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Completed

NCT Number: NCT02529124

Nutrient Support to Body Composition and Healthy Ageing

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.

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Key information

Conditions

Sarcopenia Atrophy Behavior Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Motor Activity Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteopenia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

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

Other names: MALTODEXTRIN

Protein

Dietary 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 (Trucal™, Glanbia) and 57.3mg/100g powder vitamin D3 (cholecalciferol), flavoured and instantised to be dissolved in water.

Other names: MILK PROTEIN MATRIX (MPM)

Physical activity

Behavioral

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.

Other names: PA

Primary outcomes

  1. Body Lean Tissue Mass (LTM)

    Time frame: Change from baseline in Lean Tissue Mass at 6 months

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

Secondary outcomes

  1. Bone Mineral Density

    Time frame: Change from baseline in Bone Mineral Density at 6 months

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

Other outcomes

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

    Time frame: Change from baseline in Muscle Function at 6 months

    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.

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

    Time frame: Change from baseline in Muscle Function at 6 months

    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.

  3. Chair Rise Test [Activities of Daily Living]

    Time frame: Change from baseline in Activities of Daily Living at 6 months

    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

  4. Timed 1000m walk [Activities of Daily Living]

    Time frame: Change from baseline in Activities of Daily Living at 6 months

    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

Sponsors and collaborators

Lead sponsor

Phil Jakeman

Other

Registry information

Official study 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

Acronym: BCHA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2015
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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