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

NCT ID: NCT03032237

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2017-05-31

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).

Conditions

Malnutrition; Protein; Protein Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Protein-rich assortment

The intervention groups receives protein-rich meals and protein-rich dairy products.

Group Type: EXPERIMENTAL

Nutritional intervention - protein-rich

Intervention Type: OTHER

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.

Standard assortment

The control group receives standard meals and food products.

Group Type: PLACEBO_COMPARATOR

Nutritional intervention - standard

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HAS Hogeschool

UNKNOWN

Sponsor Role: collaborator

Centre of Expertise Food (CoE Food)

UNKNOWN

Sponsor Role: collaborator

Sligro

UNKNOWN

Sponsor Role: collaborator

FrieslandCampina

INDUSTRY

Sponsor Role: collaborator

HAN University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

dr. Marian de van der Schueren

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marian de van der Schueren, PhD

Role: PRINCIPAL_INVESTIGATOR

HAN University of Applied Sciences

Annet Roodenburg, PhD

Role: PRINCIPAL_INVESTIGATOR

HAS Hogeschool

Locations

HAN University of Applied Sciences

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

ConsuMEER onderzoek

Identifier Type: -

Identifier Source: org_study_id