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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Muscle Soreness, Delayed-onset Muscle Soreness

Intervention / Treatment
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* Dietary Supplement: Polyherbal supplement: ReWin(d) vs Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single dose, Randomized, Double Blinded, Placebo-controlled Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReWin(d)<br>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<br>* Supplementation during 4 weeks + 72 hours post acute exercice<br>|
| Placebo Comparator: placebo<br>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<br>* Supplementation during 4 weeks + 72 hours post acute exercice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of ReWin(d) on muscle damage induced by physical exercise | 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 | 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 | 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 | Determination of Microbiota composition by 16S rRNA Sequencing. | Change from baseline dose after 4 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DOMS, Fatigue rate, Heart rate variability, Pain, Jump performance