Clinical trial NCT03961022: Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Soreness
Delayed-onset Muscle Soreness
Keywords: DOMS
Fatigue rate
Heart rate variability
Pain
Jump performance
Lead sponsor: Natural Origins
Sponsor class: INDUSTRY
Collaborators: name: European University of Madrid
First posted: 2019-05-23
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single dose, Randomized, Double Blinded, Placebo-controlled Study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Effects of ReWin(d) on muscle recovery induced by physical exercise
timeFrame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
Secondary outcomes:
measure: Effects of ReWin(d) on muscle damage induced by physical exercise
timeFrame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
measure: Effects of ReWin(d) on pain perception induced by physical exercise
timeFrame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
measure: Effects of ReWin(d) on fatigue rate induced by physical exercise
timeFrame: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session
measure: Effects of ReWin(d) on Gut Microbiota
timeFrame: Change from baseline dose after 4 weeks of intervention
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: European University of Madrid
state: Madrid
Study officials:
affiliation: European University of Madrid
name: Margarita Perez Ruiz, MD(Res)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.