An interventional study of Nutritional intervention - protein-rich and Nutritional intervention - standard in Malnutrition; Protein and Protein Malnutrition, sponsored by HAN University of Applied Sciences. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by HAN University of Applied Sciences · Not applicable, Interventional, and Supportive care
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).
45 studies on the registry are indexed under Kwashiorkor; 5 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 33 interventional studies indexed under Kwashiorkor.
Browse Kwashiorkor studies →HAN University of Applied Sciences is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention groups receives protein-rich meals and protein-rich dairy products.
Other: Nutritional intervention - protein-rich
The control group receives standard meals and food products.
Other: Nutritional intervention - standard
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.
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.
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 4 weeks
Plan to share: No — IPD will not be shared.
No publications or documents are linked to this record.
Ran from Apr 2017 to primary completion in May 2017, 1 month.
Of 21 interventional studies with no phase under Kwashiorkor, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's 1 month is below that.
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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HAN University of Applied Sciences