- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06125002
Diosmin for Treatment of Delayed-onset Muscle Soreness (DOMS) (UEL)
Evaluation of the Prophylactic Effects of the Flavonoid Diosmin on Delayed-onset Muscle Soreness in Humans: a Randomized, Double-blinded and Placebo-controlled Single-center Clinical Trial
Study Overview
Detailed Description
Main objective:
• Analyze the potential effects of supplementation with the flavonoid diosmin on DOMS in humans (athletes from the women's five-a-side soccer team from the city of Londrina, Paraná State, Brazil), using the proposed intense dynamic exercise protocol.
Specific objectives:
- Evaluate whether treatment with the flavonoid diosmin reduces muscle pain induced by the intense dynamic exercise protocol;
- Evaluate whether treatment with the flavonoid diosmin reduces systemic (serum) levels of total creatine phosphokinase (CFQ) and oxidative stress (lipid peroxidation and antioxidant capacity) induced by the intense dynamic exercise protocol;
- Evaluate whether treatment with the flavonoid diosmin is capable of improving the reduction in muscular performance and impairment of balance induced by the intense dynamic exercise protocol.
The present project will be carried out through a randomized, double-blinded and placebo-controlled clinical study. A total of approximately 40 female athletes pertaining to the Londrina Esporte Clube (name in Portuguese of the team) women's five-a-side soccer will be recruited for the study. The choice of exclusively women individuals is due to sexual dimorphism in pain perception, thus contributing to the results being more homogeneous and reliable. The criteria for inclusion of volunteer participants in the project will be to be between 16 and 35 years old, and to be able to perform the proposed intense dynamic exercise protocol. Exclusion criteria will include locomotor system dysfunctions or use of analgesic/anti-inflammatory medication at the time of recruitment, as well as being on a calorie-restricted diet or ergogenic supplementation. The study will consist of two experimental groups, made up of healthy individuals, who will perform the proposed intense dynamic exercise protocol, as follows: 1) control group that will receive placebo supplementation (corn starch tablets at a concentration of 750 mg); and 2) intervention group that will receive supplementation with diosmin (tablets at a concentration of 750 mg). Treatment of study participants will occur orally, and everyone will ingest identical opaque capsules containing placebo or diosmin with water. The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol. Each experimental group will consist of approximately 20 participants. The project is approved by the Research Ethics Committee (CEP) for Human Beings/Brazil Platform(protocol number 64025122.2.0000.0108). The selected participants will be informed about the objectives and methodology of the study and when there is agreement with the proposed design, the agreement to voluntarily participate in the study will be registered by means of an Informed Consent Form. The intense dynamic exercise modality proposed (concentric and eccentric contractions) for the study will follow the following approach: participants will perform a standardized muscle injury protocol that will consist of a sequence of three sets of repetitions until fatigue of bilateral muscle contractions on a leg-press machine with a 45° angle. Each The participant will have their load previously defined through the 1 repetition maximum (1RM) test, and 70% of the defined weight will be used during the intense dynamic exercise protocol. During each action, the load will be resisted with the legs placed on the leg-press supporter from full knee extension to the 90° knee flexion angle, lasting approximately 3-5 seconds. Between each series, participants will be able to take a 1-minute rest period. The intense dynamic exercise protocol that will be carried out by all participants will be supervised by the project manager and/or collaborators duly trained for such assessments. Participants' clinical signs will be monitored frequently during the activities and in case of discomfort, the activity will be stopped immediately. Analyzes of clinical and blood parameters will be carried out before the start (baseline) and after the end of the proposed intense dynamic exercise protocol (24 and 48 hours) aiming to investigate the possible effects of diosmin on DOMS and related pathological events.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Sergio M Borghi, Ph.D.
- Phone Number: +55 43 999189216
- Email: sborghi@uel.br
Study Contact Backup
- Name: Fabiana C Barreiros, Graduate
- Phone Number: +55 43 988322883
- Email: fabiana.barreiros@uel.br
Study Locations
-
-
Paraná
-
Londrina, Paraná, Brazil, 86057-970
- Recruiting
- Universidade Estadual de Londrina
-
Contact:
- Sergio M Borghi, Ph.D.
- Phone Number: +55 43 999189216
- Email: sborghi@uel.br
-
Contact:
- Fabiana C Barreiros, Graduate
- Phone Number: Borghi +55 43 988322883
- Email: sergio_borghi@yahoo.com.br
-
Principal Investigator:
- Sergio M Borghi
-
Sub-Investigator:
- Fabiana C Barreiros
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be within the pre-determined age range.
- Be able to perform the proposed intense dynamic exercise protocol.
Exclusion Criteria:
- Locomotor system dysfunctions.
