NCT01997320

Brief Summary

Three months intervention study, investigating the effect of nutrient supplementation (including 20g of milk protein) twice daily with or without additional heavy resistance exercise three times weekly on muscle size, structure and function in 30 subjects at least 83 years of age. Primary hypothesis is that the group conducting exercise improves muscle size, structure and function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

November 11, 2013

Last Update Submit

October 9, 2015

Conditions

Ageing

Keywords

SarcopeniaFrailtyStrengthProtein supplementationAgeing

Outcome Measures

Primary Outcomes (1)

  • Change in quadriceps muscle cross sectional area from baseline to 3 months

    Assessed by MRI scanning of dominant thigh. 8 slices, each of 1cm thickness, separated by 5cm.

    0 and 3 months

Secondary Outcomes (3)

  • Change in isometric muscle strength from baseline to 3 months

    0 and 3 months

  • Change in isokinetic muscle strength from baseline to 3 months

    0 and 3 months

  • Change in leg power from baseline to 3 months

    0 and 3 months

Other Outcomes (7)

  • Change in gait speed from baseline to 3 months

    0 and 3 months

  • Change in DEMMI from baseline to 3 months

    0 and 3 months

  • Change in 30s chair-stand from baseline to 3 months

    0 and 3 months

  • +4 more other outcomes

Study Arms (2)

Heavy resistance exercise and nutrition

EXPERIMENTAL

Heavy resistance exercise of the lower extremities three times weekly for 12 weeks combined with nutrient supplementation twice daily each containing 20g of milk protein.

Other: Heavy resistance exercise and nutrition

Nutrition supplement

ACTIVE COMPARATOR

Nutrient supplementation twice daily for 12 weeks. Each supplement contains 20g of milk protein.

Other: Nutrition supplement

Interventions

Heavy resistance exercise and nutritionOTHER

Heavy resistance exercise of the lower extremities three times weekly for 12 weeks.

Heavy resistance exercise and nutrition
Nutrition supplementOTHER

Two daily administrations of nutrient supplementation, each containing 20g of milk protein.

Nutrition supplement

Eligibility Criteria

Age83 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age at least 83 years

You may not qualify if:

  • Acute severe medical or surgical illnesses.
  • Unstable chronic diseases, eg. renal failure, uncontrolled cardiac arrythmias, severe COPD (Chronic Obstructive Pulmonary Disease), diabetes mellitus.
  • Bilateral knee alloplastics
  • Metal devices compromising MR-scanning.
  • Medicine: Anticoagulants (K-vitamin antagonists, heparins, ADP-receptor blockers, direct thrombin inhibitors, factor Xa inhibitors), systemic steroid treatment.
  • Dementia
  • Regular heavy load resistance exercise more than 20 min/week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen, Bispbebjerg Hospital

Copenhagen NV, Denmark, 2400, Denmark

Location

MeSH Terms

Conditions

SarcopeniaFrailty

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Michael Kjaer, MD, Proff.

    Head of department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.d. student

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 28, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

DK(1)