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Completed

NCT Number: NCT02115698

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

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.

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Key information

Conditions

Sarcopenia Atrophy Frailty Muscle Loss Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Heavy Resistance Training

Procedure

Supervised Heavy Resistance Training three times weekly for 52 weeks.

Light Intensity Training

Procedure

Home-based Light Intensity Training three-five times weekly for 52 weeks.

Protein Whey

Dietary Supplement

Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Protein Collagen

Dietary Supplement

Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.

Carbohydrate

Dietary Supplement

Two daily 30 g carbohydrate supplementations for 52 weeks.

Primary outcomes

  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.

    Statistical analysis:

    Outcome 1 will be subtracted outcome 2 to calculate the difference FSR at baseline and 12 month respectively. The difference at baseline will be subtracted the difference at 12 month to calculate the delta difference. This delta difference will be analyzed as a modified intention-to-treat as well as per protocol, and we will test the following groups against each other using one-way analysis of variance of the relative group changes from baseline to 12 months: (1) WHEY vs. COLL vs. CARB and (2) HRTW vs. LITW vs. WHEY

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Arla Foods
  • University of Copenhagen

Registry information

Official study title

Counteracting Age-related Loss of Skeletal Muscle Mass

Acronym: CALM

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2014
Registry last updated
Apr 20, 2023

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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