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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
208
Supervised Heavy Resistance Training three times weekly for 52 weeks.
Home-based Light Intensity Training three-five times weekly for 52 weeks.
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
Two daily 30g carbohydrate supplementations for 52 weeks.
Bispbebjerg Hospital
Copenhagen NV, Denmark
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.
Time frame: Baseline, 6, 12, and 18 months
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).
Time frame: 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.
Time frame: Baseline, 6, 12 and 18 months
Change in leg extension muscle power
Unilateral leg extension power measured in the Powerrig device.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in faecal metabolome.
NMR of faecal samples.
Time frame: 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.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in plasma metabolome.
Nuclear magnetic resonance (NMR) of plasma samples.
Time frame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
Change in plasma metabolome.
GCMS of plasma samples.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, 12 and 18 months
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