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

Primary Purpose

Sarcopenia, Muscle Atrophy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whey Protein
Control
Resistance Exercise
Sponsored by
Coventry University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Resistance exercise, Protein

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Coventry University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control

Whey Protein

Resistance Exercise + Control

Resistance Exercise + Whey Protein

Arm Description

Outcomes

Primary Outcome Measures

Changes in components of 24-h energy expenditure and its components (kcal/d)
Measured by whole-room calorimetry
Changes in body composition (kg)
Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
Changes in 24-h substrate oxidation (g/d)
Measured by whole-room calorimetry

Secondary Outcome Measures

Biochemical: Appetite hormones
Ghrelin, leptin, and PYY
Biochemical: Insulin Resistance (HOMAR-IR)
Salivary:Diurnal Cortisol
Biochemical: Inflammtion
Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1
Interstitial Glucose
24 Hour Continuous Glucose Monitoring
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
Isotonic Strength (kg) - Leg press and leg extension
Short Physical Performance Battery (SPPB)
Balance, Gait speed and time to sit and stand from a chair 5 times
Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
Handgrip strength (kg)
Biochemical: Myostatin
Habitual Physical Activity
Accelerometer
Endurance (Six Minute Walk Test)

Full Information

First Posted
September 11, 2017
Last Updated
July 24, 2019
Sponsor
Coventry University
Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03299972
Brief Title
Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coventry University
Collaborators
University Hospitals Coventry and Warwickshire NHS Trust

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Muscle Atrophy
Keywords
Sarcopenia, Resistance exercise, Protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Whey Protein
Arm Type
Experimental
Arm Title
Resistance Exercise + Control
Arm Type
Experimental
Arm Title
Resistance Exercise + Whey Protein
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein
Intervention Description
25 g whey protein supplementation twice daily (breakfast and lunch)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
23.75 g maltodextrin twice daily (breakfast and lunch)
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
60 minutes of resistance exercise twice a week
Primary Outcome Measure Information:
Title
Changes in components of 24-h energy expenditure and its components (kcal/d)
Description
Measured by whole-room calorimetry
Time Frame
0 to 12 weeks
Title
Changes in body composition (kg)
Description
Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
Time Frame
0 to 12 weeks
Title
Changes in 24-h substrate oxidation (g/d)
Description
Measured by whole-room calorimetry
Time Frame
0 to 12 weeks
Secondary Outcome Measure Information:
Title
Biochemical: Appetite hormones
Description
Ghrelin, leptin, and PYY
Time Frame
0 to 12 weeks
Title
Biochemical: Insulin Resistance (HOMAR-IR)
Time Frame
0 to 12 weeks
Title
Salivary:Diurnal Cortisol
Time Frame
0 to 12 weeks
Title
Biochemical: Inflammtion
Description
Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1
Time Frame
0 to 12 weeks
Title
Interstitial Glucose
Description
24 Hour Continuous Glucose Monitoring
Time Frame
0 to 12 weeks
Title
Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
Time Frame
0 to 12 weeks
Title
Isotonic Strength (kg) - Leg press and leg extension
Time Frame
0 to 12 weeks
Title
Short Physical Performance Battery (SPPB)
Description
Balance, Gait speed and time to sit and stand from a chair 5 times
Time Frame
0 to 12 weeks
Title
Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
Time Frame
0 to 12 weeks
Title
Handgrip strength (kg)
Time Frame
0 to 12 weeks
Title
Biochemical: Myostatin
Time Frame
0 to 12 weeks
Title
Habitual Physical Activity
Description
Accelerometer
Time Frame
0 to 12 weeks
Title
Endurance (Six Minute Walk Test)
Time Frame
0 to 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Renshaw, PhD
Organizational Affiliation
Coventry University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Hattersley, PhD
Organizational Affiliation
University Hosptials Coventry and Warwickshire NHS Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Duncan, PhD
Organizational Affiliation
Coventry University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Corbin Griffen, MSc
Organizational Affiliation
Coventry University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coventry University
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV1 5FB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34896568
Citation
Griffen C, Duncan M, Hattersley J, Weickert MO, Dallaway A, Renshaw D. Effects of resistance exercise and whey protein supplementation on skeletal muscle strength, mass, physical function, and hormonal and inflammatory biomarkers in healthy active older men: a randomised, double-blind, placebo-controlled trial. Exp Gerontol. 2022 Feb;158:111651. doi: 10.1016/j.exger.2021.111651. Epub 2021 Dec 9.
Results Reference
derived

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

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