Geriatric DiseasesNCT03075189
Increased Focus on Protein Intake Among Geriatric Patients
A study testing Whey protein supplement in people with Geriatric Diseases, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Diseases
- What is being tested?
- Whey protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Mar 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read more
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
- Being tested
- Whey protein supplement
- Keywords
- Frailty, geriatric, hospitalized, enrichment, whey protein, protein intake, sarcopenia, dietary counseling
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline up to 6 weeks
Secondary outcomes (12)
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.
Measured: Baseline, up to 8 days, up to 6 weeks
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.
Measured: Baseline, up to 8 days, up to 6 weeks
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.
Measured: Baseline, up to 8 days, up to 6 weeks
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.
Measured: Baseline, up to 8 days, up to 6 weeks
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.
Measured: Baseline, up to 8 days, up to 6 weeks
Length of stay (LOS)
Based on information from electronic patient journal. LOS is defined from day of admission to day of discharge.
Measured: Up to 8 days (after baseline)
Readmission
Based on information from electronic patient journal and is defined as a readmission less than 30 days after discharge.
Measured: Up to 6 weeks (after baseline)
Anthropometric measures
Weight is measured to make individual calculations of protein and energy needs.
Measured: Change from baseline up to 6 weeks
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
Measured: Up to 2 days and up to 6 weeks
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.
Measured: Up to 6 weeks
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.
Measured: Up to 6 weeks
Nutrition related complications
Infections, falls and decreased wound healing
Measured: Up to 8 days and up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start7 Mar 2017
- Primary completion30 Jun 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DiseasesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inclusion and testing of intervention and control group is carried out at the same time
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Slagelse Hospital, Arla Foods
- Responsible party
- Principal investigator, Lars Holm, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075189
- Sponsor's protocol ID
- 16045350
- Status last verified
- May 2018
- First submitted
- 10 Feb 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03075189
- Acronym / sponsor ID
- 16045350
- Conditions
- Geriatric Diseases
- Keywords
- Frailty, geriatric, hospitalized, enrichment, whey protein, protein intake, sarcopenia, dietary counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Slagelse Hospital, Arla Foods
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Inclusion and testing of intervention and control group is carried out at the same time
| Arm | Type | Receives |
|---|---|---|
| Protein supplement | Experimental | Dietary Supplement: Whey protein supplementDuring 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementDuring 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. | Dietary supplement | Protein supplement |
Primary outcome
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.
12 secondary outcomes
Change in grib strength
Time frame: Baseline, up to 8 days, up to 6 weeks
De Morton Mobility Index (DEMMI)
Time frame: Baseline, up to 8 days, up to 6 weeks
Barthel ADL-index
Time frame: Baseline, up to 8 days, up to 6 weeks
SARC-F
Time frame: Baseline, up to 8 days, up to 6 weeks
EQ-5D-3L
Time frame: Baseline, up to 8 days, up to 6 weeks
Length of stay (LOS)
Time frame: Up to 8 days (after baseline)
Readmission
Time frame: Up to 6 weeks (after baseline)
Anthropometric measures
Time frame: Change from baseline up to 6 weeks
Bioimpedance
Time frame: Up to 2 days and up to 6 weeks
24h recall interview
Time frame: Up to 6 weeks
Food frequency questionnaire
Time frame: Up to 6 weeks
Nutrition related complications
Time frame: Up to 8 days and up to 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplement in people with Geriatric Diseases, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein intake (time frame: Change from baseline up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.