Clinical trial NCT02529124: Nutrient Support to Body Composition and Healthy Ageing
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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Osteopenia
Keywords: Ageing
Body Composition
Nutrition
Physical Activity
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 254
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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:

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 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

Primary outcomes:
measure: Body Lean Tissue Mass (LTM)
timeFrame: Change from baseline in Lean Tissue Mass at 6 months
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: Change from baseline in Bone Mineral Density at 6 months
Other outcomes:
measure: Maximal voluntary contraction (MVC) and rate of force development (RFD) of the knee extensors [Muscle Function]
timeFrame: Change from baseline in Muscle Function at 6 months
measure: Rate of force development (RFD) of the knee extensors [Muscle Function]
timeFrame: Change from baseline in Muscle Function at 6 months
measure: Chair Rise Test [Activities of Daily Living]
timeFrame: Change from baseline in Activities of Daily Living at 6 months
measure: Timed 1000m walk [Activities of Daily Living]
timeFrame: Change from baseline in Activities of Daily Living at 6 months
Locations:
Study officials:
affiliation: University of Limerick
name: Philip M Jakeman, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.