Counteracting Age-related Loss of Skeletal Muscle Mass
NCT02034760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208
Last updated 2019-11-29
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.
Conditions
- Sarcopenia
- Muscle Loss
Interventions
- PROCEDURE
-
Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly 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.
- DIETARY_SUPPLEMENT
-
Protein Collagen
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
- DIETARY_SUPPLEMENT
-
Carbohydrate
Two daily 30g carbohydrate supplementations for 52 weeks.
Sponsors & Collaborators
-
University of Copenhagen
collaborator OTHER -
Arla Foods
collaborator INDUSTRY -
Bispebjerg Hospital
lead OTHER
Principal Investigators
-
Rasmus Bechshøft, Ph.d. stud · Bispebjerg Hospital
-
Lars Holm, Assoc. prof. · Bispebjerg Hospital
-
Michael Kjaer, MD, Proff. · Bispebjerg Hospital
-
Søren Reitelseder, Ph.d. · Bispebjerg Hospital
-
Jacob Bülow, MD PhD stud · Bispebjerg Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-01-10
- Primary Completion
- 2019-06-30
- Completion
- 2019-08-31
Countries
- Denmark
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