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Counteracting Age-related Loss of Skeletal Muscle Mass (CALM) (CALM)

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ClinicalTrials.gov Identifier: NCT02115698
Recruitment Status : Recruiting
First Posted : April 16, 2014
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
University of Copenhagen
Arla Foods
Information provided by (Responsible Party):
Lars Holm, Bispebjerg Hospital

Brief Summary:

Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They will be recruited as a subgroup to protocol ID: H-4-2013-070.

Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content.

Assessments will be performed at Baseline (before intervention start) and after 12 months of intervention.

The primary outcomes are measures of muscle protein synthesis rate measured as the fractional synthesis rate from Baseline to 12 months of intervention.

The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are elevated in the exercise training groups after 12 months of intervention. ii) prolonged intake of protein of different quality will improve the muscle protein synthetic response to protein intake after 12 months of intervention.


Condition or disease Intervention/treatment Phase
Sarcopenia Muscle Loss Procedure: Heavy Resistance Training Procedure: Light Intensity Training Dietary Supplement: Protein Whey Dietary Supplement: Protein Collagen Dietary Supplement: Carbohydrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Counteracting Age-related Loss of Skeletal Muscle Mass
Actual Study Start Date : April 1, 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Active Comparator: Heavy Resistance Training
Heavy Resistance Training of the lower extremities three times weekly in combination with two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
Procedure: Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 52 weeks.

Dietary Supplement: Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Experimental: Light Intensity Training
Home-based Light Intensity Training of the lower extremities three-five times weekly in combination with two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
Procedure: Light Intensity Training
Home-based Light Intensity Training three-five times weekly for 52 weeks.

Dietary Supplement: Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Active Comparator: Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
Dietary Supplement: Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Active Comparator: Protein Collagen
Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.
Dietary Supplement: Protein Collagen
Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.

Placebo Comparator: Carbohydrate
Two daily 30 g carbohydrate supplementations for 52 weeks.
Dietary Supplement: Carbohydrate
Two daily 30 g carbohydrate supplementations for 52 weeks.




Primary Outcome Measures :
  1. Basal overnight fasted muscle protein synthesis rate. [ Time Frame: Baseline and 12 months ]
    Overnight fasting muscle protein synthesis will be measured at Baseline and after 12 months intervention by applying stable isotope amino acid tracer techniques and calculating the fractional synthesis rates.

  2. Muscle protein synthesis rate response to protein intake from basal overnight fasted state. [ Time Frame: Baseline and 12 months ]
    Change in the response of muscle protein synthesis rate to a single intake of 20 g whey protein and 10 g carbohydrate from the basal overnight fasted state from Baseline to 12 months intervention.


Secondary Outcome Measures :
  1. Muscle protein turnover molecular signaling and gene expression [ Time Frame: Baseline and 12 months ]
    Muscle protein turnover regulation signaling and gene expression will be measured in the muscle tissue obtained for muscle protein synthesis measurements. Protein and protein activation status will be analysed by Western blot techniques. Gene expressions will be analysed by real time RT-PCR techniques.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, independently living
  • Age at least 65 years

Exclusion Criteria:

  • Subjects dependent on help/nursing etc.
  • Chronic medical diseases: diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia
  • Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens
  • Implanted magnetic devices incompatible with MRi-scanning
  • Weekly alcohol consumption > 21 units (1 unit equals 4 g of ethanol) for men and > 14 for women
  • Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40 mg/day or if combined with subjective myalgia, ACE-inhibitors, angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparring diuretics and loop diuretics
  • 1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation

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): NCT02115698


Contacts
Contact: Jacob L. Bülow, MD +45 38 35366 jacob.bulow@live.dk
Contact: Søren Reitelseder, PhD +45 38 35366 s.reitelseder@gmail.com

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen NV, Denmark, 2400
Contact: Jacob Bülow, MD    +45 38 35366    jacob.bulow@live.dk   
Contact: Søren Reitelseder, PhD    +45 38 35366    s.reitelseder@gmail.com   
Principal Investigator: Jacob Bülow, MD         
Sub-Investigator: Lars Holm, PhD, MS         
Sub-Investigator: Søren Reitelseder, PhD, MS         
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
Arla Foods
Investigators
Principal Investigator: Rasmus L. Bechshoeft, MD Bispebjerg Hospital
Principal Investigator: Lars Holm, assoc. prof. Bispebjerg Hospital
Principal Investigator: Michael Kjaer, MD, prof. Bispebjerg Hospital
Principal Investigator: Søren Reitelseder, PhD Bispebjerg Hospital
Principal Investigator: Jacob Bülow, MD PhD stud Bispebjerg Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Holm, PhD, MS, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02115698     History of Changes
Other Study ID Numbers: H-4-2013-070.3
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Lars Holm, Bispebjerg Hospital:
Sarcopenia
Frailty
Ageing
Protein supplementation
Protein quality
Exercise training
Muscle protein turnover

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms