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

Phase 2

Completed

• Conditions: Muscle Soreness; Delayed-onset Muscle Soreness

• Registration Number: NCT03961022
• Lead Sponsor: Natural Origins

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

Study Timeline

• Study Start: 2018-10-22
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-05
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effects of ReWin(d) on muscle recovery induced by physical exercise	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 Outcome Measures

Name	Time	Method
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	Visual Analogue Scale pain perception after exercise-induced muscle damage
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	Heart Rate Variability assessment after exercise-induced muscle damage
Effects of ReWin(d) on Gut Microbiota	Change from baseline dose after 4 weeks of intervention	Determination of Microbiota composition by 16S rRNA Sequencing.
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	Muscle skin temperature monitored by IR-camera.

Trial Locations

Locations (1)

European University of Madrid; 🇪🇸 Villaviciosa De Odón, Madrid, Spain