric acid.
Active conditions consist of 1,000 mg of Rhodiola rosea and/or 3 mg/kg of caffeine.
Pre-Exercise Evaluation: Completion of baseline perceptual questionnaires. Velocity Determination: Identification of the exact load corresponding to a Mean Propulsive Velocity (MPV) of 1.0 ± 0.03 m/s in the back squat.
Acute Fatigue Protocol: Execution of 3 sets at 70% estimated 1RM in the back squat performed to muscular failure, recording total repetitions and velocity loss across sets.
Post-Fatigue Velocity Recovery: Re-assessment of MPV using the pre-determined 1.0 m/s load at exactly 1 minute and 2 minutes post-fatigue protocol to evaluate acute neuromuscular fatigue and velocity recovery.
Perceptual Evaluation: Rating of Perceived Exertion (RPE) recorded post-exercise.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: David Gomez Castillo, PhD Candidate
- Telefonszám: +52 2382091643
- E-mail: david.gomezcs@uanl.edu.mx
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Marina Medina Corrales, PhD
- Telefonszám: +52 8115358121
- E-mail: marina.medinacr@uanl.edu.mx
Tanulmányi helyek
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Nuevo León
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San Nicolás, Nuevo León, Mexikó, 66455
- Faculty of Sports Organization, Universidad Autonoma de Nuevo Leon
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Kapcsolatba lépni:
- Marina Medina Corrales, PhD
- Telefonszám: +528115358121
- E-mail: marina.medinacr@uanl.edu.mx
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-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Healthy males and females.
- Advanced resistance training experience (as defined by Santos et al., 2021): 1 to 3 years of consistent resistance training experience, demonstrating proper barbell back squat technique.
- Relative maximum strength (estimated 1RM back squat): Minimum of 150% of body mass for men, and 130% of body mass for women.
- Habitual caffeine consumers (e.g., daily intake via coffee, tea, sports gels, or energy drinks).
- Commitment to maintaining current nutritional habits and training routines throughout the study period.
- Ensured stable consumption of dietary supplements with cumulative effects (e.g., creatine, beta-alanine, nitrates, citrulline, betaine) for at least one month prior to and throughout the experimental protocol, with a commitment to not alter the dosage. Intake will be recorded and standardized.
- Availability to attend all scheduled evaluations.
- Provision of written informed consent validating full understanding of the study protocols.
Exclusion Criteria:
- Presence of cardiovascular diseases (e.g., arterial hypertension, arrhythmias) or metabolic disorders (e.g., type 1 or type 2 diabetes mellitus).
- At least one affirmative response on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
- History of anabolic steroid use (less than 4 years) or use of World Anti-Doping Agency (WADA) prohibited performance-enhancing substances.
- Consumption of supplements with acute ergogenic effects (e.g., coffee, energy drinks, pre-workout supplements) within 12 hours prior to testing sessions, or failure to comply with a minimum 4-hour fasting period prior to the experimental session. (Note: Subjects violating these criteria will have their session rescheduled).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Placebo Comparator: Placebo
Placebo condition consisting of opaque cornstarch capsules and a 60 mL placebo liquid solution. |
Opaque cornstarch capsules matching the active Rhodiola capsules. 60 mL liquid solution containing sweetener, 3 g of sugar, and 1 g of citric acid. |
|
Kísérleti: Caffeine
Single administration of caffeine alongside placebo capsules. |
Opaque cornstarch capsules matching the active Rhodiola capsules. 3 mg/kg of caffeine administered in a 60 mL liquid solution. |
|
Kísérleti: Rhodiola rosea
Single administration of Rhodiola rosea alongside placebo liquid solution. |
60 mL liquid solution containing sweetener, 3 g of sugar, and 1 g of citric acid. 1,000 mg of Rhodiola rosea administered in opaque capsules. |
|
Kísérleti: Rhodiola rosea + Caffeine
Combined administration of Rhodiola rosea and caffeine. |
3 mg/kg of caffeine administered in a 60 mL liquid solution. 1,000 mg of Rhodiola rosea administered in opaque capsules. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentage Loss in Mean Propulsive Velocity (MPV)
Időkeret: Baseline (pre-fatigue), 1 minute, and 2 minutes post-fatiguing exercise protocol, up to 2 weeks.
|
Percentage loss in mean propulsive velocity (MPV) following the fatiguing protocol. MPV is assessed during the barbell back squat using an individualized load corresponding to an initial velocity of 1.0 ± 0.03 m/s, recorded via a linear position transducer. Percentage loss is calculated relative to pre-fatigue baseline as: [(baseline MPV - post-fatigue MPV) / baseline MPV] × 100. The fatiguing protocol consists of 3 sets to failure at 70% 1RM. |
Baseline (pre-fatigue), 1 minute, and 2 minutes post-fatiguing exercise protocol, up to 2 weeks.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Total Number of Repetitions to Failure
Időkeret: Immediately upon completion of the fatiguing exercise protocol, up to 2 weeks
|
Cumulative number of successful repetitions completed across 3 sets at 70% 1RM performed to momentary muscular failure during the fatiguing protocol. Data are reported as the total number of repetitions completed per experimental condition. |
Immediately upon completion of the fatiguing exercise protocol, up to 2 weeks
|
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Rating of Perceived Exertion (RPE)
Időkeret: Immediately, 1 minute, and 2 minutes post-fatiguing exercise protocol, up to 2 weeks
|
Subjective perception of effort assessed using a standardized RPE scale immediately following the fatiguing protocol to quantify internal load. |
Immediately, 1 minute, and 2 minutes post-fatiguing exercise protocol, up to 2 weeks
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: José Raúl Hoyos Flores, PhD, Faculty of Sports Organization, Universidad Autonoma de Nuevo Leon
- Tanulmányi igazgató: Marina Medina Corrales, PhD, Faculty of Sports Organization, Universidad Autonoma de Nuevo Leon
- Tanulmányi szék: Myriam Zaraí García Dávila, PhD, Faculty of Sports Organization, Universidad Autonoma de Nuevo Leon
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CEIFOD 0125028
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD megosztási időkeret
Data will become available after publication of the main manuscript in a peer-reviewed journal and will remain accessible indefinitely.
IPD-megosztási hozzáférési feltételek
Data and supporting materials will be publicly accessible via the Open Science Framework (OSF) repository to any researcher interested in secondary or meta-analysis.
Az IPD megosztását támogató információ típusa
- ICF
- ANALYTIC_CODE
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