Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods

Protein Malnutrition Clinical Trial

— ConsuMEER  

Official title:

Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032237
• Other study ID #: ConsuMEER onderzoek
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: February 2023
• Source: HAN University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Malnutrition; Protein
• Protein Malnutrition

Intervention

Other:
• Nutritional intervention - protein-rich
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 - 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. Control group will receive standard (not protein-rich) meals and standard foods and drinks.

Locations

Country	Name	City	State
Netherlands	HAN University of Applied Sciences	Nijmegen

Sponsors (5)

Lead Sponsor	Collaborator
HAN University of Applied Sciences	Centre of Expertise Food (CoE Food), FrieslandCampina, HAS Hogeschool, Sligro

Country where clinical trial is conducted

Netherlands, 

Outcome

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