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Clinical Trials/NCT03032237
NCT03032237CompletedNot Applicable

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

HAN University of Applied Sciences1 site in 1 country100 target enrollmentStarted: April 4, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Protein intake

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Protein intake

Time Frame: 4 weeks

Difference in daily protein intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.

Secondary Outcomes

  • Acceptance(4 weeks)
  • Energy intake(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

dr. Marian de van der Schueren

Prof. Dr.

HAN University of Applied Sciences

Study Sites (1)

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