Clinical trial NCT03032237: Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods
Official title: Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition; Protein
Protein Malnutrition
Keywords: Protein intake
Older adults
Protein-rich
Acceptance
Liking
Readymade meals
Lead sponsor: HAN University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: HAS Hogeschool
name: Centre of Expertise Food (CoE Food)
name: Sligro
name: FrieslandCampina
First posted: 2017-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Protein intake
timeFrame: 4 weeks
Secondary outcomes:
measure: Acceptance
timeFrame: 4 weeks
measure: Energy intake
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: HAN University of Applied Sciences
Study officials:
affiliation: HAN University of Applied Sciences
name: Marian de van der Schueren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HAS Hogeschool
name: Annet Roodenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References: