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CompletedNCT02839525Updated Mar 9, 2017

The Effect of Nutritional Interventions on Exercise-induced Muscle Damage

An interventional study of Omega 3 and Isolate whey protein in Muscle Damage, sponsored by Federal University of Health Science of Porto Alegre. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-09.

Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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).

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.

02

Conditions studied

  • Muscle Damage

Keywords

  • Eccentric exercise
  • Dietary supplement
  • Muscle damage
03

In context

Lead sponsor

Federal University of Health Science of Porto Alegre is the lead sponsor of 118 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 - 40 years aged
  • BMI 18,5-25kg/m2
  • physical exercise: \< 150 minutes per week

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2 participants (actual)

Study arms

  • Placebo comparator
    Omega 3

    * 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

    Dietary Supplement: Omega 3 · Other: Eccentric exercise

  • Placebo comparator
    Isolate whey protein

    * 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

    Dietary Supplement: Isolate whey protein · Other: Eccentric exercise

  • Placebo comparator
    Omega 3 and Isolate whey protein

    * 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

    Dietary Supplement: Omega 3 and Isolate whey protein · Other: Eccentric exercise

Interventions

  • Dietary supplementOmega 3

    3000mg of n-3 oil (2000mg EPA e 1000mg DHA)

  • Dietary supplementIsolate whey protein

    23g of protein of whey protein

  • Dietary supplementOmega 3 and Isolate whey protein

    3000mg of n-3 oil (2000mg EPA e 1000mg DHA) and 23g of protein of whey protein

  • OtherEccentric exercise

    100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: One Year

Secondary outcomes

  1. Evaluation of quadriceps muscle pain (Muscle pain levels)

    The assessment of pain as muscle damage marker is expressed by a visual analog scale.

    Time frame: One year

  2. Vastus lateralis and rectus femoris echo intensity

    Ultrasound images

    Time frame: One year

07

Study locations

1 site
  • UFCSPA
    Porto Alegre, Rio Grande do Sul 90050-170, Brazil
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02839525
Lead sponsor
Federal University of Health Science of Porto Alegre
Responsible party
Letícia Chisini Loss (Principal Investigator, Federal University of Health Science of Porto Alegre) — Principal investigator
First posted
Jul 21, 2016
Start date
Jul 26, 2016
Primary completion
Jan 9, 2017
Completion
Feb 9, 2017
Last update
Mar 9, 2017

Study contacts

Claudia Dornelles Schneider, Doctor
principal investigator · Federal University of Health Science of Porto Alegre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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