Clinical trial NCT02115698: Counteracting Age-related Loss of Skeletal Muscle Mass (CALM)
Official title: Counteracting Age-related Loss of Skeletal Muscle Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Muscle Loss
Keywords: Sarcopenia
Frailty
Ageing
Protein supplementation
Protein quality
Exercise training
Muscle protein turnover
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Arla Foods
First posted: 2014-04-16
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Basal overnight fasted muscle protein synthesis rate.
timeFrame: Baseline and 12 months
measure: Muscle protein synthesis rate response to protein intake from basal overnight fasted state.
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Muscle protein turnover molecular signaling and gene expression
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Rasmus L. Bechshoeft, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Lars Holm, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Michael Kjaer, MD, prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Søren Reitelseder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Jacob Bülow, MD PhD stud
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bechshoft RL, Reitelseder S, Hojfeldt G, Castro-Mejia JL, Khakimov B, Ahmad HF, Kjaer M, Engelsen SB, Johansen SM, Rasmussen MA, Lassen AJ, Jensen T, Beyer N, Serena A, Perez-Cueto FJ, Nielsen DS, Jespersen AP, Holm L. Counteracting Age-related Loss of Skeletal Muscle Mass: a clinical and ethnological trial on the role of protein supplementation and training load (CALM Intervention Study): study protocol for a randomized controlled trial. Trials. 2016 Aug 9;17(1):397. doi: 10.1186/s13063-016-1512-0.