Muscle DamageNCT02839525
The Effect of Nutritional Interventions on Exercise-induced Muscle Damage
A study testing Omega 3, Isolate whey protein and Omega 3 and Isolate whey protein in people with Muscle Damage, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional strategies that help to minimize the effects of muscle damage induced by exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Omega 3, Isolate whey protein and Omega 3 and Isolate whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jul 2016to 9 Feb 2017
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 40 years aged
- BMI 18,5-25kg/m2
- physical exercise: < 150 minutes per week
Who cannot join
- pregnancy/ lactation
- vegetarian/vegan
- chronic disease
- pulmonary and neurologic disease
- muscle injury/knee muscle injury
- medication use: anti-inflammatory and anticoagulant
- fish oil and derivate allergy
- dietary supplements use in the last month: whey protein, casein, albumin, glutamin, meat and soy protein, creatine, branched chain amino acid, high calorie supplement, n-3 supplement and antioxidants
Trial locations and contacts
1 site in 1 country.
About this study
The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional strategies that help to minimize the effects of muscle damage induced by exercise.
The procedures will be performed at the Federal University of Health of Porto Alegre (UFCSPA).
Read the detailed description
The exercise-induced muscle damage is associated with eccentric activities affecting muscle structural unit through micro-injury that can promote a local inflammatory response, muscle damage and delayed onset muscle soreness. These events can cause an impact on athletic performance and lower adherence to the training programs. To optimize muscle recovery after the damage caused by exercise is essential to ensure adequate caloric intake , with required amounts of macronutrients and micronutrients. Recent studies have been showed that the protein intake before sleeping is a effective strategy to inhibit muscle protein degradation, stimulate muscle protein synthesis and facilitate adaptive response of skeletal muscle to physical exercise. Furthermore, evidences on the use of anti-inflammatory nutrients have suggested that diets rich in omega 3 can reduce inflammation through inhibition of pro-inflammatory mediators. Therefore, the intake of this nutrient combined with a protein meal before sleeps and the control of food intake can improve adherence to sports training. The study will consist of three groups where everyone will receive an individualized diet. A randomization procedure will determine the type of intervention. The distribution of the groups will be as follows: group 1 (control) - volunteers follow individualized diet and olive oil capsules and maltodextrin; group 2 - intervention with omega 3 more individualized diet ; group 3 - omega 3 and whey protein isolate intervention more individualized diet.
The order of procedures to be performed will be: (1) Nutritional and Anthropometric assessment; (2) Individual orientation of diet and distribution of supplements; (3) Baseline assessment (peak torque, muscle pain levels and vastus lateralis and rectus femoris echo intensity; (4) Muscle damage induction by eccentric exercise protocol; (5) Reviews after 24h, 48h, 72h, which will follow the routine and the methods applied at baseline.
- Conditions
- Muscle Damage
- Being tested
- Omega 3, Isolate whey protein, Omega 3 and Isolate whey protein, Eccentric exercise
- Keywords
- Eccentric exercise, Dietary supplement, Muscle damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Dietary supplement
3000mg of n-3 oil (2000mg EPA e 1000mg DHA)
Isolate whey proteinDietary supplement
23g of protein of whey protein
Omega 3 and Isolate whey proteinDietary supplement
3000mg of n-3 oil (2000mg EPA e 1000mg DHA) and 23g of protein of whey protein
Eccentric exerciseOther
100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 | Placebo comparator | * 3000mg of olive oil
* Eccentric exercise: 100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series Receives: Dietary Supplement: Omega 3; Other: Eccentric exercise |
| Isolate whey protein | Placebo comparator | * 23g of maltodextrin
* Eccentric exercise: 100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series Receives: Dietary Supplement: Isolate whey protein; Other: Eccentric exercise |
| Omega 3 and Isolate whey protein | Placebo comparator | * 3000mg of olive oil and 23g of maltodextrin
* Eccentric exercise: 100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series Receives: Dietary Supplement: Omega 3 and Isolate whey protein; Other: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength evaluation (Peak Torque)
Three maximal isometric contractions of knee extensors will be performed by the isokinetic dynamometer equipment Biodex System 4 Pro (Biodex Medical Systems, USA).
Measured: One Year
Secondary outcomes (2)
Evaluation of quadriceps muscle pain (Muscle pain levels)
The assessment of pain as muscle damage marker is expressed by a visual analog scale.
Measured: One year
Vastus lateralis and rectus femoris echo intensity
Ultrasound images
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start26 Jul 2016
- Primary completion9 Jan 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Letícia Chisini Loss, Federal University of Health Science of Porto Alegre
- Investigators
- Claudia Dornelles Schneider, Doctor, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839525
- Sponsor's protocol ID
- 51384015.5.0000.5345
- Status last verified
- Mar 2017
- First submitted
- 13 Jul 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutritional Interventions on Exercise-induced Muscle Damage
- ClinicalTrials.gov ID
- NCT02839525
- Acronym / sponsor ID
- 51384015.5.0000.5345
- Conditions
- Muscle Damage
- Keywords
- Eccentric exercise, Dietary supplement, Muscle damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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 is a randomized, double-blinded, placebo-controlled trial that will include the participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional strategies that help to minimize the effects of muscle damage induced by exercise.
The procedures will be performed at the Federal University of Health of Porto Alegre (UFCSPA).
Detailed description
The exercise-induced muscle damage is associated with eccentric activities affecting muscle structural unit through micro-injury that can promote a local inflammatory response, muscle damage and delayed onset muscle soreness. These events can cause an impact on athletic performance and lower adherence to the training programs. To optimize muscle recovery after the damage caused by exercise is essential to ensure adequate caloric intake , with required amounts of macronutrients and micronutrients. Recent studies have been showed that the protein intake before sleeping is a effective strategy to inhibit muscle protein degradation, stimulate muscle protein synthesis and facilitate adaptive response of skeletal muscle to physical exercise. Furthermore, evidences on the use of anti-inflammatory nutrients have suggested that diets rich in omega 3 can reduce inflammation through inhibition of pro-inflammatory mediators. Therefore, the intake of this nutrient combined with a protein meal before sleeps and the control of food intake can improve adherence to sports training. The study will consist of three groups where everyone will receive an individualized diet. A randomization procedure will determine the type of intervention. The distribution of the groups will be as follows: group 1 (control) - volunteers follow individualized diet and olive oil capsules and maltodextrin; group 2 - intervention with omega 3 more individualized diet ; group 3 - omega 3 and whey protein isolate intervention more individualized diet.
The order of procedures to be performed will be: (1) Nutritional and Anthropometric assessment; (2) Individual orientation of diet and distribution of supplements; (3) Baseline assessment (peak torque, muscle pain levels and vastus lateralis and rectus femoris echo intensity; (4) Muscle damage induction by eccentric exercise protocol; (5) Reviews after 24h, 48h, 72h, which will follow the routine and the methods applied at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omega 3 | Placebo comparator | Dietary Supplement: Omega 3, Other: Eccentric exercise* 3000mg of olive oil * Eccentric exercise: 100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series |
| Isolate whey protein | Placebo comparator | Dietary Supplement: Isolate whey protein, Other: Eccentric exercise* 23g of maltodextrin * Eccentric exercise: 100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series |
| Omega 3 and Isolate whey protein | Placebo comparator | Dietary Supplement: Omega 3 and Isolate whey protein, Other: Eccentric exercise* 3000mg of olive oil and 23g of maltodextrin * Eccentric exercise: 100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 - 40 years aged
- BMI 18,5-25kg/m2
- physical exercise: < 150 minutes per week
Key exclusion criteria (8 listed)
- pregnancy/ lactation
- vegetarian/vegan
- chronic disease
- pulmonary and neurologic disease
- muscle injury/knee muscle injury
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 |
|---|---|---|
| Omega 33000mg of n-3 oil (2000mg EPA e 1000mg DHA) | Dietary supplement | Omega 3 |
| Isolate whey protein23g of protein of whey protein | Dietary supplement | Isolate whey protein |
| Omega 3 and Isolate whey protein3000mg of n-3 oil (2000mg EPA e 1000mg DHA) and 23g of protein of whey protein | Dietary supplement | Omega 3 and Isolate whey protein |
| Eccentric exercise100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series | Other | Isolate whey protein, Omega 3, Omega 3 and Isolate whey protein |
Primary outcome
Quadriceps muscle strength evaluation (Peak Torque)
Time frame: One Year
Three maximal isometric contractions of knee extensors will be performed by the isokinetic dynamometer equipment Biodex System 4 Pro (Biodex Medical Systems, USA).
2 secondary outcomes
Evaluation of quadriceps muscle pain (Muscle pain levels)
Time frame: One year
Vastus lateralis and rectus femoris echo intensity
Time frame: One year
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 9 Mar 2017.
- Individual participant dataSharing planned: Yes
Related trials for Muscle Damage
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
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.
Claudia Dornelles Schneider, Doctor principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3, Isolate whey protein and Omega 3 and Isolate whey protein in people with Muscle Damage, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 3 inclusion and 8 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 9 Mar 2017. 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 Brazil. 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.
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?
Quadriceps muscle strength evaluation (Peak Torque) (time frame: One Year). 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 9 Mar 2017.