Increased Focus on Protein Intake Among Geriatric Patients

NCT03075189 | Completed DMC

• 1 other identifier: 16045350
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Frailty; geriatric; hospitalized; enrichment; whey protein; protein intake; sarcopenia; dietary counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in grib strength

  Baseline, up to 8 days, up to 6 weeks

• De Morton Mobility Index (DEMMI)

  Baseline, up to 8 days, up to 6 weeks

• Barthel ADL-index

  Baseline, up to 8 days, up to 6 weeks

• SARC-F

  Baseline, up to 8 days, up to 6 weeks

• EQ-5D-3L

  Baseline, up to 8 days, up to 6 weeks

Study Arms (2)

Protein supplement

EXPERIMENTAL

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.

Dietary Supplement: Whey protein supplement

Standard treatment

NO INTERVENTION

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.

Interventions

Whey protein supplement 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.

Protein supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Slagelse Hospital: collaborator
• Arla Foods: collaborator

Study Sites (1)

Slagelse Hospital

Slagelse, Ingemannsvej 18, 4200, Denmark

Location

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two of the study officials will be masked and therefore responsible for testing the participants at baseline, at discharge and follow-up - and in charge of data processing. Contrary to the masked officials two non-masked officials are responsible for randomization, serving of meals, diet registration and dietary counseling.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Inclusion and testing of intervention and control group is carried out at the same time

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 9, 2017
• Study Start: March 7, 2017
• Primary Completion: June 30, 2017
• Study Completion: August 30, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)