Trial record 19 of 1690 for:    Open Studies | dietary supplements

Multi-ingredient Nutrition Supplement in Older Adults

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University College Dublin
Sponsor:
Collaborator:
Smartfish AS
Information provided by (Responsible Party):
Brendan Egan, University College Dublin
ClinicalTrials.gov Identifier:
NCT02001831
First received: August 15, 2013
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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 Intervention
Physical Disability
Dietary Supplement: Supplement
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Total and appendicular muscle mass [ Time Frame: Change from Baseline at day 84 & day 168 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: August 15, 2013
Last Updated: November 28, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Dublin:
Sarcopenia
Frailty
Aging
Skeletal muscle
Nutrition

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014