- Use of analgesic/anti-inflammatory medication at the time of recruitment.
- Calorie-restricted diet or ergogenic supplementation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention (placebo, corn starch tablets)
Treatment will occur by oral route, and everyone will ingest identical opaque capsules (750 mg).
The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol.
|
The ingestion will occur orally, under monitoring by the responsible investigator.
Other Names:
|
Experimental: Intervention (diosmin)
Treatment will occur by oral route, and everyone will ingest identical opaque capsules (750 mg).
The treatment protocol will be applied before the start (pre-treatment) of the intense dynamic exercise sessions, once a day, during the two days before, and on the day (immediately before) the execution of the exercise protocol.
|
The ingestion will occur orally, under monitoring by the responsible investigator.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle soreness
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol
|
Evaluated by both digital algometer (in kilograms force; Kgf) and visual analogue (VAS) scale (in centimeters; cm), where 0 represents no pain and 10 the worst possible pain.
|
Basal, 24, and 48 hours after DOMS induction protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle tissue damage through the evaluation of the creatine phosphokinase (CPK) levels.
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol
|
Evaluated by spectrophotometric analysis using commercial kits (in milligram per liter; mg/L)
|
Basal, 24, and 48 hours after DOMS induction protocol
|
Plasmatic lipid peroxidation levels
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol
|
Evaluated by spectrophotometric analysis (in micromol per liter; µmol/L).
|
Basal, 24, and 48 hours after DOMS induction protocol
|
Plasmatic total antioxidant status
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol
|
Evaluated by spectrophotometric analysis (in millimol per liter; mmol/L).
|
Basal, 24, and 48 hours after DOMS induction protocol
|
Recovery of muscle function through the evaluation of the average and maximum torque of the knee extension for determining quadriceps strength (maximum voluntary isometric contraction; MVIC).
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol
|
Evaluated by isometric dynamometer (flexor/extension chair, in newton per meter; N/m).
|
Basal, 24, and 48 hours after DOMS induction protocol
|
Recovery of muscle function through vertical jump height.
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol.
|
Evaluated by jump strength (in milliseconds; msec).
|
Basal, 24, and 48 hours after DOMS induction protocol.
|
Bipedal and single-legged (unipedal) postural balance.
Time Frame: Basal, 24, and 48 hours after DOMS induction protocol.
|
Evaluated through the antero-posterior (AP) and mediolateral (ML) displacement velocities (in centimeter per seconds; cm/sec).
|
Basal, 24, and 48 hours after DOMS induction protocol.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sergio M Borghi, Universidade Estadual de Londrina
Publications and helpful links
General Publications
- Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
- Luque MZ, Aguiar AF, da Silva-Araujo AK, Zaninelli TH, Heintz OK, Saraiva-Santos T, Bertozzi MM, Souza NA, Junior EO, Verri WA Jr, Borghi SM. Evaluation of a preemptive intervention regimen with hesperidin methyl chalcone in delayed-onset muscle soreness in young adults: a randomized, double-blinded, and placebo-controlled trial study. Eur J Appl Physiol. 2023 Sep;123(9):1949-1964. doi: 10.1007/s00421-023-05207-2. Epub 2023 Apr 29.
- Borghi SM, Zaninelli TH, Saraiva-Santos T, Bertozzi MM, Cardoso RDR, Carvalho TT, Ferraz CR, Camilios-Neto D, Cunha FQ, Cunha TM, Pinho-Ribeiro FA, Casagrande R, Verri WA Jr. Brief research report: Repurposing pentoxifylline to treat intense acute swimming-Induced delayed-onset muscle soreness in mice: Targeting peripheral and spinal cord nociceptive mechanisms. Front Pharmacol. 2023 Jan 10;13:950314. doi: 10.3389/fphar.2022.950314. eCollection 2022.
- Bussulo SKD, Ferraz CR, Carvalho TT, Verri WA Jr, Borghi SM. Redox interactions of immune cells and muscle in the regulation of exercise-induced pain and analgesia: implications on the modulation of muscle nociceptor sensory neurons. Free Radic Res. 2021 Jul;55(7):757-775. doi: 10.1080/10715762.2021.1953696. Epub 2021 Jul 19.
- Heiss R, Lutter C, Freiwald J, Hoppe MW, Grim C, Poettgen K, Forst R, Bloch W, Huttel M, Hotfiel T. Advances in Delayed-Onset Muscle Soreness (DOMS) - Part II: Treatment and Prevention. Sportverletz Sportschaden. 2019 Mar;33(1):21-29. doi: 10.1055/a-0810-3516. Epub 2019 Mar 13.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64025122.2.0000.0108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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