NCT06853600

Brief Summary

This document aims to provide information to request authorization to collect data on the effects of supplementation administered 30 minutes before resistance training on the number of repetitions, execution speed, and perceived effort for the bench press and bench pull exercises. To grant authorization, an informed consent form must be signed for the use of the information. If authorization is granted, personalized information will be provided by the professional requesting the consent. It is recommended to read this document beforehand and ask any questions necessary to understand the details. If desired, the document can be taken for consultation with others, allowing ample time to make a decision. The decision is entirely voluntary. It is possible to decline authorization for the use of personal and/or health data without affecting the relationship with the professional requesting the consent or healthcare services. PURPOSE OF THIS REQUEST Participation involves attending a total of 5 sessions. The study begins with a familiarization session, which includes measurements of weight, height, and the determination of the 20-repetition maximum load (i.e., the maximum load that can be lifted between 18-22 times), which will be used in the rest of the experimental sessions. In the experimental sessions, a supplement capsule will be administered 30 minutes before starting the resistance training. The composition of the capsule will not be disclosed to ensure a triple-blind approach for participants and evaluators. The resistance training will consist of 4 supersets (each superset consisting of two exercises: bench press and bench pull). There will be 5-minute breaks between each superset and 1.5-minute breaks between the two exercises within the same superset. During the supersets, the maximum number of repetitions will be performed until reaching muscle failure. Heart rate and blood pressure will be measured during the training, and perceived effort will be recorded. No physiological samples will be collected. This study aims to provide a clearer understanding of which supplement may have the most beneficial effects when training with light loads and repetitions to failure in a superset, a topic that has not been explored before. REQUEST DETAILS The professional attending to this study is Amador García Ramos. By signing this document, authorization is given to complete questionnaires about perceived effort. POTENTIAL BENEFITS AND RISKS No specific benefits or risks are expected. Participation will contribute to increasing scientific knowledge. No compensation will be provided for authorizing the use of health data. Additionally, the researchers involved in this project will not receive specific compensation for their participation in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 20, 2025

Last Update Submit

February 26, 2025

Conditions

Keywords

AdaptogensFatigueSports supplementationStrength trainingRhodiola RoseaVisuo-cognitive ProcessingTriple-Blinded Randomized Placebo Crossover Study

Outcome Measures

Primary Outcomes (1)

  • Strength training

    The general warm-up mirrored that of the 1RM assessment. Thereafter, the specific warm-up included for each exercise 2 sets of 3 repetitions at 30% and 50% of 1RM, and a final set of 2 repetitions at 70% of 1RM. The training regimen consisted of 8 alternating sets (4 sets each) of bench press and bench pull, with a 2-minute rest period between sets, performed at 70% of the 1RM load established during the preliminary testing session. Sets were terminated when 2 consecutive repetitions were performed at a MV below 0.35 m·s-1 for the bench press and 0.60 m·s-1 for the bench pull. Participants were encouraged to perform all repetitions at maximal intent, and they received real-time MV feedback (GymAware RS; Kinetic Performance Technologies, Canberra, Australia). Strength performance was assessed by recording the number of repetitions completed (Nrep) and the velocity of the fastest repetition (MVfastest) in each set. The OMNI-Resistance Exercise Scale (OMNI-RES) of perceived exertion was

    During training

Secondary Outcomes (2)

  • MOT test

    Baseline (before training) and immediately after training

  • Cognitively demanding and control tasks

    Baseline (before training)

Study Arms (4)

Rhodiola Rosea and mental fatigue

EXPERIMENTAL
Dietary Supplement: Rhodiola Rosea Capsules

Rhodiola Rosea and no fatigue

EXPERIMENTAL
Dietary Supplement: Rhodiola Rosea Capsules

Placebo and mental fatigue

EXPERIMENTAL
Dietary Supplement: Rhodiola Rosea Capsules

Placebo and no fatigue

EXPERIMENTAL
Dietary Supplement: Rhodiola Rosea Capsules

Interventions

Rhodiola Rosea CapsulesDIETARY_SUPPLEMENT

One of the most practical and accessible options for mitigating the occurrence of mental fatigue is the strategic use of nutritional supplements. Several nutritional supplements have been shown to reduce behavioural or subjective markers of mental fatigue, including caffeine, creatine, panax ginseng, and various vitamins or minerals. Among these, Rhodiola Rosea (RR), a supplement with purported adaptogenic and ergogenic properties, has gained attention. Several randomized controlled trials have reported reductions in mental fatigue after RR supplementation without adverse effects. The main objective of this study was to explore the effects of four days of Golden Root Extract (RR) supplementation on mental fatigue, visuo-cognitive processing, strength performance, and perceived exertion in young, healthy individuals.

Placebo and mental fatiguePlacebo and no fatigueRhodiola Rosea and mental fatigueRhodiola Rosea and no fatigue

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 40 years
  • At least one year of resistance training experience
  • Ability to execute the bench press and bench pull exercises at maximal intentional velocity with proper technique

You may not qualify if:

  • \- Any medical condition that could impede proper engagement in resistance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport Science

Granada, 18011, Spain

Location

Related Publications (2)

  • Shevtsov VA, Zholus BI, Shervarly VI, Vol'skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G. A randomized trial of two different doses of a SHR-5 Rhodiola rosea extract versus placebo and control of capacity for mental work. Phytomedicine. 2003 Mar;10(2-3):95-105. doi: 10.1078/094471103321659780.

    PMID: 12725561BACKGROUND
  • Spasov AA, Wikman GK, Mandrikov VB, Mironova IA, Neumoin VV. A double-blind, placebo-controlled pilot study of the stimulating and adaptogenic effect of Rhodiola rosea SHR-5 extract on the fatigue of students caused by stress during an examination period with a repeated low-dose regimen. Phytomedicine. 2000 Apr;7(2):85-9. doi: 10.1016/S0944-7113(00)80078-1.

    PMID: 10839209BACKGROUND

Related Links

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Group

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 3, 2025

Study Start

May 25, 2024

Primary Completion

August 30, 2024

Study Completion

September 15, 2024

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations