- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839525
The Effect of Nutritional Interventions on Exercise-induced Muscle Damage
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- UFCSPA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 - 40 years aged
- BMI 18,5-25kg/m2
- physical exercise: < 150 minutes per week
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Omega 3
|
3000mg of n-3 oil (2000mg EPA e 1000mg DHA)
100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series
|
PLACEBO_COMPARATOR: Isolate whey protein
|
100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series
23g of protein of whey protein
|
PLACEBO_COMPARATOR: Omega 3 and Isolate whey protein
|
100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series
3000mg of n-3 oil (2000mg EPA e 1000mg DHA) and 23g of protein of whey protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
One Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of quadriceps muscle pain (Muscle pain levels)
Time Frame: One year
|
The assessment of pain as muscle damage marker is expressed by a visual analog scale.
|
One year
|
Vastus lateralis and rectus femoris echo intensity
Time Frame: One year
|
Ultrasound images
|
One year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Claudia Dornelles Schneider, Doctor, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 51384015.5.0000.5345
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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