Increased Focus on Protein Intake Among Geriatric Patients

Geriatric Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075189
• Other study ID #: 16045350
• Status: Completed
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: May 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Geriatric Diseases

Intervention

Dietary Supplement:
• Whey protein supplement
During hospitalization the intervention group will receive a whey protein enriched snack/meal in the morning and before bedtime. They will be given 15 gr of protein every morning, and the meal before bedtime will vary in protein content according to the individual needs. Diet registration will be carried out every day during hospitalization. At discharge, participants in the intervention will be instructed and advised with focus on consuming more protein at home. The control group are having the ordinary hospital diet and are following normal guidelines. They are not offered the protein focused counseling at discharge. Both groups have diet registration and testing at baseline, discharge and follow-up.

Locations

Country	Name	City	State
Denmark	Slagelse Hospital	Slagelse	Ingemannsvej 18

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods, Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein intake	Dietary recordings with focus on protein intake are collected during hospitalization and at follow up. The total intake of protein per day is assessed.	Change from baseline up to 6 weeks
Secondary	Change in grib strength	Isometric hand grib strength. The patients sit in an upright position, resting their arm and holding a hand dynamometer in the non-dominant arm. Then a maximum pressure test is performed with the hand and the strength is recorded.	Baseline, up to 8 days, up to 6 weeks
Secondary	De Morton Mobility Index (DEMMI)	A mobility test used as standard procedure when admitted to the geriatric ward. The test contains 15 tasks of different difficulty, such as rising from a chair, static and dynamic balance and walk.	Baseline, up to 8 days, up to 6 weeks
Secondary	Barthel ADL-index	Testing the patient's ability to perform different activities of daily living, such as eating, movement, personal hygiene and toilet visits. The test consists of 10 steps, and each step results in a score from 5-15 when performed by the patient.	Baseline, up to 8 days, up to 6 weeks
Secondary	SARC-F	A screening tool, where the patient is asked about different physical parameters in relation to the risk of developing sarcopenia: parameters such as falls, assistance to walk, general strength, rise from a chair and walk on stairs.	Baseline, up to 8 days, up to 6 weeks
Secondary	EQ-5D-3L	A questionnaire focusing on self-perceived quality of life. The questions are divided into 5 categories: mobility, personal hygiene, pain, anxiety and ability to perform ADL-activities.	Baseline, up to 8 days, up to 6 weeks
Secondary	Length of stay (LOS)	Based on information from electronic patient journal. LOS is defined from day of admission to day of discharge.	Up to 8 days (after baseline)
Secondary	Readmission	Based on information from electronic patient journal and is defined as a readmission less than 30 days after discharge.	Up to 6 weeks (after baseline)
Secondary	Anthropometric measures	Weight is measured to make individual calculations of protein and energy needs.	Change from baseline up to 6 weeks
Secondary	Bioimpedance	Measurement of fat and muscle distribution in the body. Is measured on day 2-3 after inclusion because of possible irregularities in fluid balance at admission to the hospital and after surgery	Up to 2 days and up to 6 weeks
Secondary	24h recall interview	Interviewers asks the participant about their dietary intake through the last 24 hours. A standard technique with four steps is used for this interview.	Up to 6 weeks
Secondary	Food frequency questionnaire	A list containing the most protein rich food items are given to the participant and they are asked how frequent they have had the items during the last 4 weeks after discharge.	Up to 6 weeks
Secondary	Nutrition related complications	Infections, falls and decreased wound healing	Up to 8 days and up to 6 weeks.