- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297151
Protein Supplementation and Recovery of Muscle Function
The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise
The focus is performance nutrition. Resistance exercise can induce low level muscle damage in conjunction with impaired contractile function. Milk-derived proteins contain, or induce, bioactive properties that assist muscle recovery and restore/improve muscle function. The aim of the research is the recovery of muscle function following resistance exercise.
In this study, the investigators propose to undertake a comparison of the ingestion of two milk-derived protein-based recovery drinks on muscle function after resistance exercise compares to an isonitrogenous, non-essential amino acid control.
Study Overview
Status
Conditions
Detailed Description
Study Design: A block randomised design of 3 groups of resistance-exercise trained (RET) men
Participants: 24 young, healthy, resistance exercise trained, males aged 18 - 35 years.
Recovery drinks; CONTROL - an isonitrogenous, non-essential amino acid solution; PROTEIN - a milk-based whey protein concentrate (WPC), WPC-80; HYDROLYSATE - a hydrolysed derivative of WPC-80.
Day 1, Pre-screening consisting of:
- medical history and examination by a clinician
- blood sample to be evaluated for health-related contraindications
- body composition measurement by dual energy x-ray absorptiometry (DXA) to determine whole body and segmental lean tissue mass;
- exercise training log (6 month recall);
- dietary consultation;
- habitual physical activity level assessed by European Physical Activity Questionaire (EPAQ)-2
Day 2 - 8: Participants will be "free-living" during this time. Participants will record dietary intake under the guidance of a qualified dietitian and sports nutritionist.
Day 9 and 10: Participants will complete two familiarisation sessions to the resistance exercise and muscle function testing procedures.
A single blood sample (5ml) will be drawn following o/n fast on each day. On day 2 participants will drink a metered dose of deuterated water (around 200ml) containing deuterium. A saliva sample will be taken before and after consuming this bolus.
Day 11-17. During this experimental phase diet is prescribed and provided. The diet is based on habitual food intake standardized to body mass.
Day 11: O/n fasted blood, saliva and 1st micro-biopsy of muscle obtained; Muscle function measured prior to and upon completion of a prescribed bout of resistance exercise training (RET); The recovery drink (0.33 g protein/kg body mass) is ingested; 3 hours following completion of RET a 2nd micro-biopsy of muscle is obtained.
Day 12: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.
Day 13: O/n fasted blood and saliva is obtained Muscle function measured followed by the 2nd RET bout and recovery drink (0.33 g protein/kg body mass) consumed.
Day 14: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.
Day 15: O/n fasted blood and saliva is obtained Muscle function measured followed by the 3rd RET bout and recovery drink (0.33 g protein/kg body mass) consumed.
Day 16 O/n fasted blood, saliva and 3rd micro-biopsy of muscle obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.
Day 17: O/n fasted blood and saliva is obtained Muscle function measured
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Co Limerick
-
Limerick, Co Limerick, Ireland
- Recruiting
- University of Limerick
-
Contact:
- Philip Jakeman, PhD
- Phone Number: +35361202800
- Email: phil.jakeman@ul.ie
-
Contact:
- Dick Fitzgerald, PhD
- Phone Number: +35361202598
- Email: dick.fitzgerald@ul.ie
-
Sub-Investigator:
- Dick Fitzgerald, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- risk
- no known current illness or physically active
- resistance-exercise trained
- no known intolerance to milk-based products
- no known blood born disease or medication that would adversely affect participation
- no adverse risk to venepuncture
Exclusion Criteria:
• recent musculoskeletal injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: CONTROL
Intervention: Dietary Supplement: Non-essential amino acids A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g non-essential amino acids dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session. Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy. |
Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water. Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955 |
ACTIVE_COMPARATOR: PROTEIN
Intervention: Dietary Supplement: Whey Protein Concentrate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Concentrate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session. Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy. |
Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water. Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431
Other Names:
|
ACTIVE_COMPARATOR: HYDROLYSATE
Intervention: Dietary Supplement: Whey Protein Hydrolysate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Hydrolysate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session. Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy. |
Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water. Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Muscle Contractile Function
Time Frame: Day 9, 10, 11, 12, 13, 14, 15, 16 and 17
|
Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry
|
Day 9, 10, 11, 12, 13, 14, 15, 16 and 17
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Muscle Protein Synthesis
Time Frame: Day 11 and 16
|
The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy
|
Day 11 and 16
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FHIHAPN3.3RX
- TC20130001 (OTHER_GRANT: Enterprise Ireland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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