Delayed Onset Muscle SorenessNCT07877441
Antioxidant Supplementation and Muscle Recovery From DOMS in Trained Women
A study testing Creatine Monohydrate, Omega 3 FA (Fish Oil) and N-Acetyl Cysteine (NAC) in people with Delayed Onset Muscle Soreness and Exercise-induced Muscle Damage, run by Antonio Molina Lopez at 1 site in Spain.
Trial summary
This randomized, placebo-controlled, parallel-group trial investigated the effects of combined antioxidant and anti-inflammatory supplementation on delayed onset muscle soreness (DOMS) recovery in trained women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness, Exercise-induced Muscle Damage, Muscle Recovery
- What is being tested?
- Creatine Monohydrate, Omega 3 FA (Fish Oil) and N-Acetyl Cysteine (NAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2026to 23 Apr 2026
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female sex
- Age 18-35 years
- Trained status (regular resistance or sport training)
- Enrolled at Universidad Europea de Madrid
- Absence of musculoskeletal injury at time of recruitment
- No use of anti-inflammatory drugs or nutritional supplements in the 4 weeks prior to the study
Who cannot join
- History of chronic musculoskeletal or cardiovascular disease
- Use of anti-inflammatory medication or antioxidant supplementation in the prior 4 weeks
- Pregnancy or breastfeeding
- Inability to complete the eccentric exercise protocol
- Non-compliance with supplementation or dietary control requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-escalating Antioxidant Supplementation and Neuromuscular Recovery From Exercise-induced Muscle Damage in Trained Women: a Four-arm Randomized Controlled Trial
This randomized, placebo-controlled, parallel-group trial investigated the effects of combined antioxidant and anti-inflammatory supplementation on delayed onset muscle soreness (DOMS) recovery in trained women. Sixty trained women (18-35 years) were randomized into four groups: G1 (Creatine + Omega-3), G2 (Creatine + Omega-3 + NAC), G3 (Creatine + Omega-3 + NAC + CoQ10), and G4 (Placebo). Outcomes included muscle pain pressure threshold, countermovement jump, handgrip strength, 30-meter sprint, bilateral dynamometry, infrared thermography, creatine kinase, and heart rate variability, assessed before and after an eccentric exercise protocol.
Read the detailed description
Delayed onset muscle soreness (DOMS) is a common physiological response to eccentric exercise, characterized by muscle pain, reduced force production, and impaired neuromuscular function. Antioxidant and anti-inflammatory compounds such as creatine, omega-3 fatty acids, N-acetylcysteine (NAC), and coenzyme Q10 (CoQ10) have been proposed as potential modulators of exercise-induced muscle damage. This study used a 4-arm parallel RCT design with participant and assessor blinding. Participants underwent a standardized eccentric exercise protocol to induce DOMS, followed by 72 hours of monitoring. Measurements were taken at baseline (T1), post-exercise (T2), 24h (T3), 48h (T4), and 72h (T5) post-exercise. Analysis of covariance (ANCOVA) was performed with baseline values and age as covariates.
- Being tested
- Creatine Monohydrate, Omega 3 FA (Fish Oil), N-Acetyl Cysteine (NAC), Coenzyme Q10 100 MG Oral Capsule, Placebo
- Keywords
- DOMS, ANTIOXIDANT SUPPLEMENTATION, ECCENTRIC EXERCISE, TRAINED WOMEN, MUSCLE RECOVERY, RANDOMIZED CONTROLLED TRIAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Creatine monohydrate administered at 5 g/day for 4 weeks. Used in G1, G2, and G3 arms
Omega 3 FA (Fish Oil)Dietary supplement
Administered as 2 capsules/day (456 mg EPA + 225 mg DHA per capsule; EPA:DHA ratio 2:1) for 4 weeks. Included in G1, G2, and G3 arms.
N-Acetyl Cysteine (NAC)Dietary supplement
Administered at 600 mg/day for 4 weeks. Included in G2 and G3 arms.
Coenzyme Q10 100 MG Oral CapsuleDietary supplement
Administered at 100 mg/day for 4 weeks. Included in G3 arm only.
PlaceboDietary supplement
Maltodextrin (5 g/day) and olive oil capsules (2 capsules/day), visually identical to active arms. Administered for 4 weeks in G4 arm.
| Study group | Role | What they receive |
|---|---|---|
| G1: Creatine + Omega-3 | Experimental | Participants received creatine monohydrate (5 g/day) combined with omega-3 fish oil (2 capsules/day; 456 mg EPA + 225 mg DHA per capsule) for 4 weeks. The final week coincided with the 5 assessment timepoints following the eccentric exercise protocol to induce DOMS. Receives: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Omega 3 FA (Fish Oil) |
| G2: Creatina + Omega-3 + NAC | Experimental | Participants received creatine monohydrate (5 g/day), omega-3 fish oil (2 capsules/day; 456 mg EPA + 225 mg DHA), N-acetylcysteine (600 mg/day) for 4 weeks. The final week coincided with the 5 assessment timepoints following the eccentric exercise protocol to induce DOMS. Receives: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Omega 3 FA (Fish Oil); Dietary Supplement: N-Acetyl Cysteine (NAC) |
| G3: Creatina + Omega-3 + NAC + CoQ10 | Experimental | Participants received creatine monohydrate (5 g/day), omega-3 fish oil (2 capsules/day; 456 mg EPA + 225 mg DHA), N-acetylcysteine (600 mg/day), and coenzyme Q10 (100 mg/day) for 4 weeks. The final week coincided with the 5 assessment timepoints following the eccentric exercise protocol to induce DOMS. Receives: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Omega 3 FA (Fish Oil); Dietary Supplement: N-Acetyl Cysteine (NAC); Dietary Supplement: Coenzyme Q10 100 MG Oral Capsule |
| G4: Placebo | Experimental | Participants received a placebo consisting of maltodextrin (5 g/day) and olive oil capsules (2 capsules/day), visually identical to the active arms in capsule size, sachet format, and packaging colour, for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Countermovement Jump Height (CMJ)
Assessed using My Jump Lab app (240 fps). Jump height in centimeters as indicator of lower limb neuromuscular performance recovery
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Muscle Pain Pressure Threshold
Assessed using a pressure algometer (BASELINE). Measures the minimum pressure at which the participant perceives pain, expressed in kg/cm²
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
30- Meter Sprint Time
Assessed using Witty photocell system (Microgate). Time in seconds to complete a 30-meter sprint.
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Creatine Kinase (CK)
ssessed using SimplexTAS 101 analyzer. Serum CK activity in U/L as a biochemical marker of muscle damage.
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Secondary outcomes (4)
RIGHT LEG DYNAMOMENTRY
Assessed using Activforce 2 dynamometer. Maximum isometric knee extension force in kg.
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
LEFT LEG DYNAMOMETRY
Assessed using Activforce 2 dynamometer. Maximum isometric knee extension force in kg.
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Thermography
Assessed using FLIR T2 A315 thermographic camera. Skin temperature of the quadriceps region in degrees Celsius as marker of local inflammation.
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Heart Rate Variability
Assessed using Polar Team Pro chest straps. 5-minute supine recording with eyes closed and deep breathing. Root mean square of successive differences in ms as autonomic recovery indicator.
Measured: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start19 Feb 2026
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Molina Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- NUTRIFARMA, Unifarco SpA
- Responsible party
- Sponsor-investigator, Antonio Molina Lopez, Universidad Pablo de Olavide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877441
- Sponsor's protocol ID
- 23_CEIIR_2025
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the published article, after de-identification, will be made available upon reasonable request to the corresponding author. Data will include all outcome variables assessed at each time point (T1-T5) for all 60 participants. Requests should be directed to the corresponding author and will be considered on a case-by-case basis following publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-escalating Antioxidant Supplementation and Neuromuscular Recovery From Exercise-induced Muscle Damage in Trained Women: a Four-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07877441
- Acronym / sponsor ID
- 23_CEIIR_2025
- Keywords
- DOMS, ANTIOXIDANT SUPPLEMENTATION, ECCENTRIC EXERCISE, TRAINED WOMEN, MUSCLE RECOVERY, RANDOMIZED CONTROLLED TRIAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antonio Molina LopezUniversity, hospital or other
- Collaborators
- NUTRIFARMA, Unifarco SpA
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 16 Oct 2026 (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.
This randomized, placebo-controlled, parallel-group trial investigated the effects of combined antioxidant and anti-inflammatory supplementation on delayed onset muscle soreness (DOMS) recovery in trained women. Sixty trained women (18-35 years) were randomized into four groups: G1 (Creatine + Omega-3), G2 (Creatine + Omega-3 + NAC), G3 (Creatine + Omega-3 + NAC + CoQ10), and G4 (Placebo). Outcomes included muscle pain pressure threshold, countermovement jump, handgrip strength, 30-meter sprint, bilateral dynamometry, infrared thermography, creatine kinase, and heart rate variability, assessed before and after an eccentric exercise protocol.
Detailed description
Delayed onset muscle soreness (DOMS) is a common physiological response to eccentric exercise, characterized by muscle pain, reduced force production, and impaired neuromuscular function. Antioxidant and anti-inflammatory compounds such as creatine, omega-3 fatty acids, N-acetylcysteine (NAC), and coenzyme Q10 (CoQ10) have been proposed as potential modulators of exercise-induced muscle damage. This study used a 4-arm parallel RCT design with participant and assessor blinding. Participants underwent a standardized eccentric exercise protocol to induce DOMS, followed by 72 hours of monitoring. Measurements were taken at baseline (T1), post-exercise (T2), 24h (T3), 48h (T4), and 72h (T5) post-exercise. Analysis of covariance (ANCOVA) was performed with baseline values and age as covariates.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1: Creatine + Omega-3 | Experimental | Dietary Supplement: Creatine Monohydrate, Dietary Supplement: Omega 3 FA (Fish Oil)Participants received creatine monohydrate (5 g/day) combined with omega-3 fish oil (2 capsules/day; 456 mg EPA + 225 mg DHA per capsule) for 4 weeks. The final week coincided with the 5 assessment timepoints following the eccentric exercise protocol to induce DOMS. |
| G2: Creatina + Omega-3 + NAC | Experimental | Dietary Supplement: Creatine Monohydrate, Dietary Supplement: Omega 3 FA (Fish Oil), Dietary Supplement: N-Acetyl Cysteine (NAC)Participants received creatine monohydrate (5 g/day), omega-3 fish oil (2 capsules/day; 456 mg EPA + 225 mg DHA), N-acetylcysteine (600 mg/day) for 4 weeks. The final week coincided with the 5 assessment timepoints following the eccentric exercise protocol to induce DOMS. |
| G3: Creatina + Omega-3 + NAC + CoQ10 | Experimental | Dietary Supplement: Creatine Monohydrate, Dietary Supplement: Omega 3 FA (Fish Oil), Dietary Supplement: N-Acetyl Cysteine (NAC), Dietary Supplement: Coenzyme Q10 100 MG Oral CapsuleParticipants received creatine monohydrate (5 g/day), omega-3 fish oil (2 capsules/day; 456 mg EPA + 225 mg DHA), N-acetylcysteine (600 mg/day), and coenzyme Q10 (100 mg/day) for 4 weeks. The final week coincided with the 5 assessment timepoints following the eccentric exercise protocol to induce DOMS. |
| G4: Placebo | Experimental | Dietary Supplement: PlaceboParticipants received a placebo consisting of maltodextrin (5 g/day) and olive oil capsules (2 capsules/day), visually identical to the active arms in capsule size, sachet format, and packaging colour, for 4 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female sex
- Age 18-35 years
- Trained status (regular resistance or sport training)
- Enrolled at Universidad Europea de Madrid
- Absence of musculoskeletal injury at time of recruitment
Key exclusion criteria (5 listed)
- History of chronic musculoskeletal or cardiovascular disease
- Use of anti-inflammatory medication or antioxidant supplementation in the prior 4 weeks
- Pregnancy or breastfeeding
- Inability to complete the eccentric exercise protocol
- Non-compliance with supplementation or dietary control requirements
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 |
|---|---|---|
| Creatine MonohydrateCreatine monohydrate administered at 5 g/day for 4 weeks. Used in G1, G2, and G3 arms | Dietary supplement | G1: Creatine + Omega-3, G2: Creatina + Omega-3 + NAC, G3: Creatina + Omega-3 + NAC + CoQ10 |
| Omega 3 FA (Fish Oil)Administered as 2 capsules/day (456 mg EPA + 225 mg DHA per capsule; EPA:DHA ratio 2:1) for 4 weeks. Included in G1, G2, and G3 arms. | Dietary supplement | G1: Creatine + Omega-3, G2: Creatina + Omega-3 + NAC, G3: Creatina + Omega-3 + NAC + CoQ10 |
| N-Acetyl Cysteine (NAC)Administered at 600 mg/day for 4 weeks. Included in G2 and G3 arms. | Dietary supplement | G2: Creatina + Omega-3 + NAC, G3: Creatina + Omega-3 + NAC + CoQ10 |
| Coenzyme Q10 100 MG Oral CapsuleAdministered at 100 mg/day for 4 weeks. Included in G3 arm only. | Dietary supplement | G3: Creatina + Omega-3 + NAC + CoQ10 |
| PlaceboMaltodextrin (5 g/day) and olive oil capsules (2 capsules/day), visually identical to active arms. Administered for 4 weeks in G4 arm. | Dietary supplement | G4: Placebo |
Primary outcome
Countermovement Jump Height (CMJ)
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Assessed using My Jump Lab app (240 fps). Jump height in centimeters as indicator of lower limb neuromuscular performance recovery
Muscle Pain Pressure Threshold
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Assessed using a pressure algometer (BASELINE). Measures the minimum pressure at which the participant perceives pain, expressed in kg/cm²
30- Meter Sprint Time
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Assessed using Witty photocell system (Microgate). Time in seconds to complete a 30-meter sprint.
Creatine Kinase (CK)
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
ssessed using SimplexTAS 101 analyzer. Serum CK activity in U/L as a biochemical marker of muscle damage.
4 secondary outcomes
RIGHT LEG DYNAMOMENTRY
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
LEFT LEG DYNAMOMETRY
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Thermography
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
Heart Rate Variability
Time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the published article, after de-identification, will be made available upon reasonable request to the corresponding author. Data will include all outcome variables assessed at each time point (T1-T5) for all 60 participants. Requests should be directed to the corresponding author and will be considered on a case-by-case basis following publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate, Omega 3 FA (Fish Oil) and N-Acetyl Cysteine (NAC) in people with Delayed Onset Muscle Soreness and Exercise-induced Muscle Damage, run by Antonio Molina Lopez 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 16 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Countermovement Jump Height (CMJ) (time frame: Baseline (Day 0), immediately post-exercise (Day 2), 24 hours after exercise (Day 3), 48 hours after exercise (Day 4), and 72 hours post-eccentric exercise (Day 5)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.