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

May 22, 2019 updated by: Margarita Pérez Ruiz, Natural Origins

Effects of Dietary Supplementation With ReWin(d) on the Recovery of Young Athletes Suffering From Delayed-Onset Muscle Soreness Induced by Acute Exercice: A Pilot Randomized, Double-blind, Placebo Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Villaviciosa De Odón, Madrid, Spain, 28670
        • European University of Madrid

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

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Dietary supplement: Polyherbal supplement: ReWin(d) vs Placebo
Supplementation during 4 weeks + 72 hours post acute exercice
PLACEBO_COMPARATOR: 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
Dietary supplement: Polyherbal supplement: ReWin(d) vs Placebo
Supplementation during 4 weeks + 72 hours post acute exercice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of ReWin(d) on muscle recovery induced by physical exercise
Time Frame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
Sport performance (effectiveness of a jump) after exercise-induced muscle damage
Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of ReWin(d) on muscle damage induced by physical exercise
Time Frame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
Muscle skin temperature monitored by IR-camera.
Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
Effects of ReWin(d) on pain perception induced by physical exercise
Time Frame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
Visual Analogue Scale pain perception after exercise-induced muscle damage
Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
Effects of ReWin(d) on fatigue rate induced by physical exercise
Time Frame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
Heart Rate Variability assessment after exercise-induced muscle damage
Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
Effects of ReWin(d) on Gut Microbiota
Time Frame: Change from baseline dose after 4 weeks of intervention
Determination of Microbiota composition by 16S rRNA Sequencing.
Change from baseline dose after 4 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Origins

Collaborators

European University of Madrid

Investigators

  • Principal Investigator: Margarita Perez Ruiz, MD(Res), European University of Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 22, 2018

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (ACTUAL)

May 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nat.Origins-ReWin(d)-2019

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.

Clinical Trials on Muscle Soreness

Clinical Trials on Polyherbal supplement: ReWin(d) vs Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe