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

NCT03032237 | Completed

• 1 other identifier: ConsuMEER onderzoek
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Protein intake; Older adults; Protein-rich; Acceptance; Liking; Readymade meals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptance

  4 weeks

• Energy intake

  4 weeks

Study Arms (2)

Protein-rich assortment

EXPERIMENTAL

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

Other: Nutritional intervention - protein-rich

Standard assortment

PLACEBO COMPARATOR

The control group receives standard meals and food products.

Other: Nutritional intervention - standard

Interventions

Nutritional intervention - protein-rich 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.

Protein-rich assortment

Nutritional intervention - standard 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.

Standard assortment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HAN University of Applied Sciences: lead
• HAS Hogeschool: collaborator
• Centre of Expertise Food (CoE Food): collaborator
• Sligro: collaborator
• FrieslandCampina: collaborator

Study Sites (1)

HAN University of Applied Sciences

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Marian de van der Schueren, PhD

  HAN University of Applied Sciences

  PRINCIPAL INVESTIGATOR

• Annet Roodenburg, PhD

  HAS Hogeschool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 26, 2017
• Study Start: April 4, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)