Increased Focus on Protein Intake Among Geriatric Patients

NCT ID: NCT03075189

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2017-08-30

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.

Conditions

Geriatric Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Protein supplement

During hospitalization the intervention group will receive a 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.

Diet registration and testing at baseline, discharge and follow-up.

Group Type: EXPERIMENTAL

Whey protein supplement

Intervention Type: DIETARY_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.

Standard treatment

The control group are having the ordinary hospital diet and are following normal guidelines. They are not offered the protein focused counseling at discharge.

Diet registration and testing at baseline, discharge and follow-up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slagelse Hospital

OTHER

Sponsor Role: collaborator

Arla Foods

INDUSTRY

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Lars Holm

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Slagelse Hospital

Slagelse, Ingemannsvej 18, Denmark

Countries

Denmark

Other Identifiers

16045350

Identifier Type: -

Identifier Source: org_study_id