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
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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 |

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 |

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 |
- 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)
- 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

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

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
Contact: Brendan Egan, PhD | brendan.egan@ucd.ie |
Ireland | |
UCD Institute for Sport and Health | |
Dublin, Ireland, Dublin 4 |
Study Director: | Giuseppe De Vito, MD, PhD | School of Public Health, Physiotherapy and Population Sciences. University College Dublin |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Sarcopenia Frailty Aging Skeletal muscle Nutrition |