Neuromuscular PerformanceRECUPERA-TNCT05653076
Hibiscus Sabdariffa Extract Effect on Neuromuscular Performance
A study testing Hibiscus sabdariffa extract in people with Neuromuscular Performance, run by Universidad de Granada at 2 sites in Spain.
Trial summary
Exercise-induced muscle damage (EIMD) is a transient problem that athletes face after performing more intense and/or prolonged exercise than they are used to. EIMD is accompanied by an increase in the production of reactive oxygen species and a decrease in the antioxidant capacity of the organism. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Performance
- What is being tested?
- Hibiscus sabdariffa extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesSpain
- Study dates
- 23 Jan 2023to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-35 years.
- Body mass index: 18.5-30 kg/m2
- Be able to understand the instructions, objectives, and protocol of the study.
- Trained in some force sports discipline ≥1 year prior to the study and accustomed to carrying out the exercises of the evaluation protocol.
Who cannot join
- History of a major adverse cardiovascular event, renal failure, cirrhosis, eating disorder, polycystic ovarian syndrome, weight control surgery, type 2 diabetes mellitus, or HIV/AIDS.
- Any chronic pathology in which the intake of nutritional supplements is not recommended.
- Any condition that, in the investigator's judgment, impairs the ability to participate in the study or represents a personal risk to the participant.
- Use of medications that may affect the results of the study.
- Unstable body weight for 3 months prior to study start (>4 kg weight gain or loss)
- Routine use of teas/infusions/supplements rich in polyphenols.
Show all 9Show fewer
- Pregnancy and lactation.
- Active tobacco or illicit drug use or history of treatment for alcohol abuse.
- To be on a special diet or prescribed for other reasons (eg celiac disease).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Instituto Mixto Universitario Deporte y Salud (iMUDS)
Granada, 18007
Francisco Javier O Osuna-Prieto, PhD., +34 618117577, fjosunaprieto@ugr.es
Francisco J. Osuna-Prieto, PhD.
- Recruiting
Facultad de Ciencias del Deporte
Granada, 18071
Francisco J O Osuna-Prieto, PhD, +34 618117577, fjosunaprieto@ugr.es
About this study
Official title: Hibiscus Sabdariffa Extract Effect on Neuromuscular Performance After Intense Resistance Exercise: a Randomized, Placebo-controlled, Crossover Study
Exercise-induced muscle damage (EIMD) is a transient problem that athletes face after performing more intense and/or prolonged exercise than they are used to. EIMD is accompanied by an increase in the production of reactive oxygen species and a decrease in the antioxidant capacity of the organism. This phenomenon decreases the performance capacity of athletes due to impaired muscle strength and range of motion. Among the strategies to reduce EIMD, the use of nutritional strategies rich in antioxidants such as polyphenols stands out. In this sense, the extract of Hibiscus sabdariffa is particularly rich in polyphenolic antioxidants, among which anthocyanins stand out. Previous studies have concluded that the administration of an extract of Hibiscus sabdariffa can prevent overtraining syndrome by reducing the levels of oxidizing agents and increasing the body's antioxidant defenses. However, despite the fact that Hibiscus sabdariffa extract has been shown to be safe for humans to ingest and have various health benefits, to our knowledge, no studies have evaluated its ability to minimize neuromuscular performance impairment that occurs after performing an intense session of strength training. Based on previous evidence, we hypothesize that supplementation with an extract of Hibiscus sabdariffa will improve neuromuscular performance after performing intense resistance exercise in young (18-35 years) and trained adults, with at least 1 year of experience training. strength. The design of this study is crossover, randomized and placebo controlled, where each individual will act as her own control. The neuromuscular performance parameters to be evaluated will be: i) explosive strength - main variable, in terms of countermovement jump height (CMJ); ii) the maximum dynamic force; and iii) the ability to change direction, all of them 24h and 72h after a high-intensity strength training session. If our hypothesis is confirmed, the results of our study would not only have an impact at a scientific level but also at a commercial level through the development of supplements and/or functional foods.
