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Completed

NCT Number: NCT03961022

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

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.

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Key information

Conditions

Muscle Soreness Delayed-onset Muscle Soreness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

European University of Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyherbal supplement: ReWin(d) vs Placebo

Dietary Supplement

Supplementation during 4 weeks + 72 hours post acute exercice

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Natural Origins

Industry

Collaborators

  • European University of Madrid

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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