Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice
May 22, 2019 updated by: Margarita Pérez Ruiz, Natural Origins
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Villaviciosa De Odón, Madrid, Spain, 28670
- European University of Madrid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: ReWin(d)
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
|
Supplementation during 4 weeks + 72 hours post acute exercice
|
|
PLACEBO_COMPARATOR: placebo
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
|
Supplementation during 4 weeks + 72 hours post acute exercice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
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.
|
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
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
|
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
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
|
Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
|
|
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.
|
Change from baseline dose after 4 weeks of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Margarita Perez Ruiz, MD(Res), European University of Madrid
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 22, 2018
Primary Completion (ACTUAL)
December 21, 2018
Study Completion (ACTUAL)
December 21, 2018
Study Registration Dates
First Submitted
May 20, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (ACTUAL)
May 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nat.Origins-ReWin(d)-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.