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Clinical Trials/NCT03299972
NCT03299972CompletedNot Applicable

Effects of 12 Weeks Resistance Exercise and Whey Protein Supplementation on Energy Metabolism, Appetite, Body Composition and Biomarkers Related to Sarcopenia and Metabolic Health

Coventry University2 sites in 1 country39 target enrollmentStarted: October 27, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
2
Primary Endpoint
Changes in 24-h substrate oxidation (g/d)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Whey Protein

Experimental

Intervention: Whey Protein (Dietary Supplement)

Control

Placebo Comparator

Intervention: Control (Dietary Supplement)

Resistance Exercise + Control

Experimental

Intervention: Control (Dietary Supplement)

Resistance Exercise + Control

Experimental

Intervention: Resistance Exercise (Other)

Resistance Exercise + Whey Protein

Experimental

Intervention: Resistance Exercise (Other)

Resistance Exercise + Whey Protein

Experimental

Intervention: Whey Protein (Dietary Supplement)

Outcomes

Primary Outcomes

Changes in 24-h substrate oxidation (g/d)

Time Frame: 0 to 12 weeks

Measured by whole-room calorimetry

Changes in components of 24-h energy expenditure and its components (kcal/d)

Time Frame: 0 to 12 weeks

Measured by whole-room calorimetry

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

Secondary Outcomes

  • Biochemical: Appetite hormones(0 to 12 weeks)
  • Isotonic Strength (kg) - Leg press and leg extension(0 to 12 weeks)
  • Biochemical: Myostatin(0 to 12 weeks)
  • Biochemical: Inflammtion(0 to 12 weeks)
  • Interstitial Glucose(0 to 12 weeks)
  • Biochemical: Insulin Resistance (HOMAR-IR)(0 to 12 weeks)
  • Salivary:Diurnal Cortisol(0 to 12 weeks)
  • Biochemical: Insulin-Like Growth Factor 1 (IGF-1)(0 to 12 weeks)
  • Handgrip strength (kg)(0 to 12 weeks)
  • Endurance (Six Minute Walk Test)(0 to 12 weeks)
  • Short Physical Performance Battery (SPPB)(0 to 12 weeks)
  • Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery(0 to 12 weeks)
  • Habitual Physical Activity(0 to 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Corbin Griffen

Principle Investigator

Coventry University

Study Sites (2)

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