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Completed

NCT Number: NCT02034760

Counteracting Age-related Loss of Skeletal Muscle Mass

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.

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Key information

Conditions

Sarcopenia Atrophy Frailty Muscle Loss Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispbebjerg Hospital

Copenhagen NV, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heavy Resistance Training

Procedure

Supervised Heavy Resistance Training three times weekly for 52 weeks.

Light Intensity Training

Procedure

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

Protein Whey

Dietary Supplement

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

Protein Collagen

Dietary Supplement

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

Carbohydrate

Dietary Supplement

Two daily 30g carbohydrate supplementations for 52 weeks.

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Arla Foods
  • University of Copenhagen

Registry information

Acronym: CALM

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2014
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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