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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02839525
Other study ID # 51384015.5.0000.5345
Secondary ID
Status Completed
Phase N/A
First received July 13, 2016
Last updated March 8, 2017
Start date July 26, 2016
Est. completion date February 9, 2017

Study information

Verified date March 2017
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

The procedures will be performed at the Federal University of Health of Porto Alegre (UFCSPA).


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date February 9, 2017
Est. primary completion date January 9, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omega 3
3000mg of n-3 oil (2000mg EPA e 1000mg DHA)
Isolate whey protein
23g of protein of whey protein
Omega 3 and Isolate whey protein
3000mg of n-3 oil (2000mg EPA e 1000mg DHA) and 23g of protein of whey protein
Other:
Eccentric exercise
100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series

Locations

Country Name City State
Brazil UFCSPA Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). One Year
Secondary Evaluation of quadriceps muscle pain (Muscle pain levels) The assessment of pain as muscle damage marker is expressed by a visual analog scale. One year
Secondary Vastus lateralis and rectus femoris echo intensity Ultrasound images One year
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