- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05653076
Hibiscus Sabdariffa Extract Effect on Neuromuscular Performance (RECUPERA-T)
January 24, 2023 updated by: Francisco Javier Osuna-Prieto, Universidad de Granada
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francisco J Osuna-Prieto, PhD
- Phone Number: +34 618117577
- Email: fjosunaprieto@ugr.es
Study Locations
-
-
-
Granada, Spain, 18007
- Recruiting
- Instituto Mixto Universitario Deporte y Salud (IMUDS)
-
Contact:
- Francisco Javier O Osuna-Prieto, PhD.
- Phone Number: +34 618117577
- Email: fjosunaprieto@ugr.es
-
Principal Investigator:
- Francisco J. Osuna-Prieto, PhD.
-
Principal Investigator:
- Jonatan. R. Ruiz, PhD.
-
Sub-Investigator:
- Juan José Martín-Olmedo
-
Sub-Investigator:
- Antonio Segura-Carretero, Professor
-
Granada, Spain, 18071
- Recruiting
- Facultad de Ciencias del Deporte
-
Contact:
- Francisco J O Osuna-Prieto, PhD
- Phone Number: +34 618117577
- Email: fjosunaprieto@ugr.es
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Microcrystalline cellulose
|
Daily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days.
|
|
Experimental: Hibiscus sabdariffa extract
520 mg of Hibiscus sabdariffa extract
|
Daily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
1 day (24h) after a bout of an intense resistance exercise
|
|
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
|
1 day (24h) after a bout of an intense resistance exercise
|
|
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
|
1 day (24h) after a bout of an intense resistance exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explosive strength
Time Frame: 3 days (72h) after a bout of an intense resistance exercise
|
It will be measured through the height of the countermovement jump (CMJ)
|
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
|
It will be measured by means of a CMJ with a load
|
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
|
It will be measured by repeated sprint T-test
|
3 days (72h) after a bout of an intense resistance exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2023
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
November 28, 2022
First Submitted That Met QC Criteria
December 7, 2022
First Posted (Actual)
December 16, 2022
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 24, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1364-N-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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