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Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men

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: NCT03299972
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
University Hospitals Coventry and Warwickshire NHS Trust
Information provided by (Responsible Party):
Corbin Griffen, Coventry University

Study Description
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Brief Summary:

The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance.

Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). Participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.


Condition or disease Intervention/treatment Phase
Sarcopenia Muscle Atrophy Dietary Supplement: Whey Protein Dietary Supplement: Control Other: Resistance Exercise Not Applicable

Detailed Description:
With demographics indicating that the world's population aged >60 years will increase from 600 million reported in 2000, to >2 billion by 2050, there is an increasing interest in health issues related to ageing. One area of particular interest is sarcopenia, defined as the progressive loss of muscle mass, strength and physical function as a consequence of ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor metabolic and cognitive function, reduced quality of life and early mortality. Studies have reported beneficial effects of both resistance exercise and increasing protein intake independently and in combination on markers of sarcopenia (mostly increases in muscle mass, strength and physical function). However, little is known about the effects of combined intervention on energy metabolism, appetite and cognitive and endocrine function. This randomised, double-blind, placebo-controlled, parallel groups trial will investigate these, alongside assessing the effects of combined intervention on total lean tissue mass, muscular strength and functional performance.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of 12 Weeks Resistance Exercise and Whey Protein Supplementation on Energy Metabolism, Appetite, Body Composition and Biomarkers Related to Sarcopenia and Metabolic Health
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Dietary Supplement: Control
23.75 g maltodextrin twice daily (breakfast and lunch)
Experimental: Whey Protein Dietary Supplement: Whey Protein
25 g whey protein supplementation twice daily (breakfast and lunch)
Experimental: Resistance Exercise + Control Dietary Supplement: Control
23.75 g maltodextrin twice daily (breakfast and lunch)

Other: Resistance Exercise
60 minutes of resistance exercise twice a week
Experimental: Resistance Exercise + Whey Protein Dietary Supplement: Whey Protein
25 g whey protein supplementation twice daily (breakfast and lunch)

Other: Resistance Exercise
60 minutes of resistance exercise twice a week


Outcome Measures
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Primary Outcome Measures :
  1. Changes in components of 24-h energy expenditure and its components (kcal/d) [ Time Frame: 0 to 12 weeks ]
    Measured by whole-room calorimetry

  2. Changes in body composition (kg) [ Time Frame: 0 to 12 weeks ]
    Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis

  3. Changes in 24-h substrate oxidation (g/d) [ Time Frame: 0 to 12 weeks ]
    Measured by whole-room calorimetry


Secondary Outcome Measures :
  1. Biochemical: Appetite hormones [ Time Frame: 0 to 12 weeks ]
    Ghrelin, leptin, and PYY

  2. Biochemical: Insulin Resistance (HOMAR-IR) [ Time Frame: 0 to 12 weeks ]
  3. Salivary:Diurnal Cortisol [ Time Frame: 0 to 12 weeks ]
  4. Biochemical: Inflammtion [ Time Frame: 0 to 12 weeks ]
    Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1

  5. Interstitial Glucose [ Time Frame: 0 to 12 weeks ]
    24 Hour Continuous Glucose Monitoring

  6. Biochemical: Insulin-Like Growth Factor 1 (IGF-1) [ Time Frame: 0 to 12 weeks ]
  7. Isotonic Strength (kg) - Leg press and leg extension [ Time Frame: 0 to 12 weeks ]
  8. Short Physical Performance Battery (SPPB) [ Time Frame: 0 to 12 weeks ]
    Balance, Gait speed and time to sit and stand from a chair 5 times

  9. Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery [ Time Frame: 0 to 12 weeks ]
  10. Handgrip strength (kg) [ Time Frame: 0 to 12 weeks ]
  11. Biochemical: Myostatin [ Time Frame: 0 to 12 weeks ]
  12. Habitual Physical Activity [ Time Frame: 0 to 12 weeks ]
    Accelerometer

  13. Endurance (Six Minute Walk Test) [ Time Frame: 0 to 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Retired Men aged 60-80 years
  • Body Mass Index 18.5-30 kg/m2
  • Not participated in resistance exercise within the last 6 months
  • Free from musculoskeletal injury

Exclusion Criteria:

  • Retired Men aged <60 or >80 years
  • Current smokers, or ex-smokers ceasing <6 months ago
  • Body Mass Index <18.5 and >30 kg/m2
  • Currently participating in resistance exercise regularly (within last 6 months)
  • Not weight stable and/or looking to start a weight loss programme
  • Individuals participating in another research project (within the last 6 months) involving dietary and/or exercise intervention
  • Existing or past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, osteoporosis or history of falls
  • Currently taking protein/amino acid supplements regularly
  • Currently prescribed non-steroidal anti-inflammatory medication, hormone replacement therapy (HRT), diabetic medication, beta-blockers, statins
  • Uncontrolled blood pressure (Blood pressure >160/100 mmHg)
  • Self-reported lactose intolerant or allergic to wheat or potatoes
  • Individuals with a pacemaker
  • Neuromuscular disorders or injuries
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299972


Locations
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United Kingdom
Coventry University
Coventry, West Midlands, United Kingdom, CV1 5FB
Sponsors and Collaborators
Coventry University
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
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Study Director: Derek Renshaw, PhD Coventry University
Study Director: John Hattersley, PhD University Hosptials Coventry and Warwickshire NHS Trust
Study Director: Michael Duncan, PhD Coventry University
Principal Investigator: Corbin Griffen, MSc Coventry University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corbin Griffen, Principle Investigator, Coventry University
ClinicalTrials.gov Identifier: NCT03299972    
Other Study ID Numbers: P59723
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Corbin Griffen, Coventry University:
Sarcopenia
Resistance exercise
Protein
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
 Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases