NCT02839525

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

July 26, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

July 13, 2016

Last Update Submit

March 8, 2017

Conditions

Muscle Damage

Keywords

Eccentric exerciseDietary supplementMuscle damage

Outcome Measures

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).

    One Year

Secondary Outcomes (2)

  • Evaluation of quadriceps muscle pain (Muscle pain levels)

    One year

  • Vastus lateralis and rectus femoris echo intensity

    One year

Study Arms (3)

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

Dietary Supplement: Omega 3Other: 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

Dietary Supplement: Isolate whey proteinOther: 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

Dietary Supplement: Omega 3 and Isolate whey proteinOther: Eccentric exercise

Interventions

Omega 3DIETARY_SUPPLEMENT

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

Omega 3
Isolate whey proteinDIETARY_SUPPLEMENT

23g of protein of whey protein

Isolate 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

Omega 3 and Isolate 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

Isolate whey proteinOmega 3Omega 3 and Isolate whey protein

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFCSPA

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Claudia Dornelles Schneider, Doctor

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 21, 2016

Study Start

July 26, 2016

Primary Completion

January 9, 2017

Study Completion

February 9, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

BR(1)