Markedly Reduced Food IntakeNCT01907152
Increase Protein Intake in Elderly
A study testing Protein enriched yoghurt drink and bread in people with Markedly Reduced Food Intake, run by Wageningen University and Research at 2 sites in Netherlands.
Trial summary
The objective of this study is to investigate the acceptance, intake, and compliance of protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real life settings (short term; hospital, and longer term; rehabilitation home). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Markedly Reduced Food Intake
- What is being tested?
- Protein enriched yoghurt drink and bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2013to Jan 2014
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to the department of internal medicine of VU university medical center or to the rehabilitation department of "Herstelhotel Dekkerswald"
- signed informed consent
- age of 55 or more
- rehabilitating from a hospital stay with the aim to return back home (rehabilitation home only)
- likely to remain admitted at least 3 weeks (rehabilitation home only).
Who cannot join
- not speaking Dutch language
- allergy for milk, soy or gluten
- a medical condition that is considered by the treating physician as a contra indication for receiving protein enriched food products
- a diet that does not allow the use of normal bread or dairy products (e.g. fluid diet, strong sodium restricted diet)
- not able to eat or feed themselves
- receiving tube feeding or parenteral nutrition
- suffering from a terminal illness
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VU university medical center
Amsterdam
Rehabilitation home "Herstelhotel Dekkerswald"
Groesbeek
About this study
The objective of this study is to investigate the acceptance, intake, and compliance of protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real life settings (short term; hospital, and longer term; rehabilitation home).
Read the detailed description
Prevalence rates of protein-energy malnutrition in elderly are high. In order to prevent loss of muscle mass and remain physically independent, it is utmost important for elderly to maintain their body protein mass. A sufficient protein supply according to their needs is therefore highly important. Especially for frail elderly, it is not easy to realize an increased protein intake by simply eating more. It is hypothesized that protein enriched food products that fit in a habitual diet (dairy and bread), result in a higher protein intake compared to regular products.
- Conditions
- Markedly Reduced Food Intake
- Being tested
- Protein enriched yoghurt drink and bread
- Keywords
- malnutrition, undernourishment, loss of muscle mass
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein enriched yoghurt drink and breadOther
| Study group | Role | What they receive |
|---|---|---|
| Protein enriched yoghurt drink and bread | Experimental | Yoghurt drink enriched with Whey Protein Concentrate Whole wheat bread enriched with cereal protein and soy Receives: Other: Protein enriched yoghurt drink and bread |
| Regular yoghurt drink and bread | No intervention | Commercially available yoghurt drink and whole wheat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein intake measured on an individual level over 24h
Measured: 3 days (hospital), 3 weeks (rehabilitation home)
Secondary outcomes (1)
Intake of macronutrients (besides protein), total energy, calcium and fibre measured on an individual level over 24h.
Measured: 3 days (hospital), 3 weeks (rehabilitation home)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Markedly Reduced Food IntakeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Fonterra (Europe) Cooperatie U.A., Carezzo B.V., Amsterdam UMC, location VUmc, Hogeschool van Arnhem en Nijmegen (HAN)
- Responsible party
- Sponsor
- Investigators
- Esther Boelsma, PhD, Principal investigator, Wageningen UR Food and Biobased Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907152
- Sponsor's protocol ID
- NL43997.081.13
- Other IDs
- TKI-AF 12065
- Status last verified
- May 2014
- First submitted
- 22 Jul 2013
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stelten S, Dekker IM, Ronday EM, Thijs A, Boelsma E, Peppelenbos HW, de van der Schueren MA. Protein-enriched 'regular products' and their effect on protein intake in acute hospitalized older adults; a randomized controlled trial. Clin Nutr. 2015 Jun;34(3):409-14. doi: 10.1016/j.clnu.2014.08.007. Epub 2014 Aug 15.
PubMed 25179468
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increase Protein Intake in Elderly
- ClinicalTrials.gov ID
- NCT01907152
- Acronym / sponsor ID
- NL43997.081.13
- Conditions
- Markedly Reduced Food Intake
- Keywords
- malnutrition, undernourishment, loss of muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Fonterra (Europe) Cooperatie U.A., Carezzo B.V., Amsterdam UMC, location VUmc, Hogeschool van Arnhem en Nijmegen (HAN)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jul 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 objective of this study is to investigate the acceptance, intake, and compliance of protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real life settings (short term; hospital, and longer term; rehabilitation home).
Detailed description
Prevalence rates of protein-energy malnutrition in elderly are high. In order to prevent loss of muscle mass and remain physically independent, it is utmost important for elderly to maintain their body protein mass. A sufficient protein supply according to their needs is therefore highly important. Especially for frail elderly, it is not easy to realize an increased protein intake by simply eating more. It is hypothesized that protein enriched food products that fit in a habitual diet (dairy and bread), result in a higher protein intake compared to regular products.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein enriched yoghurt drink and bread | Experimental | Other: Protein enriched yoghurt drink and breadYoghurt drink enriched with Whey Protein Concentrate Whole wheat bread enriched with cereal protein and soy |
| Regular yoghurt drink and bread | No intervention | –Commercially available yoghurt drink and whole wheat bread |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- admitted to the department of internal medicine of VU university medical center or to the rehabilitation department of "Herstelhotel Dekkerswald"
- signed informed consent
- age of 55 or more
- rehabilitating from a hospital stay with the aim to return back home (rehabilitation home only)
- likely to remain admitted at least 3 weeks (rehabilitation home only).
Key exclusion criteria (7 listed)
- not speaking Dutch language
- allergy for milk, soy or gluten
- a medical condition that is considered by the treating physician as a contra indication for receiving protein enriched food products
- a diet that does not allow the use of normal bread or dairy products (e.g. fluid diet, strong sodium restricted diet)
- not able to eat or feed themselves
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 |
|---|---|---|
| Protein enriched yoghurt drink and bread | Other | Protein enriched yoghurt drink and bread |
Primary outcome
Protein intake measured on an individual level over 24h
Time frame: 3 days (hospital), 3 weeks (rehabilitation home)
1 secondary outcome
Intake of macronutrients (besides protein), total energy, calcium and fibre measured on an individual level over 24h.
Time frame: 3 days (hospital), 3 weeks (rehabilitation home)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Derived from this study: PubMed 25179468Stelten S, Dekker IM, Ronday EM, Thijs A, Boelsma E, Peppelenbos HW, de van der Schueren MA. Protein-enriched 'regular products' and their effect on protein intake in acute hospitalized older adults; a randomized controlled trial. Clin Nutr. 2015 Jun;34(3):409-14. doi: 10.1016/j.clnu.2014.08.007. Epub 2014 Aug 15.
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.
Esther Boelsma, PhD principal investigator
Wageningen UR Food and Biobased Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein enriched yoghurt drink and bread in people with Markedly Reduced Food Intake, run by Wageningen University and Research at 2 sites in Netherlands.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein intake measured on an individual level over 24h (time frame: 3 days (hospital), 3 weeks (rehabilitation home)). 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 NCT01907152, which also lists 1 linked publication.
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 16 May 2014.