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Completed

NCT Number: NCT03075189

Increased Focus on Protein Intake Among Geriatric Patients

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Slagelse Hospital

Slagelse, Ingemannsvej 18, 4200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Protein intake

    Time frame: Change from baseline up to 6 weeks

    Dietary recordings with focus on protein intake are collected during hospitalization and at follow up. The total intake of protein per day is assessed.

Secondary outcomes

  1. Change in grib strength

    Time frame: Baseline, up to 8 days, up to 6 weeks

    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.

  2. De Morton Mobility Index (DEMMI)

    Time frame: Baseline, up to 8 days, up to 6 weeks

    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.

  3. Barthel ADL-index

    Time frame: Baseline, up to 8 days, up to 6 weeks

    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.

  4. SARC-F

    Time frame: Baseline, up to 8 days, up to 6 weeks

    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.

  5. EQ-5D-3L

    Time frame: Baseline, up to 8 days, up to 6 weeks

    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.

  6. Length of stay (LOS)

    Time frame: Up to 8 days (after baseline)

    Based on information from electronic patient journal. LOS is defined from day of admission to day of discharge.

  7. Readmission

    Time frame: Up to 6 weeks (after baseline)

    Based on information from electronic patient journal and is defined as a readmission less than 30 days after discharge.

  8. Anthropometric measures

    Time frame: Change from baseline up to 6 weeks

    Weight is measured to make individual calculations of protein and energy needs.

  9. Bioimpedance

    Time frame: Up to 2 days and up to 6 weeks

    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

  10. 24h recall interview

    Time frame: Up to 6 weeks

    Interviewers asks the participant about their dietary intake through the last 24 hours. A standard technique with four steps is used for this interview.

  11. Food frequency questionnaire

    Time frame: Up to 6 weeks

    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.

  12. Nutrition related complications

    Time frame: Up to 8 days and up to 6 weeks.

    Infections, falls and decreased wound healing

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods
  • Slagelse Hospital

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2017
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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