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

NCT03961022 | Completed Phase 2

• 1 other identifier: Nat.Origins-ReWin(d)-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Soreness; Delayed-onset Muscle Soreness

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

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

  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

  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

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

• Effects of ReWin(d) on Gut Microbiota

  Change from baseline dose after 4 weeks of intervention

Study Arms (2)

ReWin(d)

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

Polyherbal supplement: ReWin(d) vs Placebo DIETARY_SUPPLEMENT

Supplementation during 4 weeks + 72 hours post acute exercice

ReWin(d); placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Origins: lead
• European University of Madrid: collaborator

Study Sites (1)

European University of Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Related Publications (1)

• 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.

  PMID: 32848820 DERIVED

MeSH Terms

Conditions

Myalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margarita Perez Ruiz, MD(Res)

  European University of Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Full Profesor in Physical Activity and Sport. Exercise physiology.

Model Details: Single dose, Randomized, Double Blinded, Placebo-controlled Study

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 23, 2019
• Study Start: October 22, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

ES (1)