Malnutrition; ProteinConsuMEERNCT03032237
Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods
A study testing Nutritional intervention - protein-rich and Nutritional intervention - standard in people with Malnutrition; Protein and Protein Malnutrition, run by HAN University of Applied Sciences at 1 site in Netherlands.
Trial summary
Rationale: Undernutrition risk among community-dwelling older adults in developed countries is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well as efficacious to reduce undernutrition in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition; Protein, Protein Malnutrition
- What is being tested?
- Nutritional intervention - protein-rich and Nutritional intervention - standard
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2017to 31 May 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or over
- Living at home
- Be a client of maaltijdservice.nl
- Being able to eat by themselves
- Have a microwave to heat meals
- Live in Nijmegen or Den Bosch area
- Being able to understand, read and speak Dutch
- Having signed informed consent.
Who cannot join
- Legally incapacitated
- Mini Mental State Examination (MMSE) score < 24
- Following a diet with protein restriction or a vegetarian diet
- Allergies or intolerances prohibiting the use of dairy products
- Only using texture modified foods (liquid diet)
- Diagnosed by doctor with renal insufficiency
- Suffering from a terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.
Rationale: Undernutrition risk among community-dwelling older adults in developed countries is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well as efficacious to reduce undernutrition in community-dwelling older adults. A promising strategy to increase protein intake among older adults, is to offer dietary solutions with normal foods that fit their current daily eating patterns. For this reason, home-delivered protein-rich readymade meals and protein-rich dairy products will be studied in this research.
Objective: The primary objective is to study the effectiveness of commercially available protein-rich readymade meals and protein-rich dairy products in increasing protein intake of older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary objectives include: studying effects of these meals and dairy products on total daily energy intake. Further, studying the acceptance of and compliance to the meals and dairy products.
Read more
Study design: The study will be performed as a single-blind randomized, controlled, four-week trial in a real-life setting: in community-dwelling older adults' own homes.
Study population: The target group of this study are community-dwelling older adults who use a meal-delivery service.
Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will also receive dairy products to freely consume during the intervention period. The intervention groups receives protein-rich meals and protein-rich dairy products, the control receives standard meals and food products.
Main study parameters/endpoints: Difference in daily protein intake between intervention and control group. Secondary parameters: energy intake and acceptance (liking).
- Conditions
- Malnutrition; Protein, Protein Malnutrition
- Being tested
- Nutritional intervention - protein-rich, Nutritional intervention - standard
- Keywords
- Protein intake, Older adults, Protein-rich, Acceptance, Liking, Readymade meals
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional intervention - protein-richOther
Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.
To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.
Intervention group will receive protein-rich meals and protein-rich foods and drinks.
Nutritional intervention - standardOther
Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.
To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.
Control group will receive standard (not protein-rich) meals and standard foods and drinks.
| Study group | Role | What they receive |
|---|---|---|
| Protein-rich assortment | Experimental | The intervention groups receives protein-rich meals and protein-rich dairy products. Receives: Other: Nutritional intervention - protein-rich |
| Standard assortment | Placebo comparator | The control group receives standard meals and food products. Receives: Other: Nutritional intervention - standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein intake
Difference in daily protein intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
Measured: 4 weeks
Secondary outcomes (2)
Acceptance
Acceptance and liking of meals and food products; outcome will be measured with a questionnaire including a 5-point likert scale (for liking) and a question how much was eaten. This questionnaire needs to be done every day.
Measured: 4 weeks
Energy intake
Difference in daily energy intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start4 Apr 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; ProteinStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAN University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- HAS Hogeschool, Centre of Expertise Food (CoE Food), Sligro, FrieslandCampina
- Responsible party
- Principal investigator, dr. Marian de van der Schueren, HAN University of Applied Sciences
- Investigators
- Marian de van der Schueren, PhD, Principal investigator, HAN University of Applied SciencesAnnet Roodenburg, PhD, Principal investigator, HAS Hogeschool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032237
- Sponsor's protocol ID
- ConsuMEER onderzoek
- Acronym
- ConsuMEER
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.
- ClinicalTrials.gov ID
- NCT03032237
- Acronym / sponsor ID
- ConsuMEER / ConsuMEER onderzoek
- Conditions
- Malnutrition; Protein, Protein Malnutrition
- Keywords
- Protein intake, Older adults, Protein-rich, Acceptance, Liking, Readymade meals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HAN University of Applied SciencesUniversity, hospital or other
- Collaborators
- HAS Hogeschool, Centre of Expertise Food (CoE Food), Sligro, FrieslandCampina
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 26 Jan 2017 (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.
Rationale: Undernutrition risk among community-dwelling older adults in developed countries is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well as efficacious to reduce undernutrition in community-dwelling older adults. A promising strategy to increase protein intake among older adults, is to offer dietary solutions with normal foods that fit their current daily eating patterns. For this reason, home-delivered protein-rich readymade meals and protein-rich dairy products will be studied in this research.
Objective: The primary objective is to study the effectiveness of commercially available protein-rich readymade meals and protein-rich dairy products in increasing protein intake of older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary objectives include: studying effects of these meals and dairy products on total daily energy intake. Further, studying the acceptance of and compliance to the meals and dairy products.
Study design: The study will be performed as a single-blind randomized, controlled, four-week trial in a real-life setting: in community-dwelling older adults' own homes.
Study population: The target group of this study are community-dwelling older adults who use a meal-delivery service.
Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will also receive dairy products to freely consume during the intervention period. The intervention groups receives protein-rich meals and protein-rich dairy products, the control receives standard meals and food products.
Main study parameters/endpoints: Difference in daily protein intake between intervention and control group. Secondary parameters: energy intake and acceptance (liking).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein-rich assortment | Experimental | Other: Nutritional intervention - protein-richThe intervention groups receives protein-rich meals and protein-rich dairy products. |
| Standard assortment | Placebo comparator | Other: Nutritional intervention - standardThe control group receives standard meals and food products. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Aged 65 years or over
- Living at home
- Be a client of maaltijdservice.nl
- Being able to eat by themselves
- Have a microwave to heat meals
Key exclusion criteria (7 listed)
- Legally incapacitated
- Mini Mental State Examination (MMSE) score < 24
- Following a diet with protein restriction or a vegetarian diet
- Allergies or intolerances prohibiting the use of dairy products
- Only using texture modified foods (liquid diet)
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 |
|---|---|---|
| Nutritional intervention - protein-richBoth groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period. To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to. Intervention group will receive protein-rich meals and protein-rich foods and drinks. | Other | Protein-rich assortment |
| Nutritional intervention - standardBoth groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period. To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to. Control group will receive standard (not protein-rich) meals and standard foods and drinks. | Other | Standard assortment |
Primary outcome
Protein intake
Time frame: 4 weeks
Difference in daily protein intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
2 secondary outcomes
Acceptance
Time frame: 4 weeks
Energy intake
Time frame: 4 weeks
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 28 Feb 2023.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
Marian de van der Schueren, PhD principal investigator
HAN University of Applied Sciences
Annet Roodenburg, PhD principal investigator
HAS Hogeschool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention - protein-rich and Nutritional intervention - standard in people with Malnutrition; Protein and Protein Malnutrition, run by HAN University of Applied Sciences at 1 site 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 8 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 28 Feb 2023. 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 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. 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?
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 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.