SarcopeniaCALMNCT02115698
Counteracting Age-related Loss of Skeletal Muscle Mass (CALM)
A study testing Heavy Resistance Training, Light Intensity Training and Protein Whey in people with Sarcopenia and Muscle Loss, run by Bispebjerg Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Loss
- What is being tested?
- Heavy Resistance Training, Light Intensity Training and Protein Whey
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2014to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy, independently living
- Age at least 65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Sarcopenia, Muscle Loss
- Being tested
- Heavy Resistance Training, Light Intensity Training, Protein Whey, Protein Collagen, Carbohydrate
- Keywords
- Sarcopenia, Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Muscle protein turnover
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy Resistance TrainingProcedure or surgery
Supervised Heavy Resistance Training three times weekly for 52 weeks.
Light Intensity TrainingProcedure or surgery
Home-based Light Intensity Training three-five times weekly for 52 weeks.
Protein WheyDietary supplement
Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
Protein CollagenDietary supplement
Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.
CarbohydrateDietary supplement
Two daily 30 g carbohydrate supplementations for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Heavy Resistance Training | Active comparator | 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. Receives: Procedure: Heavy Resistance Training; Dietary Supplement: Protein Whey |
| Light Intensity Training | Experimental | 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. Receives: Procedure: Light Intensity Training; Dietary Supplement: Protein Whey |
| Protein Whey | Active comparator | Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. Receives: Dietary Supplement: Protein Whey |
| Protein Collagen | Active comparator | Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks. Receives: Dietary Supplement: Protein Collagen |
| Carbohydrate | Placebo comparator | Two daily 30 g carbohydrate supplementations for 52 weeks. Receives: Dietary Supplement: Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
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
Measured: Baseline and 12 months
Secondary outcomes (1)
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study start1 Apr 2014
- Primary completionJun 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Arla Foods
- Responsible party
- Principal investigator, Lars Holm, Bispebjerg Hospital
- Investigators
- Rasmus L. Bechshoeft, MD, Principal investigator, Bispebjerg HospitalLars Holm, assoc. prof., Principal investigator, Bispebjerg HospitalMichael Kjaer, MD, prof., Principal investigator, Bispebjerg HospitalSøren Reitelseder, PhD, Principal investigator, Bispebjerg HospitalJacob Bülow, MD PhD stud, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115698
- Sponsor's protocol ID
- H-4-2013-070.3
- Acronym
- CALM
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2014
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37266586Bechshoft 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.
PubMed 27507236
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counteracting Age-related Loss of Skeletal Muscle Mass
- ClinicalTrials.gov ID
- NCT02115698
- Acronym / sponsor ID
- CALM / H-4-2013-070.3
- Conditions
- Sarcopenia, Muscle Loss
- Keywords
- Sarcopenia, Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Muscle protein turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Arla Foods
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Heavy Resistance Training | Active comparator | Procedure: Heavy Resistance Training, Dietary Supplement: Protein WheyHeavy 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. |
| Light Intensity Training | Experimental | Procedure: Light Intensity Training, Dietary Supplement: Protein WheyHome-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. |
| Protein Whey | Active comparator | Dietary Supplement: Protein WheyTwo daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. |
| Protein Collagen | Active comparator | Dietary Supplement: Protein CollagenTwo daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks. |
| Carbohydrate | Placebo comparator | Dietary Supplement: CarbohydrateTwo daily 30 g carbohydrate supplementations for 52 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy, independently living
- Age at least 65 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy Resistance TrainingSupervised Heavy Resistance Training three times weekly for 52 weeks. | Procedure or surgery | Heavy Resistance Training |
| Light Intensity TrainingHome-based Light Intensity Training three-five times weekly for 52 weeks. | Procedure or surgery | Light Intensity Training |
| Protein WheyTwo daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. | Dietary supplement | Heavy Resistance Training, Light Intensity Training, Protein Whey |
| Protein CollagenTwo daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks. | Dietary supplement | Protein Collagen |
| CarbohydrateTwo daily 30 g carbohydrate supplementations for 52 weeks. | Dietary supplement | Carbohydrate |
Primary outcome
Basal overnight fasted muscle protein synthesis rate.
Time frame: Baseline and 12 months
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.
Muscle protein synthesis rate response to protein intake from basal overnight fasted state.
Time frame: Baseline and 12 months
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
1 secondary outcome
Muscle protein turnover molecular signaling and gene expression
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 37266586Bulow 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.
- Derived from this study: PubMed 27507236Bechshoft 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasmus L. Bechshoeft, MD principal investigator
Bispebjerg Hospital
Lars Holm, assoc. prof. principal investigator
Bispebjerg Hospital
Michael Kjaer, MD, prof. principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy Resistance Training, Light Intensity Training and Protein Whey in people with Sarcopenia and Muscle Loss, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal overnight fasted muscle protein synthesis rate. (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.