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

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ClinicalTrials.gov Identifier: NCT02034760
Recruitment Status : Recruiting
First Posted : January 13, 2014
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
University of Copenhagen
Arla Foods
Information provided by (Responsible Party):
Lars Holm, Bispebjerg Hospital

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Sarcopenia Muscle Loss Procedure: Heavy Resistance Training Procedure: Light Intensity Training Dietary Supplement: Protein Whey Dietary Supplement: Protein Collagen Dietary Supplement: Carbohydrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Counteracting Age-related Loss of Skeletal Muscle Mass
Actual Study Start Date : January 10, 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Active Comparator: Heavy Resistance Training
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.
Procedure: Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 52 weeks.

Dietary Supplement: Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.

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

Dietary Supplement: Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.

Active Comparator: Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Dietary Supplement: Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.

Active Comparator: Protein Collagen
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
Dietary Supplement: Protein Collagen
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.

Placebo Comparator: Carbohydrate
Two daily 30g carbohydrate supplementations for 52 weeks.
Dietary Supplement: Carbohydrate
Two daily 30g carbohydrate supplementations for 52 weeks.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Change in quadriceps muscle isometric strength [ Time Frame: Baseline, 6, 12 and 18 months ]
    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).

  2. Change in quadriceps muscle isokinetic strength [ Time Frame: Baseline, 6, 12 and 18 months ]
    Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.

  3. Change in leg extension muscle power [ Time Frame: Baseline, 6, 12 and 18 months ]
    Unilateral leg extension power measured in the Powerrig device.

  4. Change from baseline in muscle structure and signalling [ Time Frame: Baseline and 12 months ]
    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.

  5. Change in gut microbiota composition. [ Time Frame: Baseline, 6 and 12 months (and 18 months on a subset of samples). ]
    Molecular biology based methods incl. high throughput sequencing aided by classical, culture-based microbiological techniques as needed.

  6. Change in faecal metabolome. [ Time Frame: Baseline, 6 and 12 months (and 18 months on a subset of samples). ]
    NMR of faecal samples.

  7. Change in faecal metabolome. [ Time Frame: Baseline, 6 and 12 months (and 18 months on a subset of samples). ]
    Gas chromatography mass spectrometry (GCMS) of faecal samples.

  8. Change in plasma metabolome. [ Time Frame: Baseline, 6 and 12 months (and 18 months on a subset of samples). ]
    Nuclear magnetic resonance (NMR) of plasma samples.

  9. Change in plasma metabolome. [ Time Frame: Baseline, 6 and 12 months (and 18 months on a subset of samples). ]
    GCMS of plasma samples.

  10. Change in 30 s chair stand [ Time Frame: Baseline, 6, 12 and 18 months ]
    Number of stand-ups from a chair in 30 seconds.

  11. Change in whole body composition and bone mineral density [ Time Frame: Baseline, 6, 12 and 18 months ]

    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.



Other Outcome Measures:
  1. Change in blood parameters and anthropometry [ Time Frame: Baseline, 6, 12 and 18 months ]
    Blood: HbA1c, plasma lipids, vitamin B12 and related metabolites. Anthropometry: Weight, abdominal circumference. Blood pressure.

  2. Change in gait speed [ Time Frame: Baseline, 6, 12 and 18 months ]
    400 m gait speed.

  3. Change in grip strength [ Time Frame: Baseline, 6, 12 and 18 months ]
    Isometric hand grip strength.

  4. Change in tendon biomechanical properties [ Time Frame: Baseline and 12 months ]
    Measurements of tendon biomechanical properties.

  5. Questionnaires and interviews [ Time Frame: Baseline and 12 months ]
    Short Form 36, Pittsburgh Sleep Scale Questionnaire, questionnaires on lifestyle, life history, supplement palatability and interviews and observations of subjects with focus on changes in lifestyle as result of intervention.

  6. Change in daily macronutrient intake [ Time Frame: Baseline, 1.5/2 and 12 months ]
    3-days self-report of food and beverage intake.

  7. Change in habitual activity [ Time Frame: Baseline, 6, 12 and 18 months ]
    Evaluated by 4 days continuous monitoring by a pedometer device (ActivPal).

  8. Questionnaire on acceptance of supplements [ Time Frame: Weekly for first 3 months and every 3rd month until 12 months ]
    Questionnaires on acceptance of supplementation

  9. Change in glucose handling measured by a OGTT [ Time Frame: Baseline and 12 months ]
    Completion of an oral glucose tolerance test (OGTT)

  10. Change in vitamin B12 and related metabolite concentrations in blood [ Time Frame: Baseline, 6, 12 and 18 months ]
    Concentration of total B12, B12 available for cells (holoTC), and methylmalonate (MMA).



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034760


Contacts
Contact: Jacob L. Bülow, MD +45 38 35366 jacob.bulow@live.dk
Contact: Søren Reitelseder, Ph.D. +45 38 35366 s.reitelseder@gmail.com

Locations
Denmark
Bispbebjerg Hospital Recruiting
Copenhagen NV, Denmark, 2400
Contact: Jacob Bülow, MD, Ph.d.stu    +45 38 35366    jacob.bulow@live.dk   
Contact: Søren Reitelseder, M.Sc, Ph.d.    +45 38 35366    s.reitelseder@gmail.com   
Principal Investigator: Jacob Bülow, MD, Ph.d.stu         
Sub-Investigator: Lars Holm, M.Sc., Ph.d.         
Sub-Investigator: Søren Reitelseder, M.Sc., Ph.d.         
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
Arla Foods
Investigators
Principal Investigator: Rasmus Bechshøft, Ph.d. stud Bispebjerg Hospital
Principal Investigator: Lars Holm, Assoc. prof. Bispebjerg Hospital
Principal Investigator: Michael Kjaer, MD, Proff. Bispebjerg Hospital
Principal Investigator: Søren Reitelseder, Ph.d. Bispebjerg Hospital
Principal Investigator: Jacob Bülow, MD PhD stud Bispebjerg Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Holm, Ph.D. M.S., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02034760     History of Changes
Other Study ID Numbers: H-4-2013-070
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

Keywords provided by Lars Holm, Bispebjerg Hospital:
Frailty
Ageing
Protein supplementation
Protein quality
Gut microbiota
Metabolome
Exercise training
Sarcopenia

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms