Protein IntakeNCT04764526
Ice Cream Enriched With Protein and Positive Emotions
A study testing Protein-enriched ice cream in people with Protein Intake, run by Inge Tetens at 1 site in Denmark.
Trial summary
The primary aim is to investigate if protein-enriched ice cream has the feasibility to increase intake of protein without substituting other foods in hospitalized older patients and secondary, if the protein-enriched ice cream has the feasibility to increases the energy intake and evokes positive emotions in older… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Protein Intake
- What is being tested?
- Protein-enriched ice cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Apr 2021to 30 Jul 2021
- 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
- older admitted hospital patients age 65 or older, capable \& Danish speaking (able to read and understand the oral and written information and give written consent), able to eat, eat ice cream and expected to stay at the hospital least four days.
Who cannot join
- terminally ill, tube feed, need of special diets, any medical indication suggesting that they should not participate or are on a weight reduction scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Protein-enriched Ice Cream Increase Protein- and Energy Intake and at the Same Time Evoke Positive Emotions - a Feasibility Study Among Hospitalized Older Patients
The primary aim is to investigate if protein-enriched ice cream has the feasibility to increase intake of protein without substituting other foods in hospitalized older patients and secondary, if the protein-enriched ice cream has the feasibility to increases the energy intake and evokes positive emotions in older hospitalized patients
Read the detailed description
Methods/Design:
This study is conducted as a four days non-blinded randomised cross-over feasibility study with 24 hospitalized older patients. The intervention is conducted at the hospital. The intervention is two days with two protein-enriched ice cream daily with the aim of increasing the intake of protein and energy. The patients are asked to answer a questionnaire concerning the emotions the protein enriched ice cream evoke.The patients will be randomised to receive the standard menu the first two days followed by two days with standard menu plus protein-enriched ice cream or in the opposite order. The randomisation will be done by using sealed envelopes.
Recruitment:
Only admitted patients will be a part of the trial. The ward staff will identify the patients there are eligible to the trial as close as possible to the day of admission. The ward staff will ask those patients who meet the inclusion criteria if they will participate in the trail. The patients receive oral and written information on the trial and those who agree to participate are asked to sign a statement of consent before participating. The patients can at any time withdraw their consent and leave the trial.
Sample size:
The sample size is estimated to 24 patients, who will be their own control.
Statistical analysis:
Non-parametric statistical tests, median and range will be performed due to the small sample size and skew distribution. The Wilcoxon signed rank test for paired data, and Fisher's exact test for categorical data. Evoked emotion are measured as the percentages of patients who choose a particular emotion term.
- Conditions
- Protein Intake
- Being tested
- Protein-enriched ice cream
- Keywords
- Protein-enrichment, Older hospitalized patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-enriched ice creamOther
Offering two protein-enriched ice creams
| Study group | Role | What they receive |
|---|---|---|
| Protein-enriched ice cream | Experimental | Two protein-enriched ice cream daily (afternoon and evening) in two days in addition to the normal menu Receives: Other: Protein-enriched ice cream |
| Control | No intervention | Standard menu in two days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein intake (g, %)
The change in protein intake with and without protein-enriched ice cream.
Measured: four consecutive days while hospitalized
Secondary outcomes (2)
Energy intake (kJ, %)
The change in energy intake with and without protein-enriched ice cream.
Measured: four consecutive days while hospitalized
Evoked emotions
Check-all-that-apply (CATA) emotions word questionnaire
Measured: one day while hospitalized (first time the patients is offered a protein-enriched ice cream)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start14 Apr 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein IntakeStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- The participant will be their own control and will be randomised to start with control followed by intervention or the opposite order.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Tetens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Tetens, University of Copenhagen
- Investigators
- Inge Tetens, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764526
- Sponsor's protocol ID
- M238
- Status last verified
- Apr 2021
- First submitted
- 17 Feb 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Protein-enriched Ice Cream Increase Protein- and Energy Intake and at the Same Time Evoke Positive Emotions - a Feasibility Study Among Hospitalized Older Patients
- ClinicalTrials.gov ID
- NCT04764526
- Acronym / sponsor ID
- M238
- Conditions
- Protein Intake
- Keywords
- Protein-enrichment, Older hospitalized patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Inge TetensUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 21 Feb 2021 (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.
The primary aim is to investigate if protein-enriched ice cream has the feasibility to increase intake of protein without substituting other foods in hospitalized older patients and secondary, if the protein-enriched ice cream has the feasibility to increases the energy intake and evokes positive emotions in older hospitalized patients
Detailed description
Methods/Design:
This study is conducted as a four days non-blinded randomised cross-over feasibility study with 24 hospitalized older patients. The intervention is conducted at the hospital. The intervention is two days with two protein-enriched ice cream daily with the aim of increasing the intake of protein and energy. The patients are asked to answer a questionnaire concerning the emotions the protein enriched ice cream evoke.The patients will be randomised to receive the standard menu the first two days followed by two days with standard menu plus protein-enriched ice cream or in the opposite order. The randomisation will be done by using sealed envelopes.
Recruitment:
Only admitted patients will be a part of the trial. The ward staff will identify the patients there are eligible to the trial as close as possible to the day of admission. The ward staff will ask those patients who meet the inclusion criteria if they will participate in the trail. The patients receive oral and written information on the trial and those who agree to participate are asked to sign a statement of consent before participating. The patients can at any time withdraw their consent and leave the trial.
Sample size:
The sample size is estimated to 24 patients, who will be their own control.
Statistical analysis:
Non-parametric statistical tests, median and range will be performed due to the small sample size and skew distribution. The Wilcoxon signed rank test for paired data, and Fisher's exact test for categorical data. Evoked emotion are measured as the percentages of patients who choose a particular emotion term.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participant will be their own control and will be randomised to start with control followed by intervention or the opposite order.
| Arm | Type | Receives |
|---|---|---|
| Protein-enriched ice cream | Experimental | Other: Protein-enriched ice creamTwo protein-enriched ice cream daily (afternoon and evening) in two days in addition to the normal menu |
| Control | No intervention | –Standard menu in two days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- older admitted hospital patients age 65 or older, capable \& Danish speaking (able to read and understand the oral and written information and give written consent), able to eat, eat ice cream and expected to stay at the hospital least four days.
Key exclusion criteria (1 listed)
- terminally ill, tube feed, need of special diets, any medical indication suggesting that they should not participate or are on a weight reduction scheme
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 |
|---|---|---|
| Protein-enriched ice creamOffering two protein-enriched ice creams | Other | Protein-enriched ice cream |
Primary outcome
Protein intake (g, %)
Time frame: four consecutive days while hospitalized
The change in protein intake with and without protein-enriched ice cream.
2 secondary outcomes
Energy intake (kJ, %)
Time frame: four consecutive days while hospitalized
Evoked emotions
Time frame: one day while hospitalized (first time the patients is offered a protein-enriched ice cream)
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 17 Aug 2021.
- 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.
Inge Tetens, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-enriched ice cream in people with Protein Intake, run by Inge Tetens 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 1 inclusion and 1 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 17 Aug 2021. 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 (g, %) (time frame: four consecutive days while hospitalized). 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 17 Aug 2021.