NCT02529124

Brief Summary

The focus is healthy ageing, i.e. delaying the deterioration in health status in older adults. Loss of lean tissue (skeletal muscle) mass, a process termed sarcopenia, or bone tissue mass, a process called osteopenia, is a consequence of aging per se, modified by nutrition and lifestyle behaviour. The aim is to conduct a study of body composition, physical activity, muscle function and ability to undertake activities of daily living in older Irish men and women and to investigate the effect of a six month period of nutrient support, or nutrient plus physical activity on lean tissue mass and function and bone mass in men and women aged 50 to 70 years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

4.3 years

First QC Date

August 12, 2015

Last Update Submit

June 24, 2016

Conditions

SarcopeniaOsteopenia

Keywords

AgeingBody CompositionNutritionPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Body Lean Tissue Mass (LTM)

    Body lean tissue mass measured by dual energy x-ray absorptiometry

    Change from baseline in Lean Tissue Mass at 6 months

Secondary Outcomes (1)

  • Bone Mineral Density

    Change from baseline in Bone Mineral Density at 6 months

Other Outcomes (4)

  • Maximal voluntary contraction (MVC) and rate of force development (RFD) of the knee extensors [Muscle Function]

    Change from baseline in Muscle Function at 6 months

  • Rate of force development (RFD) of the knee extensors [Muscle Function]

    Change from baseline in Muscle Function at 6 months

  • Chair Rise Test [Activities of Daily Living]

    Change from baseline in Activities of Daily Living at 6 months

  • +1 more other outcomes

Study Arms (3)

CONTROL

PLACEBO COMPARATOR

a group of subjects receiving a placebo nutrient supplement (per kg of body mass: 0.25g maltodextrin; energy \~ 160 kcal per day) in two equal portions at the two low protein meals of the day, i.e. breakfast and lunch every day for a period of 24 weeks

Dietary Supplement: CONTROL

PROTEIN

ACTIVE COMPARATOR

a group of subjects receiving a nutrient supplement (per kg of body mass: 0.33g milk protein + 0.25ug vitamin D + 10mg calcium; energy \~ 160 kcal per day) in two equal portions at the two low protein meals of the day, i.e. breakfast and lunch every day for a period of 24 weeks

Dietary Supplement: PROTEIN

PROTEIN+PHYSICAL ACTIVITY

ACTIVE COMPARATOR

a group of subjects receiving a nutrient supplement (per kg of body mass: 0.33g milk protein + 0.25ug vitamin D + 10mg calcium; energy \~ 160 kcal per day) in two equal portions at the two low protein meals of the day, i.e. breakfast and lunch every day for a period of 24 weeks plus a prescribed regimen of physical activity

Dietary Supplement: PROTEINBehavioral: PHYSICAL ACTIVITY

Interventions

CONTROLDIETARY_SUPPLEMENT

Maltodextrin (generic) in powder form, flavoured and instantised to be dissolved in water.

Also known as: MALTODEXTRIN
CONTROL
PROTEINDIETARY_SUPPLEMENT

The milk protein matrix (PROTEIN) comprised a 9:2:1 ratio of milk protein concentrate (MPC, 80% (w/w protein) Glanbia Nutritionals, Kilkenny, Ireland), whey protein concentrate hydrolysate, degree of hydrolysis 32% (WPC DH 32, 78% (w/w protein) Carbery Ingredients, Ballineen, Ireland), whey protein isolate hydrolysate, degree of hydrolysis 45% (WPI DH 45, 75% (w/w protein) Glanbia Nutritionals). The total protein content was 72.7g/100g powder. The protein matrix was supplemented with 2187mg/100g powder of milk-based calcium (Trucalâ„¢, Glanbia) and 57.3mg/100g powder vitamin D3 (cholecalciferol), flavoured and instantised to be dissolved in water.

Also known as: MILK PROTEIN MATRIX (MPM)
PROTEINPROTEIN+PHYSICAL ACTIVITY
PHYSICAL ACTIVITYBEHAVIORAL

A structured, progressive programme of exercises using resistance exercise bands supervised by clinical therapists undertaken three times per week for 24 weeks of the intervention.

Also known as: PA
PROTEIN+PHYSICAL ACTIVITY

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conducted by a medical doctor and based on Grieg et al. Age and Aging 1994:23:185-189 being defined as 'healthy' (i.e. 'disease-free') free-living and fully mobile older subjects capable of completing the 6-month intervention

You may not qualify if:

  • Contraindication identified by medical doctor based on Grieg et al. Age and Aging 1994:23:185-189 definition of 'healthy' (i.e. 'disease-free') free-living and fully mobile older subjects capable of completing the 6-month intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Francis P, Mc Cormack W, Toomey C, Norton C, Saunders J, Kerin E, Lyons M, Jakeman P. Twelve weeks' progressive resistance training combined with protein supplementation beyond habitual intakes increases upper leg lean tissue mass, muscle strength and extended gait speed in healthy older women. Biogerontology. 2017 Dec;18(6):881-891. doi: 10.1007/s10522-016-9671-7. Epub 2016 Dec 8.

    PMID: 27933408DERIVED

  • Norton C, Toomey C, McCormack WG, Francis P, Saunders J, Kerin E, Jakeman P. Protein Supplementation at Breakfast and Lunch for 24 Weeks beyond Habitual Intakes Increases Whole-Body Lean Tissue Mass in Healthy Older Adults. J Nutr. 2016 Jan;146(1):65-9. doi: 10.3945/jn.115.219022. Epub 2015 Nov 18.

    PMID: 26581685DERIVED

MeSH Terms

Conditions

SarcopeniaBone Diseases, MetabolicMotor Activity

Interventions

maltodextrinProteinsExercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philip M Jakeman, BSc MSc PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phil Jakeman

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 19, 2015

Study Start

January 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06