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

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.

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 Overview

• Status: Completed
• Conditions: Malnutrition; Protein; Protein Malnutrition
• Intervention / Treatment: Other: Nutritional intervention - protein-rich; Other: Nutritional intervention - standard

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • HAN University of Applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein-rich assortment; The intervention groups receives protein-rich meals and protein-rich dairy products.	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.
Placebo Comparator: Standard assortment; 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. Control group will receive standard (not protein-rich) meals and standard foods and drinks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: HAN University of Applied Sciences
• Collaborators: FrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); Sligro

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Older adults; Liking; Acceptance; Protein intake; Protein-rich; Readymade meals
• Additional Relevant MeSH Terms: Nutrition Disorders; Severe Acute Malnutrition; Malnutrition; Kwashiorkor
• Other Study ID Numbers: ConsuMEER onderzoek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No