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

Muscle Soreness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961022
• Other study ID #: Nat.Origins-ReWin(d)-2019
• Status: Completed
• Phase: Phase 2
• Start date: October 22, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: May 2019
• Source: Natural Origins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed-onset Muscle Soreness
• Muscle Soreness
• Myalgia

Intervention

Dietary Supplement:
• Polyherbal supplement: ReWin(d) vs Placebo
Supplementation during 4 weeks + 72 hours post acute exercice

Locations

Country	Name	City	State
Spain	European University of Madrid	Villaviciosa De Odón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Natural Origins	European University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Effects of ReWin(d) on Gut Microbiota	Determination of Microbiota composition by 16S rRNA Sequencing.	Change from baseline dose after 4 weeks of intervention