Diosmin for Treatment of Delayed-onset Muscle Soreness (DOMS)

NCT06125002 | Unknown Phase 1 DMC

• 1 other identifier: 64025122.2.0000.0108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The potential benefits of exercise for the treatment of chronic inflammatory diseases and pain have been well documented in the scientific literature. Psychiatric, neurological, metabolic and cardiovascular diseases are examples of conditions that impact the health and quality of life of the population. Due to the effects provided by exercise, it can modify the natural course of these diseases. This concept is important to justify the efforts made by government bodies committed to promoting exercise, such as the WHO. However, the habitual practice of physical activity following the primary guidelines may be hampered by some factors, including those that support the physiological repercussions of exercise on the body, such as muscle pain. In this sense, an important complicating factor such as delayed-onset muscle soreness (DOMS), present in the post-exercise recovery period, can impair adherence and permanence in physical activity programs, thus representing a considerable barrier to exercise promotion. They can also severely impair the performance of high-level athletes. Flavonoids, present in plants, but also in foods of the human diet, are known to have several biological properties, including analgesic, anti-inflammatory, and antioxidant effects. Currently, there are still few studies that have evaluated the effects of flavonoids on the development and evolution of DOMS in humans.

Conditions

Myalgia

Keywords

delayed-onset muscle soreness; DOMS; exercise; flavonoids; diosmin

Outcome Measures

Primary Outcomes (1)

• Muscle soreness

  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 Outcomes (6)

• Muscle tissue damage through the evaluation of the creatine phosphokinase (CPK) levels.

  Basal, 24, and 48 hours after DOMS induction protocol

• Plasmatic lipid peroxidation levels

  Basal, 24, and 48 hours after DOMS induction protocol

• Plasmatic total antioxidant status

  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).

  Basal, 24, and 48 hours after DOMS induction protocol

• Recovery of muscle function through vertical jump height.

  Basal, 24, and 48 hours after DOMS induction protocol.

Study Arms (2)

Intervention (placebo, corn starch tablets)

EXPERIMENTAL

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.

Drug: Placebo

Intervention (diosmin)

EXPERIMENTAL

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.

Drug: Diosmin750

Interventions

Diosmin750 DRUG

The ingestion will occur orally, under monitoring by the responsible investigator.

Also known as: Diosmine

Intervention (diosmin)

Placebo DRUG

The ingestion will occur orally, under monitoring by the responsible investigator.

Also known as: Corn starch tablets

Intervention (placebo, corn starch tablets)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be within the pre-determined age range.
• Be able to perform the proposed intense dynamic exercise protocol.

You may not qualify if:

• Locomotor system dysfunctions.
• Use of analgesic/anti-inflammatory medication at the time of recruitment.
• Calorie-restricted diet or ergogenic supplementation.

Sponsors & Collaborators

• Sergio Marques Borghi: lead
• Universidade Norte do Paraná: collaborator

Study Sites (1)

Universidade Estadual de Londrina

Londrina, Paraná, 86057-970, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 37119360 BACKGROUND

• 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.

  PMID: 36703752 BACKGROUND

• 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.

  PMID: 34238089 BACKGROUND

• 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.

  PMID: 12617692 BACKGROUND

• 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.

  PMID: 30865998 BACKGROUND

• da Cunha FCB, Cortez GB, Pucci IM, Silva MM, Borim JM, Bertozzi MM, Jacinto JL, Carvalho TT, Aguiar AF, Casonatto J, Junior EO, Verri WA Jr, Borghi SM. Effects of the Flavonoid Diosmin on Post Exercise Muscle Soreness - A Randomized Controlled Trial. J Diet Suppl. 2025;22(6):977-998. doi: 10.1080/19390211.2025.2547167. Epub 2025 Aug 16.

  PMID: 40818103 DERIVED

MeSH Terms

Conditions

Myalgia; Motor Activity

Interventions

Diosmin; Starch

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Sergio M Borghi

  Universidade Estadual de Londrina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio M Borghi, Ph.D.

CONTACT

+55 43 999189216; sborghi@uel.br

Fabiana C Barreiros, Graduate

CONTACT

+55 43 988322883; fabiana.barreiros@uel.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)