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

Sarcopenia Clinical Trial

— CALM  

Official title:

Counteracting Age-related Loss of Skeletal Muscle Mass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115698
• Other study ID #: H-4-2013-070.3
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: August 2019

Study information

• Verified date: April 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Loss
• Sarcopenia

Intervention

Procedure:
• Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 52 weeks.
• 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.
• Protein Collagen
Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.
• Carbohydrate
Two daily 30 g carbohydrate supplementations for 52 weeks.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Arla Foods, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal overnight fasted muscle protein synthesis rate.	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.	Baseline and 12 months
Primary	Muscle protein synthesis rate response to protein intake from basal overnight fasted state.	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	Baseline and 12 months
Secondary	Muscle protein turnover molecular signaling and gene expression	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.	Baseline and 12 months