Physical DisabilityNCT02001831
Multi-ingredient Nutrition Supplement in Older Adults
A study testing Supplement in people with Physical Disability, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Disability
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥ 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brendan Egan, PhD contact
About this study
Official title: Effect of a Nutrition Supplement Containing Fish Oil, Whey Protein, Vitamin D, and Resveratrol, on Muscular and Cognitive Function in Older Adults
The aims of the present study are:
- 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.
Read the detailed description
The study is a population study and 6 month randomised control trial (RCT) of men and women aged 70 to 80. The supplement and placebo will be provided in the form of a small 200 mL sealed TetraPak carton and is presented in a highly-palatable, juice-based (pomegranate and apple) formulation. The study groups (n=25 per group) for the RCT are:
Control - a control group receiving a placebo nutrient support (200 mL juice; energy ~ 100 kcal per day)
Supplement - a nutrient group receiving a liquid nutrient support (quantity 200 mL per day; energy 200 kcal per day):
Carbohydrate 28.5 g Protein 8 g as Whey Protein Isolate (i) ω-3 PUFA (ii) 3000 mg, as DHA 1500mg, as EPA 1500mg Vitamin D3 (iii) 10 μg Resveratrol (iv) 150 mg
(i) Whey protein isolate - increasing protein intake in elderly individuals is widely proposed as key preventing the decline in muscle mass with aging, (ii) ω-3/EPA/DHA fatty acids - increasing ω-3 consumption is associated with improvements in inflammatory status, blood lipid profile and cognitive function in various populations (iii) A relative deficiency in vitamin D is widely reported in Western populations, whereas recent reports have suggested vitamin D3 supplementation as efficacious for muscle function, (iv) Resveratrol, a polyphenol derived from grape skin that shows promise as a supplement to improve muscle function, metabolic health, prevent wasting and promote longevity.
Participants will undertake a first preliminary screening, which will take part at the Human Performance Laboratory at the University College Dublin (UCD) Institute for Sport and Health, or, alternatively, in a home-based environment, according to participants preferences, in order to assess inclusion/exclusion criteria.
After having examined the participant information leaflet, participants will provide informed consent in writing, complete the medical history examination, a food intake diary and food frequency questionnaire as well as habitual physical activity level questionnaire (CHAMPS).
Next, they will have their stature, body composition, and functional capacity assessed as described below. If fulfilling the eligibility criteria, subjects will undertake 3 assessment sessions (at baseline, 12 wk \& 24 wk) at the Human Performance Laboratory at the UCD Institute for Sport and Health, consisting of body composition, functional capacity, and cognitive performance assessment.
In detail:
- Body composition (fat, muscle and bone mass by Dual Energy X-Ray Absorptiometry (DXA) (Expected time ~ 15 min) ii. Provide a blood sample taken via venepuncture to a superficial antecubital vein to be later analysed to assess lipidemic profile, plasma glucose, insulin, and inflammatory markers (Expected time ~ 5 min) iii. Measurement of muscle strength and lower extremity muscle function in simulated activities of daily living by hand grip, usual walking speed, chair rise test, sit and reach test, and balance test [Short Performance Battery Test (Guralnik et al. 1994)]. (Expected time ~ 40 min) iv. Assessment of cognitive function by the following battery modeled upon that used in Witte et al. (2013) (Expected time ~ 45 min):
- 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
- Cognitive Failures Questionnaire
- Conditions
- Physical Disability
- Being tested
- Supplement, Placebo
- Keywords
- Sarcopenia, Frailty, Aging, Skeletal muscle, Nutrition
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and appendicular muscle mass
By means of measurement of lean body mass using dual-energy X-ray absorptiometry (DXA)
Measured: Change from Baseline at day 84 & day 168
Secondary outcomes (2)
Lower extremity physical function
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)
Measured: Change from Baseline at day 84 & day 168
Cognitive performance
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
Measured: Change from Baseline at day 84 & day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Smartfish AS
- Responsible party
- Principal investigator, Brendan Egan, University College Dublin
- Investigators
- Giuseppe De Vito, MD, PhD, Study director, School of Public Health, Physiotherapy and Population Sciences. University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001831
- Sponsor's protocol ID
- SMF-3000
- Status last verified
- Nov 2013
- First submitted
- 15 Aug 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1093/ageing/23.3.185.
PubMed 8085501Janssen 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.
