Multi-ingredient Nutrition Supplement in Older Adults

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ClinicalTrials.gov Identifier: NCT02001831

Recruitment Status : Unknown

Verified November 2013 by Brendan Egan, University College Dublin.
Recruitment status was: Not yet recruiting

First Posted : December 5, 2013

Last Update Posted : December 5, 2013

Sponsor:

Collaborator:

Smartfish AS

Information provided by (Responsible Party):

Brendan Egan, University College Dublin

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Physical Disability	Dietary Supplement: Supplement Dietary Supplement: Placebo	Not Applicable

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Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	Effect of a Nutrition Supplement Containing Fish Oil, Whey Protein, Vitamin D, and Resveratrol, on Muscular and Cognitive Function in Older Adults
Study Start Date :	January 2014
Estimated Primary Completion Date :	August 2014
Estimated Study Completion Date :	January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Supplements

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Dietary Supplement: Supplement
Placebo Comparator: 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).	Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures :

Total and appendicular muscle mass [ Time Frame: Change from Baseline at day 84 & day 168 ]
By means of measurement of lean body mass using dual-energy X-ray absorptiometry (DXA)

Secondary Outcome Measures :

Lower extremity physical function [ Time Frame: Change from Baseline at day 84 & day 168 ]
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)
Cognitive performance [ Time Frame: Change from Baseline at day 84 & day 168 ]
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

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

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): NCT02001831

Contacts


Contact: Brendan Egan, PhD		brendan.egan@ucd.ie

Locations


Ireland
UCD Institute for Sport and Health	Active, not recruiting
Dublin, Ireland, Dublin 4

Sponsors and Collaborators

University College Dublin

Smartfish AS

Investigators


Study Director:	Giuseppe De Vito, MD, PhD	School of Public Health, Physiotherapy and Population Sciences. University College Dublin

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Brendan Egan, Lecturer in Sport and Exercise Science, University College Dublin
ClinicalTrials.gov Identifier:	NCT02001831 History of Changes
Other Study ID Numbers:	SMF-3000
First Posted:	December 5, 2013 Key Record Dates
Last Update Posted:	December 5, 2013
Last Verified:	November 2013

Keywords provided by Brendan Egan, University College Dublin:


Sarcopenia Frailty Aging Skeletal muscle Nutrition

Additional relevant MeSH terms:


Vitamins Vitamin D Resveratrol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents	Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Antimutagenic Agents Anticarcinogenic Agents

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