SarcopeniaCALMNCT02034760
Counteracting Age-related Loss of Skeletal Muscle Mass
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 approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects. 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
- 208 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 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 4g of ethanol) for men and > 14 for women.
- Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing 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
Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects.
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=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50), Protein Collagen (N=40-50) and Carbohydrate (N=30-35). 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 6 and 12 months of intervention and again at 18 months (after 6 months of follow up).
The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention.
The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will loose quadriceps muscle cross sectional areas.
- Conditions
- Sarcopenia, Muscle Loss
- Being tested
- Heavy Resistance Training, Light Intensity Training, Protein Whey, Protein Collagen, Carbohydrate
- Keywords
- Frailty, Ageing, Protein supplementation, Protein quality, Gut microbiota, Metabolome, Exercise training, Sarcopenia
- 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 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Protein CollagenDietary supplement
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
CarbohydrateDietary supplement
Two daily 30g 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 20g whey protein and 10g 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 20g whey protein and 10g carbohydrate supplementations for 52 weeks. Receives: Procedure: Light Intensity Training; Dietary Supplement: Protein Whey |
| Protein Whey | Active comparator | Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks. Receives: Dietary Supplement: Protein Whey |
| Protein Collagen | Active comparator | Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks. Receives: Dietary Supplement: Protein Collagen |
| Carbohydrate | Placebo comparator | Two daily 30g 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.
Change in muscle cross sectional area
MRi scans of quadriceps muscle cross sectional area. The primary time interval for assessment of the primary outcome measure is from Baseline to 12 months intervention. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey and 2) Protein Whey vs. Protein Collagen vs. Carbohydrate. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis.
Assessments are performed at 6 months as well and at 18 months (after 6 months follow up). Changes in muscle cross sectional area will be evaluated over 6 months from Baseline to 6 months, from 6 to 12 months, and from 12 months to 18 months.
Measured: Baseline, 6, 12, and 18 months
Secondary outcomes (11)
Change in quadriceps muscle isometric strength
Isometric unilateral quadriceps force and rate of force development measured in the isokinetic dynamometer device (KinCom) during knee extension at the knee angle 70 deg (with 0 degrees being fully extended).
Measured: Baseline, 6, 12 and 18 months
Change in quadriceps muscle isokinetic strength
Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.
Measured: Baseline, 6, 12 and 18 months
Change in leg extension muscle power
Unilateral leg extension power measured in the Powerrig device.
Measured: Baseline, 6, 12 and 18 months
Change from baseline in muscle structure and signalling
From muscle biopsies muscle fiber type distribution and size, capillary density, satellite cell count and activity, selected gene-expression targets and protein concentrations will be assessed.
Measured: Baseline and 12 months
Change in gut microbiota composition.
Molecular biology based methods incl. high throughput sequencing aided by classical, culture-based microbiological techniques as needed.
Measured: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in faecal metabolome.
NMR of faecal samples.
Measured: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in faecal metabolome.
Gas chromatography mass spectrometry (GCMS) of faecal samples.
Measured: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in plasma metabolome.
Nuclear magnetic resonance (NMR) of plasma samples.
Measured: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in plasma metabolome.
GCMS of plasma samples.
Measured: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in 30 s chair stand
Number of stand-ups from a chair in 30 seconds.
Measured: Baseline, 6, 12 and 18 months
Change in whole body composition and bone mineral density
Body composition (fat mass, lean mass and bone mass) evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning.
Bone mineral density at vertebrae L2-L4 and collum femoris evaluated by DXA-scanning.
Measured: Baseline, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start10 Jan 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 (3)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
- 208 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 Bechshøft, Ph.d. stud, Principal investigator, Bispebjerg HospitalLars Holm, Assoc. prof., Principal investigator, Bispebjerg HospitalMichael Kjaer, MD, Proff., Principal investigator, Bispebjerg HospitalSøren Reitelseder, Ph.d., Principal investigator, Bispebjerg HospitalJacob Bülow, MD PhD stud, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034760
- Sponsor's protocol ID
- H-4-2013-070
- Acronym
- CALM
- Status last verified
- Nov 2019
- First submitted
- 10 Jan 2014
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mertz KH, Reitelseder S, Rasmussen MA, Bulow J, Hojfeldt G, Jensen M, Hjulmand M, Lindberg J, Kramer MU, Bechshoft R, Holm L. Changes in Muscle Mass and Strength During Follow-Up After One-Year Resistance Training Interventions in Older Adults. J Strength Cond Res. 2023 Oct 1;37(10):2064-2070. doi: 10.1519/JSC.0000000000004517. Epub 2023 Jul 17.
