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

Primary Purpose

Muscle Soreness, Delayed-onset Muscle Soreness

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Polyherbal supplement: ReWin(d) vs Placebo

About this trial

This is an interventional treatment trial for Muscle Soreness focused on measuring DOMS, Fatigue rate, Heart rate variability, Pain, Jump performance

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

European University of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ReWin(d)

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effects of ReWin(d) on muscle recovery induced by physical exercise

Sport performance (effectiveness of a jump) after exercise-induced muscle damage

Secondary Outcome Measures

Effects of ReWin(d) on muscle damage induced by physical exercise

Muscle skin temperature monitored by IR-camera.

Effects of ReWin(d) on pain perception induced by physical exercise

Visual Analogue Scale pain perception after exercise-induced muscle damage

Effects of ReWin(d) on fatigue rate induced by physical exercise

Heart Rate Variability assessment after exercise-induced muscle damage

Effects of ReWin(d) on Gut Microbiota

Determination of Microbiota composition by 16S rRNA Sequencing.

Full Information

NCT ID

NCT03961022

First Posted

May 20, 2019

Last Updated

May 22, 2019

Sponsor

Natural Origins

Collaborators

European University of Madrid

1. Study Identification

Unique Protocol Identification Number

NCT03961022

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

December 21, 2018 (Actual)

Study Completion Date

December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Natural Origins

Collaborators

European University of Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Soreness, Delayed-onset Muscle Soreness

Keywords

DOMS, Fatigue rate, Heart rate variability, Pain, Jump performance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ReWin(d)

Arm Type

Active Comparator

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Polyherbal supplement: ReWin(d) vs Placebo

Intervention Description

Supplementation during 4 weeks + 72 hours post acute exercice

Primary Outcome Measure Information:

Title

Effects of ReWin(d) on muscle recovery induced by physical exercise

Description

Sport performance (effectiveness of a jump) after exercise-induced muscle damage

Time Frame

Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS

Secondary Outcome Measure Information:

Title

Effects of ReWin(d) on muscle damage induced by physical exercise

Description

Muscle skin temperature monitored by IR-camera.

Time Frame

Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS

Title

Effects of ReWin(d) on pain perception induced by physical exercise

Description

Visual Analogue Scale pain perception after exercise-induced muscle damage

Time Frame

Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session

Title

Effects of ReWin(d) on fatigue rate induced by physical exercise

Description

Heart Rate Variability assessment after exercise-induced muscle damage

Time Frame

Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session

Title

Effects of ReWin(d) on Gut Microbiota

Description

Determination of Microbiota composition by 16S rRNA Sequencing.

Time Frame

Change from baseline dose after 4 weeks of intervention

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margarita Perez Ruiz, MD(Res)

Organizational Affiliation

European University of Madrid

Official's Role

Principal Investigator

Facility Information:

Facility Name

European University of Madrid

City

Villaviciosa De Odón

State/Province

Madrid

ZIP/Postal Code

28670

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32848820

Citation

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.

Results Reference

derived

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

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