Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice

NCT ID: NCT03961022

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2018-12-21

Brief Summary

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The study will assess the recovery and performance of young athletes suffering from muscle damage induced by physical exercise. Model by comparing the safety and efficacy of ReWin(d) supplemention during 4 weeks to placebo over 72 hours post exercice.

Detailed Description

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Double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study.

40 healthy young male athetes were randomly assigned to the ReWin(d) or Placebo group. After 4 weeks supplementation (either 2 g daily of ReWin(d) capsules or placebo capsules). the participants were subjected to a 1 hour plyometric exercise session to induce DOMS. At 0 hours, 24 hours, 48 hours and 72 hours post exercise, the volunteers have been assessed to determine: (i) pain perception, (ii) fatigue rate, (iii) sport performance (effectiveness of a jump) and (iv) muscle damage and inflammation by I-R thermography and biomarkers

Conditions

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Muscle Soreness Delayed-onset Muscle Soreness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single dose, Randomized, Double Blinded, Placebo-controlled Study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ReWin(d)

Subjects have to take ReWin(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks + 3 days after acute exercice

Group Type ACTIVE_COMPARATOR

Polyherbal supplement: ReWin(d) vs Placebo

Intervention Type DIETARY_SUPPLEMENT

Supplementation during 4 weeks + 72 hours post acute exercice

placebo

Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks + 3 days after acute exercice

Group Type PLACEBO_COMPARATOR

Polyherbal supplement: ReWin(d) vs Placebo

Intervention Type DIETARY_SUPPLEMENT

Supplementation during 4 weeks + 72 hours post acute exercice

Interventions

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Polyherbal supplement: ReWin(d) vs Placebo

Supplementation during 4 weeks + 72 hours post acute exercice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* \> 18 years old
* Young athletes
* Training at least 3 times per week
* Agree not to initiate any new exercise or diet programs during the entire study period
* Agree not to change their current diet or exercise program during the entire study period
* Agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment for the duration of the trial.

Exclusion Criteria

* Previous history of upper extremity injury or knee joint pain
* Use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study
* Daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
* Antibiotic use in past 3 months
* Chronic disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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European University of Madrid

OTHER

Sponsor Role collaborator

Natural Origins

INDUSTRY

Sponsor Role lead

Responsible Party

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Margarita Pérez Ruiz

Principal Investigator. Full Profesor in Physical Activity and Sport. Exercise physiology.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margarita Perez Ruiz, MD(Res)

Role: PRINCIPAL_INVESTIGATOR

European University of Madrid

Locations

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European University of Madrid

Villaviciosa de Odón, Madrid, Spain

Site Status

Countries

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Spain

References

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Dominguez-Balmaseda D, Diez-Vega I, Larrosa M, San Juan AF, Issaly N, Moreno-Perez D, Burgos S, Sillero-Quintana M, Gonzalez C, Bas A, Roller M, Perez-Ruiz M. Effect of a Blend of Zingiber officinale Roscoe and Bixa orellana L. Herbal Supplement on the Recovery of Delayed-Onset Muscle Soreness Induced by Unaccustomed Eccentric Resistance Training: A Randomized, Triple-Blind, Placebo-Controlled Trial. Front Physiol. 2020 Jul 21;11:826. doi: 10.3389/fphys.2020.00826. eCollection 2020.

Reference Type DERIVED
PMID: 32848820 (View on PubMed)

Other Identifiers

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Nat.Origins-ReWin(d)-2019

Identifier Type: -

Identifier Source: org_study_id

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