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

Bispebjerg Hospital

Status: Completed

Conditions: Muscle Loss; Sarcopenia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02034760

H-4-2013-070

Details and patient eligibility

About

Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects.

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=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50), Protein Collagen (N=40-50) and Carbohydrate (N=30-35). 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 6 and 12 months of intervention and again at 18 months (after 6 months of follow up).

The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention.

The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will loose quadriceps muscle cross sectional areas.

Enrollment: 208 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 4g of ethanol) for men and > 14 for women.
• Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing 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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208 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 20g whey protein and 10g carbohydrate supplementations for 52 weeks.

Treatment:

Dietary Supplement: Protein Whey

Procedure: Heavy Resistance Training

Light Intensity Training

Experimental group

Description:

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

Treatment:

Procedure: Light Intensity Training

Dietary Supplement: Protein Whey

Protein Whey

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Protein Whey

Protein Collagen

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Protein Collagen

Carbohydrate

Placebo Comparator group

Description:

Two daily 30g carbohydrate supplementations for 52 weeks.

Treatment:

Dietary Supplement: Carbohydrate