Protein Supplementation and Recovery of Muscle Function

Resistance Training Clinical Trial

Official title:

The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297151
• Other study ID #: FHIHAPN3.3RX
• Secondary ID: TC20130001
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2017
• Last updated: September 25, 2017
• Start date: July 1, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: September 2017
• Source: University of Limerick
• Contact: Philip M Jakeman, PhD
• Phone: +35361202800
• Email: phil.jakeman[@]ul.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Damage
• Resistance Training

Intervention

Dietary Supplement:
• CONTROL
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
• Whey Protein Concentrate
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
• Whey Protein Hydrolysate
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

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick	Co Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle Contractile Function	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	Change in Muscle Protein Synthesis	The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy	Day 11 and 16

External Links

•   Food For Health Ireland National Technology Centre