Counteracting Age-related Loss of Skeletal Muscle Mass

NCT02034760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2019-11-29

No results posted yet for this study

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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034760 on ClinicalTrials.gov