Protein Malnutrition Clinical Trial
— ConsuMEEROfficial title:
Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.
Verified date | February 2023 |
Source | HAN University of Applied Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 100 |
Est. completion date | May 31, 2017 |
Est. primary completion date | May 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | HAN University of Applied Sciences | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
HAN University of Applied Sciences | Centre of Expertise Food (CoE Food), FrieslandCampina, HAS Hogeschool, Sligro |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 weeks | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 4 weeks |
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