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Nutrient Support to Body Composition and Healthy Ageing (BCHA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02529124
First Posted: August 19, 2015
Last Update Posted: June 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Phil Jakeman, University of Limerick
  Purpose

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.


Condition Intervention
Sarcopenia Osteopenia Dietary Supplement: CONTROL Dietary Supplement: PROTEIN Behavioral: PHYSICAL ACTIVITY

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Phil Jakeman, University of Limerick:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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

  • 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


Enrollment: 254
Study Start Date: January 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CONTROL
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
Maltodextrin (generic) in powder form, flavoured and instantised to be dissolved in water.
Other Name: MALTODEXTRIN
Active Comparator: PROTEIN
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
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 Name: MILK PROTEIN MATRIX (MPM)
Active Comparator: PROTEIN+PHYSICAL ACTIVITY
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: PROTEIN
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 Name: MILK PROTEIN MATRIX (MPM)
Behavioral: PHYSICAL ACTIVITY
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 Name: PA

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:

  1. CON - a control group receiving a placebo nutrient support (per kg of body mass: 0.25g maltodextrin; energy ~ 160 kcal per day)
  2. 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)
  3. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529124


Sponsors and Collaborators
Phil Jakeman
Investigators
Principal Investigator: Philip M Jakeman, BSc MSc PhD University of Limerick
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Phil Jakeman, University of Limerick
ClinicalTrials.gov Identifier: NCT02529124     History of Changes
Other Study ID Numbers: EHSREC10_45
First Submitted: August 12, 2015
First Posted: August 19, 2015
Last Update Posted: June 27, 2016
Last Verified: June 2016

Keywords provided by Phil Jakeman, University of Limerick:
Ageing
Body Composition
Nutrition
Physical Activity

Additional relevant MeSH terms:
Sarcopenia
Bone Diseases, Metabolic
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents