Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protein Ingestion Before Training Low

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03147001
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
Arla Foods
Team Denmark
Innovation Fund Denmark
Information provided by (Responsible Party):
Mette Hansen, University of Aarhus

Brief Summary:
A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0, 60 and 180 min after the training session biopsies are collected.

Condition or disease Intervention/treatment Phase
Protein Metabolism Other: Protein ingestion Other: Non-caloric placebo ingestion Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Masking was done by providing similar tasting drinks at both trails. One was placebo, one was protein a drink
Primary Purpose: Health Services Research
Official Title: Nutritional Strategies for Optimizing Adaptations and Recovery Following Training 'Low'.
Actual Study Start Date : April 30, 2016
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : January 10, 2017

Arm Intervention/treatment
Experimental: Protein ingestion
Subjects ingested protein drinks
Other: Protein ingestion
A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).

Placebo Comparator: Placebo
Subjects ingested a non-caloric placebo drink
Other: Non-caloric placebo ingestion
A placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).




Primary Outcome Measures :
  1. Muscle protein fractional synthetic rate (FSR) [ Time Frame: FSR was measure over at time period of six hours ]

Secondary Outcome Measures :
  1. Tracer kinetics dilution model [ Time Frame: six hours ]
    A-V tracer dilution model was applied across the forearm.

  2. Muscle signalling [ Time Frame: Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise. ]
    Muscle signalling will be determined using western blotting in each muscle biopsy

  3. Nitrogen excretion [ Time Frame: Urine is collected during two periods. Collection period one: 12 hours prior to morning exercise. Collection period 2: During and four hours following exercise. Blood samples is drawn repeatedly from before to four hours after exercise. ]
    nitrogen excretion is determined by Plasma and urinary carbide analysis as well as plasma NH4+.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy well-trained triathletes or cyclists
  • VO2max > 55 ml O2/kg/min
  • Training and has been training more than 7 times a week the last 6 months.

Exclusion Criteria:

  • VO2max < 55 ml O2/kg/min
  • Has chronic disease
  • has incjected with tracer on a previous occasion.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mette Hansen, Assistant professor, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT03147001    
Other Study ID Numbers: 50968
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mette Hansen, University of Aarhus:
Endurance exercise
Dietary protein