Counteracting Age-related Loss of Skeletal Muscle Mass (CALM)
NCT ID: NCT02115698
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2014-04-01
2019-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 52 weeks.
Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
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.
Light Intensity Training
Home-based Light Intensity Training three-five times weekly for 52 weeks.
Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
Protein Whey
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
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.
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.
Carbohydrate
Two daily 30 g carbohydrate supplementations for 52 weeks.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Age at least 65 years
Exclusion Criteria
* 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
65 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Arla Foods
INDUSTRY
Bispebjerg Hospital
OTHER
Responsible Party
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Lars Holm
PhD, MS
Principal Investigators
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Rasmus L. Bechshoeft, MD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Lars Holm, assoc. prof.
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Michael Kjaer, MD, prof.
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Søren Reitelseder, PhD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Jacob Bülow, MD PhD stud
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
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Bispebjerg Hospital
Copenhagen NV, , Denmark
Countries
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References
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Bulow J, Khakimov B, Reitelseder S, Bechshoft R, Jensen M, van Hall G, Engelsen SB, Holm L. Effect of 1-year daily protein supplementation and physical exercise on muscle protein synthesis rate and muscle metabolome in healthy older Danes: a randomized controlled trial. Eur J Nutr. 2023 Sep;62(6):2673-2685. doi: 10.1007/s00394-023-03182-0. Epub 2023 Jun 2.
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.
Other Identifiers
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H-4-2013-070.3
Identifier Type: -
Identifier Source: org_study_id
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