Study Results
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Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-01-31
2015-01-31
Brief Summary
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i. To conduct a population study of body composition, muscle function and ability to undertake activities of daily living in elderly Irish individuals
ii. To investigate the effect of a six month period of nutrition supplement support on lean tissue mass, and muscle and cognitive function in individuals aged 70 to 80 years.
Detailed Description
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Control - a control group receiving a placebo nutrient support (200 mL juice; energy \~ 100 kcal per day)
Supplement - a nutrient group receiving a liquid nutrient support (quantity 200 mL per day; energy 200 kcal per day):
Carbohydrate 28.5 g Protein 8 g as Whey Protein Isolate (i) ω-3 PUFA (ii) 3000 mg, as DHA 1500mg, as EPA 1500mg Vitamin D3 (iii) 10 μg Resveratrol (iv) 150 mg
(i) Whey protein isolate - increasing protein intake in elderly individuals is widely proposed as key preventing the decline in muscle mass with aging, (ii) ω-3/EPA/DHA fatty acids - increasing ω-3 consumption is associated with improvements in inflammatory status, blood lipid profile and cognitive function in various populations (iii) A relative deficiency in vitamin D is widely reported in Western populations, whereas recent reports have suggested vitamin D3 supplementation as efficacious for muscle function, (iv) Resveratrol, a polyphenol derived from grape skin that shows promise as a supplement to improve muscle function, metabolic health, prevent wasting and promote longevity.
Participants will undertake a first preliminary screening, which will take part at the Human Performance Laboratory at the University College Dublin (UCD) Institute for Sport and Health, or, alternatively, in a home-based environment, according to participants preferences, in order to assess inclusion/exclusion criteria.
After having examined the participant information leaflet, participants will provide informed consent in writing, complete the medical history examination, a food intake diary and food frequency questionnaire as well as habitual physical activity level questionnaire (CHAMPS).
Next, they will have their stature, body composition, and functional capacity assessed as described below. If fulfilling the eligibility criteria, subjects will undertake 3 assessment sessions (at baseline, 12 wk \& 24 wk) at the Human Performance Laboratory at the UCD Institute for Sport and Health, consisting of body composition, functional capacity, and cognitive performance assessment.
In detail:
i. Body composition (fat, muscle and bone mass by Dual Energy X-Ray Absorptiometry (DXA) (Expected time \~ 15 min)
ii. Provide a blood sample taken via venepuncture to a superficial antecubital vein to be later analysed to assess lipidemic profile, plasma glucose, insulin, and inflammatory markers (Expected time \~ 5 min)
iii. Measurement of muscle strength and lower extremity muscle function in simulated activities of daily living by hand grip, usual walking speed, chair rise test, sit and reach test, and balance test \[Short Performance Battery Test (Guralnik et al. 1994)\]. (Expected time \~ 40 min)
iv. Assessment of cognitive function by the following battery modeled upon that used in Witte et al. (2013) (Expected time \~ 45 min):
* Timed Up and Go test
* Trail Making Test (TMT) part A and B
* Auditory Verbal Learning Test
* Stroop Colour-Word Test
* Verbal Fluency
* Forward and Backward Digit Spans
* Cognitive Failures Questionnaire
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Supplement
Liquid nutrient support (quantity 200 mL per day; energy 200 kcal per day):
Carbohydrate 28.5 g
Protein 8 g as Whey Protein Isolate
ω-3 PUFA 3000 mg, as DHA 1500mg, as EPA 1500mg
Vitamin D3 10 μg
Resveratrol 150 mg
Supplement
Control
Placebo control
Liquid nutrient support
Quantity 200 mL per day - fruit juice only i,e. in absence of bioactives present in the "supplement" (whey protein, omega 3, vitamin D and resveratrol).
Placebo
Interventions
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Supplement
Placebo
Eligibility Criteria
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Inclusion Criteria
* Medically stable, according to Greig et al. (1994)
* BMI between 20 and 30 kg/m2
* Sedentary lifestyle, defined by ≤125 min/week of activity on the CHAMPS-18 questionnaire;
Exclusion Criteria
* Conducting an active lifestyle
* Skeletal muscle index (SMI) of ≥ 6.75 kg/m2 for women or ≥ 10.75 kg/m2 for men according to Janssen et al. (2003)
* Cognitive impairment expressed as mini mental state examination (MMSE) score ≤ 23.
* Current or recent (8 wk) use of fish-oil supplement intake
* Current or recent (8 wk) use of proteins, vitamins or other supplements interfering the metabolic scope
70 Years
ALL
Yes
Sponsors
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Smartfish AS
INDUSTRY
University College Dublin
OTHER
Responsible Party
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Brendan Egan
Lecturer in Sport and Exercise Science
Principal Investigators
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Giuseppe De Vito, MD, PhD
Role: STUDY_DIRECTOR
School of Public Health, Physiotherapy and Population Sciences. University College Dublin
Locations
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UCD Institute for Sport and Health
Dublin, , Ireland
Countries
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Central Contacts
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References
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Greig CA, Young A, Skelton DA, Pippet E, Butler FM, Mahmud SM. Exercise studies with elderly volunteers. Age Ageing. 1994 May;23(3):185-9. doi: 10.1093/ageing/23.3.185.
Janssen I, Baumgartner RN, Ross R, Rosenberg IH, Roubenoff R. Skeletal muscle cutpoints associated with elevated physical disability risk in older men and women. Am J Epidemiol. 2004 Feb 15;159(4):413-21. doi: 10.1093/aje/kwh058.
Witte AV, Kerti L, Hermannstadter HM, Fiebach JB, Schreiber SJ, Schuchardt JP, Hahn A, Floel A. Long-chain omega-3 fatty acids improve brain function and structure in older adults. Cereb Cortex. 2014 Nov;24(11):3059-68. doi: 10.1093/cercor/bht163. Epub 2013 Jun 24.
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
Moran C, Scotto di Palumbo A, Bramham J, Moran A, Rooney B, De Vito G, Egan B. Effects of a Six-Month Multi-Ingredient Nutrition Supplement Intervention of Omega-3 Polyunsaturated Fatty Acids, vitamin D, Resveratrol, and Whey Protein on Cognitive Function in Older Adults: A Randomised, Double-Blind, Controlled Trial. J Prev Alzheimers Dis. 2018;5(3):175-183. doi: 10.14283/jpad.2018.11.
Other Identifiers
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SMF-3000
Identifier Type: -
Identifier Source: org_study_id