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Nutrient Support to Body Composition and Healthy Ageing (BCHA)

Primary Purpose

Sarcopenia, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CONTROL
PROTEIN
PHYSICAL ACTIVITY
Sponsored by
Phil Jakeman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Ageing, Body Composition, Nutrition, Physical Activity

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    CONTROL

    PROTEIN

    PROTEIN+PHYSICAL ACTIVITY

    Arm Description

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    Body Lean Tissue Mass (LTM)
    Body lean tissue mass measured by dual energy x-ray absorptiometry

    Secondary Outcome Measures

    Bone Mineral Density
    Site specific (Lumbar Spine and Femoral Neck) bone mineral density measured by dual energy x-ray absorptiometry

    Full Information

    First Posted
    August 12, 2015
    Last Updated
    June 24, 2016
    Sponsor
    Phil Jakeman
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02529124
    Brief Title
    Nutrient Support to Body Composition and Healthy Ageing
    Acronym
    BCHA
    Official Title
    An Investigation of the the Effect of Nutrient Support, or Nutrient Plus Physical Activity on Musculoskeletal Health and Function in Men and Women Aged 55 to 70 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Phil Jakeman

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Study Design: The study is a convenience population study and 6-month randomised control trial (RCT) of men and women age 55 to 70 years. The study groups (n=60 per group) for the RCT are: CON - a control group receiving a placebo nutrient support (per kg of body mass: 0.25g maltodextrin; energy ~ 160 kcal per day) PRO - a nutrient group receiving a nutrient support (per kg of body mass: 0.33g milk protein + 0.25ug vitamin D + 10mg calcium; energy ~ 160 kcal per day) PRO+PA - a nutrient group receiving a nutrient support (per kg of body mass: 0.33g milk protein + 0.25ug vitamin D + 10mg calcium; energy ~ 160 kcal per day) and engaging in a prescribed physical activity (PA). Subject recruitment: Men and women, age 50 to 70 years, will be recruited through the UL Body Composition Study, by email advertisement, GP-exercise referral scheme, feature article(s) in the local media and word of mouth. Requirement of the participants. On entry each subject will undertake a preliminary assessment as follows: i. medical history and examination by a qualified medical doctor ; ii. provide a blood and urine sample to be evaluated by a qualified medical doctor; iii. food intake evaluated by a qualified dietician; iv. whole body and segmental body composition analysis (DXA); v. habitual physical activity level (PAL) vi. measurement of muscle function and performance in simulated activities of daily living. One month following the preliminary assessment subjects will be invited to participate in a 6 month intervention programme of nutrient or nutrient plus physical activity. Consenting subjects will be randomly assigned to one of the three study groups stated above. Upon completion (6 months), subjects will be re-assessed as follows; i. provide a blood and urine sample; ii. whole body and segmental body composition analysis (DXA); iii. measurement of muscle function and performance in simulated activities of daily living.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia, Osteopenia
    Keywords
    Ageing, Body Composition, Nutrition, Physical Activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    254 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CONTROL
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    PROTEIN
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    PROTEIN+PHYSICAL ACTIVITY
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    CONTROL
    Other Intervention Name(s)
    MALTODEXTRIN
    Intervention Description
    Maltodextrin (generic) in powder form, flavoured and instantised to be dissolved in water.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PROTEIN
    Other Intervention Name(s)
    MILK PROTEIN MATRIX (MPM)
    Intervention Description
    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 (Trucal™, Glanbia) and 57.3mg/100g powder vitamin D3 (cholecalciferol), flavoured and instantised to be dissolved in water.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PHYSICAL ACTIVITY
    Other Intervention Name(s)
    PA
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body Lean Tissue Mass (LTM)
    Description
    Body lean tissue mass measured by dual energy x-ray absorptiometry
    Time Frame
    Change from baseline in Lean Tissue Mass at 6 months
    Secondary Outcome Measure Information:
    Title
    Bone Mineral Density
    Description
    Site specific (Lumbar Spine and Femoral Neck) bone mineral density measured by dual energy x-ray absorptiometry
    Time Frame
    Change from baseline in Bone Mineral Density at 6 months
    Other Pre-specified Outcome Measures:
    Title
    Maximal voluntary contraction (MVC) and rate of force development (RFD) of the knee extensors [Muscle Function]
    Description
    Maximal voluntary contraction (MVC) in Nm (force in Newtons, distance in metres) torque of the knee extensors measured by ergometry will be used to assess Muscle Function.
    Time Frame
    Change from baseline in Muscle Function at 6 months
    Title
    Rate of force development (RFD) of the knee extensors [Muscle Function]
    Description
    Rate of force development (RFD) in Nm/s (force in Newtons, distance in metres, time in seconds) torque of the knee extensors measured by ergometry will be used to assess Muscle Function.
    Time Frame
    Change from baseline in Muscle Function at 6 months
    Title
    Chair Rise Test [Activities of Daily Living]
    Description
    The number of completed Chair Rise (i.e. rise from a seated to a standing position) in 30 seconds will be used to assess Activities of Daily Living
    Time Frame
    Change from baseline in Activities of Daily Living at 6 months
    Title
    Timed 1000m walk [Activities of Daily Living]
    Description
    The time (time in seconds) to complete 1000 metres (distance in metres) performed in a indoor track will be used to assess Activities of Daily Living
    Time Frame
    Change from baseline in Activities of Daily Living at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philip M Jakeman, BSc MSc PhD
    Organizational Affiliation
    University of Limerick
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27933408
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26581685
    Citation
    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.
    Results Reference
    derived

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    Nutrient Support to Body Composition and Healthy Ageing

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