Multi-ingredient Nutrition Supplement in Older Adults

Physical Disability Clinical Trial

Official title:

Effect of a Nutrition Supplement Containing Fish Oil, Whey Protein, Vitamin D, and Resveratrol, on Muscular and Cognitive Function in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02001831
• Other study ID #: SMF-3000
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2013
• Last updated: November 28, 2013
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2013
• Source: University College Dublin
• Contact: Brendan Egan, PhD
• Email: brendan.egan[@]ucd.ie
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aims of the present study are:

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.

Description:

The study is a population study and 6 month randomised control trial (RCT) of men and women aged 70 to 80. The supplement and placebo will be provided in the form of a small 200 mL sealed TetraPak carton and is presented in a highly-palatable, juice-based (pomegranate and apple) formulation. The study groups (n=25 per group) for the RCT are:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• = 70 years of age

• 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:

• Not medically stable by Greig criteria, and the medical history details in the ethics form

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Disability

Intervention

Dietary Supplement:
• Supplement

• Placebo

Locations

Country	Name	City	State
Ireland	UCD Institute for Sport and Health	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	Smartfish AS

Country where clinical trial is conducted

Ireland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Witte AV, Kerti L, Hermannstädter HM, Fiebach JB, Schreiber SJ, Schuchardt JP, Hahn A, Flöel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and appendicular muscle mass	By means of measurement of lean body mass using dual-energy X-ray absorptiometry (DXA)	Change from Baseline at day 84 & day 168	No
Secondary	Lower extremity physical function	By means of score ranging from 0 (worst performance) to 12 (best performance) achieved on the Short Performance Battery Test (Guralnik et al J Gerontol. 1994 49(2):M85-94)	Change from Baseline at day 84 & day 168	No
Secondary	Cognitive performance	By means of performances in the following battery: 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, and Cognitive Failures Questionnaire	Change from Baseline at day 84 & day 168	No