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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Granada, Spain, 18007
        • Recruiting
        • Instituto Mixto Universitario Deporte y Salud (IMUDS)
        • Contact:
        • 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:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Microcrystalline cellulose
Dietary supplement: Hibiscus sabdariffa extract
Daily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days.
Experimental: Hibiscus sabdariffa extract
520 mg of Hibiscus sabdariffa extract
Dietary supplement: Hibiscus sabdariffa extract
Daily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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