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

Primary Purpose

Sarcopenia, Muscle Loss

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Heavy Resistance Training

Light Intensity Training

Protein Whey

Protein Collagen

Carbohydrate

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Muscle protein turnover

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

Heavy Resistance Training

Light Intensity Training

Protein Whey

Protein Collagen

Carbohydrate

Arm Description

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.

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.

Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.

Two daily 30 g carbohydrate supplementations for 52 weeks.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02115698

First Posted

April 14, 2014

Last Updated

April 17, 2023

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen, Arla Foods

1. Study Identification

Unique Protocol Identification Number

NCT02115698

Brief Title

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

Acronym

CALM

Official Title

Counteracting Age-related Loss of Skeletal Muscle Mass

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2014 (Actual)

Primary Completion Date

June 2019 (Actual)

Study Completion Date

August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen, Arla Foods

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, Muscle Loss

Keywords

Sarcopenia, Frailty, Ageing, Protein supplementation, Protein quality, Exercise training, Muscle protein turnover

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heavy Resistance Training

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Light Intensity Training

Arm Type

Experimental

Arm Description

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.

Arm Title

Protein Whey

Arm Type

Active Comparator

Arm Description

Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Arm Title

Protein Collagen

Arm Type

Active Comparator

Arm Description

Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.

Arm Title

Carbohydrate

Arm Type

Placebo Comparator

Arm Description

Two daily 30 g carbohydrate supplementations for 52 weeks.

Intervention Type

Procedure

Intervention Name(s)

Heavy Resistance Training

Intervention Description

Supervised Heavy Resistance Training three times weekly for 52 weeks.

Intervention Type

Procedure

Intervention Name(s)

Light Intensity Training

Intervention Description

Home-based Light Intensity Training three-five times weekly for 52 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Protein Whey

Intervention Description

Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Protein Collagen

Intervention Description

Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Carbohydrate

Intervention Description

Two daily 30 g carbohydrate supplementations for 52 weeks.

Primary Outcome Measure Information:

Title

Basal overnight fasted muscle protein synthesis rate.

Description

Time Frame

Baseline and 12 months

Title

Muscle protein synthesis rate response to protein intake from basal overnight fasted state.

Description

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

Muscle protein turnover molecular signaling and gene expression

Description

Time Frame

Baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: