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Multi-ingredient Nutrition Supplement in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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 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


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



Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. 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



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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

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

Locations
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Ireland
UCD Institute for Sport and Health
Dublin, Ireland, Dublin 4
Sponsors and Collaborators
University College Dublin
Smartfish AS
Investigators
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Study Director: Giuseppe De Vito, MD, PhD School of Public Health, Physiotherapy and Population Sciences. University College Dublin

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brendan Egan, Lecturer in Sport and Exercise Science, University College Dublin
ClinicalTrials.gov Identifier: NCT02001831    
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