Counteracting Age-related Loss of Skeletal Muscle Mass
- Conditions
- SarcopeniaMuscle Loss
- Interventions
- Dietary Supplement: Protein WheyDietary Supplement: Protein CollagenProcedure: Heavy Resistance TrainingDietary Supplement: CarbohydrateProcedure: Light Intensity Training
- Registration Number
- NCT02034760
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- Healthy, independently living
- Age at least 65 years
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protein Whey Protein Whey Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks. Protein Collagen Protein Collagen Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks. Heavy Resistance Training 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. Carbohydrate Carbohydrate Two daily 30g carbohydrate supplementations for 52 weeks. Light Intensity Training 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. Heavy Resistance Training Protein Whey 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. Light Intensity Training Protein Whey 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.
- Primary Outcome Measures
Name Time Method Change in muscle cross sectional area 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
Name Time Method Change in quadriceps muscle isometric strength 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).
Change in quadriceps muscle isokinetic strength Baseline, 6, 12 and 18 months Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec.
Change in leg extension muscle power Baseline, 6, 12 and 18 months Unilateral leg extension power measured in the Powerrig device.
Change in gut microbiota composition. 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.
Change from baseline in muscle structure and signalling 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.
Change in faecal metabolome. Baseline, 6 and 12 months (and 18 months on a subset of samples). Gas chromatography mass spectrometry (GCMS) of faecal samples.
Change in plasma metabolome. Baseline, 6 and 12 months (and 18 months on a subset of samples). GCMS of plasma samples.
Change in 30 s chair stand Baseline, 6, 12 and 18 months Number of stand-ups from a chair in 30 seconds.
Change in whole body composition and bone mineral density 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.
Trial Locations
- Locations (1)
Bispbebjerg Hospital
🇩🇰Copenhagen NV, Denmark