- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02115698
Counteracting Age-related Loss of Skeletal Muscle Mass (CALM) (CALM)
Counteracting Age-related Loss of Skeletal Muscle Mass
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Copenhagen NV, Denmark, 2400
- Bispebjerg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Heavy Resistance Training
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.
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Supervised Heavy Resistance Training three times weekly for 52 weeks.
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
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Experimental: Light Intensity Training
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.
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Home-based Light Intensity Training three-five times weekly for 52 weeks.
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
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Active Comparator: Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
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Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
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Active Comparator: Protein Collagen
Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.
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Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.
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Placebo Comparator: Carbohydrate
Two daily 30 g carbohydrate supplementations for 52 weeks.
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Two daily 30 g carbohydrate supplementations for 52 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Basal overnight fasted muscle protein synthesis rate.
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Muscle protein synthesis rate response to protein intake from basal overnight fasted state.
Time Frame: Baseline and 12 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein turnover molecular signaling and gene expression
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Kjaer, MD, prof., Bispebjerg Hospital
- Principal Investigator: Rasmus L. Bechshoeft, MD, Bispebjerg Hospital
- Principal Investigator: Søren Reitelseder, PhD, Bispebjerg Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-4-2013-070.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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