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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032237
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
HAS Hogeschool
Centre of Expertise Food (CoE Food)
Sligro
FrieslandCampina
Information provided by (Responsible Party):
HAN University of Applied Sciences

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).


Condition or disease Intervention/treatment Phase
Malnutrition; Protein Protein Malnutrition Other: Nutritional intervention - protein-rich Other: Nutritional intervention - standard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Acceptance [ Time Frame: 4 weeks ]
    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.

  2. Energy intake [ Time Frame: 4 weeks ]
    Difference in daily energy intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032237


Locations
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Netherlands
HAN University of Applied Sciences
Nijmegen, Netherlands
Sponsors and Collaborators
HAN University of Applied Sciences
HAS Hogeschool
Centre of Expertise Food (CoE Food)
Sligro
FrieslandCampina
Investigators
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Principal Investigator: Marian de van der Schueren, PhD HAN University of Applied Sciences
Principal Investigator: Annet Roodenburg, PhD HAS Hogeschool
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Responsible Party: HAN University of Applied Sciences
ClinicalTrials.gov Identifier: NCT03032237    
Other Study ID Numbers: ConsuMEER onderzoek
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HAN University of Applied Sciences:
Protein intake
Older adults
Protein-rich
Acceptance
Liking
Readymade meals
Additional relevant MeSH terms:
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Malnutrition
Kwashiorkor
Nutrition Disorders
Severe Acute Malnutrition