- Conditions
- Neuromuscular Performance
- Being tested
- Hibiscus sabdariffa extract
- Keywords
- nutritional ergogenics, sport supplementation, anthocyanins, polyphenols, antioxidants, strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hibiscus sabdariffa extractDietary supplement
Daily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Microcrystalline cellulose Receives: Dietary Supplement: Hibiscus sabdariffa extract |
| Hibiscus sabdariffa extract | Experimental | 520 mg of Hibiscus sabdariffa extract Receives: Dietary Supplement: Hibiscus sabdariffa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explosive strength
It will be measured through the height of the countermovement jump (CMJ)
Measured: 1 day (24h) after a bout of an intense resistance exercise
Maximal dynamic force
It will be measured by means of a CMJ with a load
Measured: 1 day (24h) after a bout of an intense resistance exercise
Ability to change direction
It will be measured by means of a CMJ with a load
Measured: 1 day (24h) after a bout of an intense resistance exercise
Secondary outcomes (3)
Explosive strength
It will be measured through the height of the countermovement jump (CMJ)
Measured: 3 days (72h) after a bout of an intense resistance exercise
Maximal dynamic force
It will be measured by means of a CMJ with a load
Measured: 3 days (72h) after a bout of an intense resistance exercise
Ability to change direction
It will be measured by repeated sprint T-test
Measured: 3 days (72h) after a bout of an intense resistance exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start23 Jan 2023
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Osuna-Prieto, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653076
- Sponsor's protocol ID
- 1364-N-22
- Acronym
- RECUPERA-T
- Status last verified
- Jan 2023
- First submitted
- 28 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hibiscus Sabdariffa Extract Effect on Neuromuscular Performance After Intense Resistance Exercise: a Randomized, Placebo-controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT05653076
- Acronym / sponsor ID
- RECUPERA-T / 1364-N-22
- Conditions
- Neuromuscular Performance
- Keywords
- nutritional ergogenics, sport supplementation, anthocyanins, polyphenols, antioxidants, strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise-induced muscle damage (EIMD) is a transient problem that athletes face after performing more intense and/or prolonged exercise than they are used to. EIMD is accompanied by an increase in the production of reactive oxygen species and a decrease in the antioxidant capacity of the organism. This phenomenon decreases the performance capacity of athletes due to impaired muscle strength and range of motion. Among the strategies to reduce EIMD, the use of nutritional strategies rich in antioxidants such as polyphenols stands out. In this sense, the extract of Hibiscus sabdariffa is particularly rich in polyphenolic antioxidants, among which anthocyanins stand out. Previous studies have concluded that the administration of an extract of Hibiscus sabdariffa can prevent overtraining syndrome by reducing the levels of oxidizing agents and increasing the body's antioxidant defenses. However, despite the fact that Hibiscus sabdariffa extract has been shown to be safe for humans to ingest and have various health benefits, to our knowledge, no studies have evaluated its ability to minimize neuromuscular performance impairment that occurs after performing an intense session of strength training. Based on previous evidence, we hypothesize that supplementation with an extract of Hibiscus sabdariffa will improve neuromuscular performance after performing intense resistance exercise in young (18-35 years) and trained adults, with at least 1 year of experience training. strength. The design of this study is crossover, randomized and placebo controlled, where each individual will act as her own control. The neuromuscular performance parameters to be evaluated will be: i) explosive strength - main variable, in terms of countermovement jump height (CMJ); ii) the maximum dynamic force; and iii) the ability to change direction, all of them 24h and 72h after a high-intensity strength training session. If our hypothesis is confirmed, the results of our study would not only have an impact at a scientific level but also at a commercial level through the development of supplements and/or functional foods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Hibiscus sabdariffa extractMicrocrystalline cellulose |
| Hibiscus sabdariffa extract | Experimental | Dietary Supplement: Hibiscus sabdariffa extract520 mg of Hibiscus sabdariffa extract |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-35 years.
- Body mass index: 18.5-30 kg/m2
- Be able to understand the instructions, objectives, and protocol of the study.
- Trained in some force sports discipline ≥1 year prior to the study and accustomed to carrying out the exercises of the evaluation protocol.
Key exclusion criteria (9 listed)
- History of a major adverse cardiovascular event, renal failure, cirrhosis, eating disorder, polycystic ovarian syndrome, weight control surgery, type 2 diabetes mellitus, or HIV/AIDS.
- Any chronic pathology in which the intake of nutritional supplements is not recommended.
- Any condition that, in the investigator's judgment, impairs the ability to participate in the study or represents a personal risk to the participant.
- Use of medications that may affect the results of the study.
- Unstable body weight for 3 months prior to study start (>4 kg weight gain or loss)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hibiscus sabdariffa extractDaily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days. | Dietary supplement | Hibiscus sabdariffa extract, Placebo |
Primary outcome
Explosive strength
Time frame: 1 day (24h) after a bout of an intense resistance exercise
It will be measured through the height of the countermovement jump (CMJ)
Maximal dynamic force
Time frame: 1 day (24h) after a bout of an intense resistance exercise
It will be measured by means of a CMJ with a load
Ability to change direction
Time frame: 1 day (24h) after a bout of an intense resistance exercise
It will be measured by means of a CMJ with a load
3 secondary outcomes
Explosive strength
Time frame: 3 days (72h) after a bout of an intense resistance exercise
Maximal dynamic force
Time frame: 3 days (72h) after a bout of an intense resistance exercise
Ability to change direction
Time frame: 3 days (72h) after a bout of an intense resistance exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Performance
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Active, not recruiting
Effects of Blood Flow Restriction Training on Physical Function, Muscle Adaptations, and Performance in Roller Skaters
Athletic Performance Enhancement
Not yet recruiting
Effects of Hydrogen-rich Water Consumption on Transient Fatigue During an Official Football Match.
Exercise-Induced Fatigue, Football Performance
Recruiting
The Effect of Olive Leaf Extract Supplementation on Training-induced Skeletal Muscle Functional and Molecular Adaptations in Healthy Volunteers
Healthy Adult Participants, Exercise Training
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hibiscus sabdariffa extract in people with Neuromuscular Performance, run by Universidad de Granada at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco J Osuna-Prieto, PhD (+34 618117577, fjosunaprieto@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explosive strength (time frame: 1 day (24h) after a bout of an intense resistance exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.