PubMed 14769646Witte 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.
PubMed 23796946Guralnik 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.
PubMed 8126356Moran 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.
PubMed 29972210
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutrition Supplement Containing Fish Oil, Whey Protein, Vitamin D, and Resveratrol, on Muscular and Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT02001831
- Acronym / sponsor ID
- SMF-3000
- Conditions
- Physical Disability
- Keywords
- Sarcopenia, Frailty, Aging, Skeletal muscle, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Smartfish AS
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of the present study are:
- 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.
Detailed description
The study is a population study and 6 month randomised control trial (RCT) of men and women aged 70 to 80. The supplement and placebo will be provided in the form of a small 200 mL sealed TetraPak carton and is presented in a highly-palatable, juice-based (pomegranate and apple) formulation. The study groups (n=25 per group) for the RCT are:
Control - a control group receiving a placebo nutrient support (200 mL juice; energy ~ 100 kcal per day)
Supplement - a nutrient group receiving a liquid nutrient support (quantity 200 mL per day; energy 200 kcal per day):
Carbohydrate 28.5 g Protein 8 g as Whey Protein Isolate (i) ω-3 PUFA (ii) 3000 mg, as DHA 1500mg, as EPA 1500mg Vitamin D3 (iii) 10 μg Resveratrol (iv) 150 mg
(i) Whey protein isolate - increasing protein intake in elderly individuals is widely proposed as key preventing the decline in muscle mass with aging, (ii) ω-3/EPA/DHA fatty acids - increasing ω-3 consumption is associated with improvements in inflammatory status, blood lipid profile and cognitive function in various populations (iii) A relative deficiency in vitamin D is widely reported in Western populations, whereas recent reports have suggested vitamin D3 supplementation as efficacious for muscle function, (iv) Resveratrol, a polyphenol derived from grape skin that shows promise as a supplement to improve muscle function, metabolic health, prevent wasting and promote longevity.
Participants will undertake a first preliminary screening, which will take part at the Human Performance Laboratory at the University College Dublin (UCD) Institute for Sport and Health, or, alternatively, in a home-based environment, according to participants preferences, in order to assess inclusion/exclusion criteria.
After having examined the participant information leaflet, participants will provide informed consent in writing, complete the medical history examination, a food intake diary and food frequency questionnaire as well as habitual physical activity level questionnaire (CHAMPS).
Next, they will have their stature, body composition, and functional capacity assessed as described below. If fulfilling the eligibility criteria, subjects will undertake 3 assessment sessions (at baseline, 12 wk \& 24 wk) at the Human Performance Laboratory at the UCD Institute for Sport and Health, consisting of body composition, functional capacity, and cognitive performance assessment.
In detail:
- Body composition (fat, muscle and bone mass by Dual Energy X-Ray Absorptiometry (DXA) (Expected time ~ 15 min) ii. Provide a blood sample taken via venepuncture to a superficial antecubital vein to be later analysed to assess lipidemic profile, plasma glucose, insulin, and inflammatory markers (Expected time ~ 5 min) iii. Measurement of muscle strength and lower extremity muscle function in simulated activities of daily living by hand grip, usual walking speed, chair rise test, sit and reach test, and balance test [Short Performance Battery Test (Guralnik et al. 1994)]. (Expected time ~ 40 min) iv. Assessment of cognitive function by the following battery modeled upon that used in Witte et al. (2013) (Expected time ~ 45 min):
- 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
- Cognitive Failures Questionnaire
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: SupplementLiquid 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 |
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥ 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement | Dietary supplement | Supplement |
| Placebo | Dietary supplement | Control |
Primary outcome
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)
2 secondary outcomes
Lower extremity physical function
Time frame: Change from Baseline at day 84 & day 168
Cognitive performance
Time frame: Change from Baseline at day 84 & day 168
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Background: PubMed 8085501Greig 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.
- Background: PubMed 14769646Janssen 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.
- Background: PubMed 23796946Witte 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.
- Background: PubMed 8126356Guralnik 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.
- Derived from this study: PubMed 29972210Moran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Egan, PhD contact
Giuseppe De Vito, MD, PhD study director
School of Public Health, Physiotherapy and Population Sciences. University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Physical Disability, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brendan Egan, PhD (brendan.egan@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and appendicular muscle mass (time frame: Change from Baseline at day 84 & day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001831, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.