Clinical trial NCT03075189: Increased Focus on Protein Intake Among Geriatric Patients
Official title: Increased Focus on Protein Intake Among Geriatric Patients During Hospitalization: Serving and Acceptance of Protein Enriched Meals in the Morning and Before Bedtime, as Well as Nutritional Guidance by a Clinical Dietician.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Diseases
Keywords: Frailty
geriatric
hospitalized
enrichment
whey protein
protein intake
sarcopenia
dietary counseling
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Slagelse Hospital
name: Arla Foods
First posted: 2017-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Inclusion and testing of intervention and control group is carried out at the same time
Primary purpose: PREVENTION

Brief summary: Up to approximately 38 (unknown drop-out rate) geriatric patients (at least 65 years old) are recruited from a Geriatric ward at Slagelse Sygehus. After inclusion and baseline measurements, each individual will be randomized into either an intervention or control group arranged in blocks of 8 The intervention group (n≤19) will receive protein enriched snacks/dishes in the morning and late evening, before bedtime. Moreover, upon discharge the intervention group will receive individual dietary counseling focusing on choosing protein-rich foods and on protein rich meals. The control group (n≤19) will receive normal hospital food without enrichment and no dietary counseling at discharge. In both groups the following data will be obtained: recorded protein intake, anthropometric measurements (weight, height, body composition estimated with bioimpedance), functional ability (De Morton Mobility Index (DEMMI) and Barthels ADL-index), hand grip strength, sarkopenic status (SARC-F), quality of life (EQ-5D-3L), length of stay (LOS) and readmissions (within 30 days after discharge). During hospitalization food intake will be registered, as well as 24 hour recall interviews and food frequency questionnaires will be done at follow-up visits.

Assessments will be performed at baseline, on the day of discharge and 4 weeks after discharge (follow up).

The primary outcome is change in protein intake from Baseline to 4 weeks after discharge.

The hypothesis is that serving of individually selected protein enriched snack/dish in the morning and before bedtime during hospitalization results in higher protein intake during hospitalization and that this experience combined with dietary counseling at discharge, results in a higher protein intake at 28 days after discharge. Further, we hypothesize that the increased protein intake will affect functional level, hand grip strength, sarcopenic status and quality of life in geriatric patients and will lead to shorter LOS and fewer readmission frequency.


Eligibility criteria: Inclusion Criteria:

* Age: ≥65 år and admitted to the geriatric ward at Slagelse Hospital.
* Expected length-of-stay, LOS: more than 3 days
* Normal kidney function. (As long as the kidney values remain stable during the intervention it is deemed safe to take part, as the amount of protein given will not exceed the amount recommended by the Danish authorities.

Exclusion Criteria:

* Dysphagia
* Patients exclusively fed by tube/probe or parenteral nutrition.
* Gastrointestinal problems, that makes normal food intake impossible.
* People suffering from dementia, deliriousness or severe memory loss
* Patients abusing alcohol
* Patients in isolation
* Terminal patients
* Patients that do not speak Danish or English
* Patients suffering from food allergies/intolerances that makes it impossible to accommodate to the protein enriched foods.

Primary outcomes:
measure: Protein intake
timeFrame: Change from baseline up to 6 weeks
Secondary outcomes:
measure: Change in grib strength
timeFrame: Baseline, up to 8 days, up to 6 weeks
measure: De Morton Mobility Index (DEMMI)
timeFrame: Baseline, up to 8 days, up to 6 weeks
measure: Barthel ADL-index
timeFrame: Baseline, up to 8 days, up to 6 weeks
measure: SARC-F
timeFrame: Baseline, up to 8 days, up to 6 weeks
measure: EQ-5D-3L
timeFrame: Baseline, up to 8 days, up to 6 weeks
measure: Length of stay (LOS)
timeFrame: Up to 8 days (after baseline)
measure: Readmission
timeFrame: Up to 6 weeks (after baseline)
measure: Anthropometric measures
timeFrame: Change from baseline up to 6 weeks
measure: Bioimpedance
timeFrame: Up to 2 days and up to 6 weeks
measure: 24h recall interview
timeFrame: Up to 6 weeks
measure: Food frequency questionnaire
timeFrame: Up to 6 weeks
measure: Nutrition related complications
timeFrame: Up to 8 days and up to 6 weeks.
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Slagelse Hospital
state: Ingemannsvej 18
Study officials:
References: