Multi-ingredient Nutrition Supplement in Older Adults

NCT02001831 | Unknown

• 1 other identifier: SMF-3000
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability

Keywords

Sarcopenia; Frailty; Aging; Skeletal muscle; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Lower extremity physical function

  Change from Baseline at day 84 & day 168

• Cognitive performance

  Change from Baseline at day 84 & day 168

Study Arms (2)

Supplement

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Supplement DIETARY_SUPPLEMENT

Supplement

Placebo DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Smartfish AS: collaborator

Study Sites (1)

UCD Institute for Sport and Health

Dublin, Dublin 4, Ireland

Location

Related Publications (5)

• 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.

  PMID: 8085501 BACKGROUND

• 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.

  PMID: 14769646 BACKGROUND

• 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.

  PMID: 23796946 BACKGROUND

• 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.

  PMID: 8126356 BACKGROUND

• 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.

  PMID: 29972210 DERIVED

MeSH Terms

Conditions

Sarcopenia; Frailty

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Giuseppe De Vito, MD, PhD

  School of Public Health, Physiotherapy and Population Sciences. University College Dublin

  STUDY DIRECTOR

Central Study Contacts

Brendan Egan, PhD

CONTACT

brendan.egan@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Sport and Exercise Science

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: December 5, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2015
• Last Updated: December 5, 2013

Record last verified: 2013-11

Locations

IE (1)