Nutrient Support to Body Composition and Healthy Ageing

NCT ID: NCT02529124

Last Updated: 2016-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Sarcopenia; Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

CONTROL

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: ACTIVE_COMPARATOR

PROTEIN

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

PROTEIN

Intervention Type: 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.

PHYSICAL ACTIVITY

Intervention Type: 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.

Interventions

CONTROL

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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MALTODEXTRIN; MILK PROTEIN MATRIX (MPM); PA

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Phil Jakeman

OTHER

Sponsor Role: lead

Responsible Party

Phil Jakeman

Phil Jakeman

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philip M Jakeman, BSc MSc PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

References

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.

Reference Type: DERIVED

PMID: 27933408 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26581685 (View on PubMed)

Other Identifiers

EHSREC10_45

Identifier Type: -

Identifier Source: org_study_id