Muscle SorenessPhase 2NCT03961022
Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice
A Phase 2 study of Muscle Soreness and Delayed-onset Muscle Soreness, run by Natural Origins at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness, Delayed-onset Muscle Soreness
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2018to 21 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Muscle Soreness, Delayed-onset Muscle Soreness
- Being tested
- Polyherbal supplement: ReWin(d) vs Placebo
- Keywords
- DOMS, Fatigue rate, Heart rate variability, Pain, Jump performance
- Medical subject headings
- Myalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyherbal supplement: ReWin(d) vs PlaceboDietary supplement
Supplementation during 4 weeks + 72 hours post acute exercice
| Study group | Role | What they receive |
|---|---|---|
| ReWin(d) | Active comparator | 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 Receives: Dietary Supplement: Polyherbal supplement: ReWin(d) vs Placebo |
| placebo | Placebo comparator | 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 Receives: Dietary Supplement: Polyherbal supplement: ReWin(d) vs Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of ReWin(d) on muscle recovery induced by physical exercise
Sport performance (effectiveness of a jump) after exercise-induced muscle damage
Measured: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
Secondary outcomes (4)
Effects of ReWin(d) on muscle damage induced by physical exercise
Muscle skin temperature monitored by IR-camera.
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline dose after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start22 Oct 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single dose, Randomized, Double Blinded, Placebo-controlled Study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Origins
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European University of Madrid
- Responsible party
- Principal investigator, Margarita Pérez Ruiz, European University of Madrid
- Investigators
- Margarita Perez Ruiz, MD(Res), Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961022
- Sponsor's protocol ID
- Nat.Origins-ReWin(d)-2019
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dominguez-Balmaseda D, Diez-Vega I, Larrosa M, San Juan AF, Issaly N, Moreno-Perez D, Burgos S, Sillero-Quintana M, Gonzalez C, Bas A, Roller M, Perez-Ruiz M. Effect of a Blend of Zingiber officinale Roscoe and Bixa orellana L. Herbal Supplement on the Recovery of Delayed-Onset Muscle Soreness Induced by Unaccustomed Eccentric Resistance Training: A Randomized, Triple-Blind, Placebo-Controlled Trial. Front Physiol. 2020 Jul 21;11:826. doi: 10.3389/fphys.2020.00826. eCollection 2020.
PubMed 32848820
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03961022
- Acronym / sponsor ID
- Nat.Origins-ReWin(d)-2019
- Conditions
- Muscle Soreness, Delayed-onset Muscle Soreness
- Keywords
- DOMS, Fatigue rate, Heart rate variability, Pain, Jump performance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Natural OriginsIndustry (pharma, biotech, devices)
- Collaborators
- European University of Madrid
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single dose, Randomized, Double Blinded, Placebo-controlled Study
| Arm | Type | Receives |
|---|---|---|
| ReWin(d) | Active comparator | Dietary Supplement: Polyherbal supplement: ReWin(d) vs PlaceboSubjects 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 |
| placebo | Placebo comparator | Dietary Supplement: Polyherbal supplement: ReWin(d) vs PlaceboSubjects 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 |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyherbal supplement: ReWin(d) vs PlaceboSupplementation during 4 weeks + 72 hours post acute exercice | Dietary supplement | ReWin(d), placebo |
Primary outcome
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
4 secondary outcomes
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
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
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
Effects of ReWin(d) on Gut Microbiota
Time frame: Change from baseline dose after 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Derived from this study: PubMed 32848820Dominguez-Balmaseda D, Diez-Vega I, Larrosa M, San Juan AF, Issaly N, Moreno-Perez D, Burgos S, Sillero-Quintana M, Gonzalez C, Bas A, Roller M, Perez-Ruiz M. Effect of a Blend of Zingiber officinale Roscoe and Bixa orellana L. Herbal Supplement on the Recovery of Delayed-Onset Muscle Soreness Induced by Unaccustomed Eccentric Resistance Training: A Randomized, Triple-Blind, Placebo-Controlled Trial. Front Physiol. 2020 Jul 21;11:826. doi: 10.3389/fphys.2020.00826. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Perez Ruiz, MD(Res) principal investigator
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Muscle Soreness and Delayed-onset Muscle Soreness, run by Natural Origins at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03961022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.