PubMed 37463344Mertz KH, Reitelseder S, Bechshoeft R, Bulow J, Hojfeldt G, Jensen M, Schacht SR, Lind MV, Rasmussen MA, Mikkelsen UR, Tetens I, Engelsen SB, Nielsen DS, Jespersen AP, Holm L. The effect of daily protein supplementation, with or without resistance training for 1 year, on muscle size, strength, and function in healthy older adults: A randomized controlled trial. Am J Clin Nutr. 2021 Apr 6;113(4):790-800. doi: 10.1093/ajcn/nqaa372.
PubMed 33564844Bechshoft 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 29 Nov 2019. 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
- NCT02034760
- Acronym / sponsor ID
- CALM / H-4-2013-070
- Conditions
- Sarcopenia, Muscle Loss
- Keywords
- Frailty, Ageing, Protein supplementation, Protein quality, Gut microbiota, Metabolome, Exercise training, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Arla Foods
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 13 Jan 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 approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects.
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=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50), Protein Collagen (N=40-50) and Carbohydrate (N=30-35). 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 6 and 12 months of intervention and again at 18 months (after 6 months of follow up).
The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention.
The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will loose quadriceps muscle cross sectional areas.
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 20g whey protein and 10g 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 20g whey protein and 10g carbohydrate supplementations for 52 weeks. |
| Protein Whey | Active comparator | Dietary Supplement: Protein WheyTwo daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks. |
| Protein Collagen | Active comparator | Dietary Supplement: Protein CollagenTwo daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks. |
| Carbohydrate | Placebo comparator | Dietary Supplement: CarbohydrateTwo daily 30g 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 4g 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 20g whey protein and 10g carbohydrate supplementations for 52 weeks. | Dietary supplement | Heavy Resistance Training, Light Intensity Training, Protein Whey |
| Protein CollagenTwo daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks. | Dietary supplement | Protein Collagen |
| CarbohydrateTwo daily 30g carbohydrate supplementations for 52 weeks. | Dietary supplement | Carbohydrate |
Primary outcome
Change in muscle cross sectional area
Time frame: Baseline, 6, 12, and 18 months
MRi scans of quadriceps muscle cross sectional area. The primary time interval for assessment of the primary outcome measure is from Baseline to 12 months intervention. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey and 2) Protein Whey vs. Protein Collagen vs. Carbohydrate. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis. Assessments are performed at 6 months as well and at 18 months (after 6 months follow up). Changes in muscle cross sectional area will be evaluated over 6 months from Baseline to 6 months, from 6 to 12 months, and from 12 months to 18 months.
11 secondary outcomes
Change in quadriceps muscle isometric strength
Time frame: Baseline, 6, 12 and 18 months
Change in quadriceps muscle isokinetic strength
Time frame: Baseline, 6, 12 and 18 months
Change in leg extension muscle power
Time frame: Baseline, 6, 12 and 18 months
Change from baseline in muscle structure and signalling
Time frame: Baseline and 12 months
Change in gut microbiota composition.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in faecal metabolome.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in faecal metabolome.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in plasma metabolome.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in plasma metabolome.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in 30 s chair stand
Time frame: Baseline, 6, 12 and 18 months
Change in whole body composition and bone mineral density
Time frame: Baseline, 6, 12 and 18 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 29 Nov 2019.
- Derived from this study: PubMed 37463344Mertz KH, Reitelseder S, Rasmussen MA, Bulow J, Hojfeldt G, Jensen M, Hjulmand M, Lindberg J, Kramer MU, Bechshoft R, Holm L. Changes in Muscle Mass and Strength During Follow-Up After One-Year Resistance Training Interventions in Older Adults. J Strength Cond Res. 2023 Oct 1;37(10):2064-2070. doi: 10.1519/JSC.0000000000004517. Epub 2023 Jul 17.
- Derived from this study: PubMed 33564844Mertz KH, Reitelseder S, Bechshoeft R, Bulow J, Hojfeldt G, Jensen M, Schacht SR, Lind MV, Rasmussen MA, Mikkelsen UR, Tetens I, Engelsen SB, Nielsen DS, Jespersen AP, Holm L. The effect of daily protein supplementation, with or without resistance training for 1 year, on muscle size, strength, and function in healthy older adults: A randomized controlled trial. Am J Clin Nutr. 2021 Apr 6;113(4):790-800. doi: 10.1093/ajcn/nqaa372.
- 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 Bechshøft, Ph.d. stud principal investigator
Bispebjerg Hospital
Lars Holm, Assoc. prof. principal investigator
Bispebjerg Hospital
Michael Kjaer, MD, Proff. 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 29 Nov 2019. 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?
Change in muscle cross sectional area (time frame: Baseline, 6, 12, and 18 months). 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 NCT02034760, which also lists 3 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 29 Nov 2019.