NCT05653076

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

November 28, 2022

Last Update Submit

January 24, 2023

Conditions

Keywords

nutritional ergogenicssport supplementationanthocyaninspolyphenolsantioxidantsstrength

Outcome Measures

Primary Outcomes (3)

  • Explosive strength

    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

    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

    It will be measured by means of a CMJ with a load

    1 day (24h) after a bout of an intense resistance exercise

Secondary Outcomes (3)

  • Explosive strength

    3 days (72h) after a bout of an intense resistance exercise

  • Maximal dynamic force

    3 days (72h) after a bout of an intense resistance exercise

  • Ability to change direction

    3 days (72h) after a bout of an intense resistance exercise

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose

Dietary Supplement: Hibiscus sabdariffa extract

Hibiscus sabdariffa extract

EXPERIMENTAL

520 mg of Hibiscus sabdariffa extract

Dietary Supplement: Hibiscus sabdariffa extract

Interventions

Hibiscus sabdariffa extractDIETARY_SUPPLEMENT

Daily supplementation with 520 mg of Hibiscus sabdariffa extract for 10 days.

Hibiscus sabdariffa extractPlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Mixto Universitario Deporte y Salud (iMUDS)

Granada, 18007, Spain

RECRUITING

Facultad de Ciencias del Deporte

Granada, 18071, Spain

RECRUITING

Central Study Contacts

Francisco J Osuna-Prieto, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple-blinded
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 16, 2022

Study Start

January 23, 2023

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations