Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods (ConsuMEER)
Primary Purpose
Malnutrition; Protein, Protein Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nutritional intervention - protein-rich
Nutritional intervention - standard
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition; Protein focused on measuring Protein intake, Older adults, Protein-rich, Acceptance, Liking, Readymade meals
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
Sites / Locations
- HAN University of Applied Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Protein-rich assortment
Standard assortment
Arm Description
The intervention groups receives protein-rich meals and protein-rich dairy products.
The control group receives standard meals and food products.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03032237
First Posted
January 16, 2017
Last Updated
February 27, 2023
Sponsor
HAN University of Applied Sciences
Collaborators
HAS Hogeschool, Centre of Expertise Food (CoE Food), Sligro, FrieslandCampina
1. Study Identification
Unique Protocol Identification Number
NCT03032237
Brief Title
Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods
Acronym
ConsuMEER
Official Title
Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HAN University of Applied Sciences
Collaborators
HAS Hogeschool, Centre of Expertise Food (CoE Food), Sligro, FrieslandCampina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition; Protein, Protein Malnutrition
Keywords
Protein intake, Older adults, Protein-rich, Acceptance, Liking, Readymade meals
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein-rich assortment
Arm Type
Experimental
Arm Description
The intervention groups receives protein-rich meals and protein-rich dairy products.
Arm Title
Standard assortment
Arm Type
Placebo Comparator
Arm Description
The control group receives standard meals and food products.
Intervention Type
Other
Intervention Name(s)
Nutritional intervention - protein-rich
Intervention Description
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
Intervention Name(s)
Nutritional intervention - standard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Protein intake
Description
Difference in daily protein intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Acceptance
Description
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.
Time Frame
4 weeks
Title
Energy intake
Description
Difference in daily energy intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian de van der Schueren, PhD
Organizational Affiliation
HAN University of Applied Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annet Roodenburg, PhD
Organizational Affiliation
HAS Hogeschool
Official's Role
Principal Investigator
Facility Information:
Facility Name
HAN University of Applied Sciences
City
Nijmegen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.
Learn more about this trial
Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods
We'll reach out to this number within 24 hrs