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Completed

NCT Number: NCT03299972

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Coventry University

Coventry, West Midlands, CV1 5FB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

25 g whey protein supplementation twice daily (breakfast and lunch)

Control

Dietary Supplement

23.75 g maltodextrin twice daily (breakfast and lunch)

Resistance Exercise

Other

60 minutes of resistance exercise twice a week

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Coventry University

Other

Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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