Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-04-22 @ 12:54 AM
Study NCT ID:
NCT03297151
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2017-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Supplementation and Recovery of Muscle Function
Sponsor:
University of Limerick
Organization:
Study Overview
Official Title:
The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TC20130001 | OTHER_GRANT | Enterprise Ireland | View |