NCT01555775

Brief Summary

The aim of this study is to assess the effect of ingesting a commercial carbohydrate and protein dietary supplement in powder form (P-CHO supplement) or a milk shake with skimmed milk, strawberries and banana (MS), after resistance exercise, in muscle damage, oxidative stress, inflammation and functional recovery. It is hypothesised if the ingestion of a milk shake with skimmed milk and fruit (strawberry and banana) has the same impact on markers of muscle damage, oxidative stress, inflammation and functional recovery induced by resistance exercise, as the intake of a commercial powder with the same CHO and protein amounts. Fifteen adult athletes from the Portuguese Athletic Federation will complete 2 trials separated at least by 2 weeks. Alternate legs and drinks will be used in each trial and participants will be overnight-fasted. This study will have a single-blind, randomized, crossover, repeated-measures experimental design. In each trial, after warm-up, the eccentric peak torque of the knee joint extensors will be determined using an isokinetic dynamometer. After this, participants will complete an isokinetic exercise until exhaustion at a constant angular velocity of 60° • s-1. After the exhaustion protocol, athletes will perform again the peak torque determination. Immediately after, participants will drink the P-CHO supplement or MS during the first 2 h. Both drinks will contain 0.8-1.2 g carbohydrates • kg-1 • h-1 and 0.2-0.4 g protein • kg-1 • h-1. Twenty four and 48 h after the exhaustion protocol participants will return to the laboratory to repeat the peak torque determination. Blood samples will be collected before warming-up, immediately and 2 h after the last peak torque determination and 24 h and 48 h after. Serum samples will be analyzed for creatine kinase, lactate dehydrogenase, interleukine-6, protein carbonyls and total antioxidant status. The delayed onset muscle soreness, using a visual analogue scale, and girths will be measured at the same moments as blood sampling. Two-way repeated-measures ANOVA will be used for statistical analysis of the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

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

Study Start

First participant enrolled

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

March 7, 2012

Last Update Submit

January 15, 2013

Conditions

Keywords

exercise-induced muscle damagenutritional recoverynutritional supplementnatural food

Outcome Measures

Primary Outcomes (8)

  • Maximal peak torque of the knee extensors muscles

    To monitor functional recovery

    Up to 48 h

  • Creatine kinase

    To monitor muscle damage

    Up to 48 h

  • Lactate dehydrogenase

    To monitor muscle damage

    Up to 48 h

  • Interleukine-6

    To monitor the inflammatory process

    Up to 48 h

  • Total antioxidant status

    To monitor oxidative stress

    Up to 48 h

  • Delayed onset muscle soreness

    By a visual analogue scale, 10 cm in length. To monitor muscle soreness

    Up to 48 h

  • Mid-thigh girth, Three other girths will be measured: 5, 15 and 25 cm above the superior border of the patella.

    To monitor the inflammatory process

    Up to 48 h

  • Protein carbonyls

    To monitor oxidative stress

    Up to 48 h

Secondary Outcomes (3)

  • Percentage of body fat

    1 week before the first trial

  • Food records

    2 days before each trial

  • Physical activity records

    2 days before each trial

Study Arms (2)

P-CHO supplement

EXPERIMENTAL

This group will drink the P-CHO supplement in the first trial and the fruit milk shake in the second.

Dietary Supplement: P-CHO supplement

Fruit Milk Sake

EXPERIMENTAL

This group will drink the fruit milk shake in the first trial and the P-CHO supplement in the second.

Dietary Supplement: Fruit Milk Shake

Interventions

P-CHO supplementDIETARY_SUPPLEMENT

In the first trial, this group will drink a protein (P)-carbohydrate (CHO) supplement and in the second trial the fruit milk shake.

Also known as: Available in a common local market.
P-CHO supplement
Fruit Milk ShakeDIETARY_SUPPLEMENT

The fruit content of the milk shake will be 100 g of strawberry and the amount of banana necessary to guaranty 0.8-1.2 g CHO • kg-1 BW • h-1.

Also known as: Strawberry, bananas, skimmed milk
Fruit Milk Sake

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy and lactose tolerant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Desporto, Universidade do Porto

Porto, 4200-450, Portugal

Location

Related Publications (44)

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Related Links

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • José Soares, PhD

    Faculdade de Desporto, Universidade do Porto

    STUDY DIRECTOR
  • Monica V. Sousa, BSc

    Faculdade de Desporto, Universidade do Porto

    PRINCIPAL INVESTIGATOR
  • Vitor H Teixeira, PhD

    Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 15, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations