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

Bispebjerg Hospital

Status: Completed

Conditions: Muscle Loss; Sarcopenia

Treatments: Dietary Supplement: Protein Collagen; Procedure: Light Intensity Training; Dietary Supplement: Carbohydrate; Procedure: Heavy Resistance Training; Dietary Supplement: Protein Whey

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02115698

H-4-2013-070.3

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 5 patient groups, including a placebo group

Heavy Resistance Training

Active Comparator group

Description:

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.

Treatment:

Procedure: Heavy Resistance Training

Dietary Supplement: Protein Whey

Light Intensity Training

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Protein Whey

Procedure: Light Intensity Training

Protein Whey

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Protein Whey

Protein Collagen

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Protein Collagen

Carbohydrate

Placebo Comparator group

Description:

Two daily 30 g carbohydrate supplementations for 52 weeks.

Treatment:

Dietary Supplement: Carbohydrate