Post Operative NutritionTASTENCT02154841
Changes in Taste Perception and Preference in the Peri-operative Patient
A study testing Questionnaire, taste test, visual food test in people with Post Operative Nutrition, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
It is well known that patients who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis, reduces surgical site infection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Nutrition
- What is being tested?
- Questionnaire, taste test, visual food test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo the following laparoscopic procedures
- anterior resection
- right/Left hemicolectomy
- sigmoid colectomy
- abdominal-perineal resection
- stoma formation
Who cannot join
- The participant may not enter the study if:
- patients under 18 years old
- if they report any protracted change in taste over the 6 months prior to surgery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this study
It is well known that patients who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis, reduces surgical site infection and length of hospital stay. The 'Enhanced recovery programme', ERP, includes early post-operative nutrition as one of its key goals, however there is no guidance on the type of food that should be offered to patients in this programme. Anecdotally, many patients and healthcare professionals believe that there are differences in how food tastes to early post-operative patients. If there are changes in taste following surgery this will affect the food choices that patients make in the early post-operative period. No studies have addressed this question to date. In this study we hope to describe this affect and consider the significance of any changes on the background of current hospital food options.
We hypothesise that food preference and tastes and desires are altered in the early post operative period and this affects what patients eat at this critical time.
Read the detailed description
Nutrition is a vital component of good health and recovery from illness. It is particularly clear that patients with chronic diseases and those who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Over the last decade, surgical practices have evolved to encourage patients to resume early enteral feeding in order to avoid post-operative under-nutrition. Inadequate nutrition has previously been shown to be associated with prolongation of the acute phase response and increased incidence of septic morbidity. More recently clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis. Further to this there is also evidence of benefit to patients by reduction of surgical site infections and other complications. Along with the cost saving of a lower complication rate there are financial benefits from reduced mean length of hospital stay.
Over the last 5 years the importance of non-surgical factors in patient recovery or the development of complications has been highlighted. This has resulted in the development and near universal adoption of the 'Enhanced recovery programme (ERP)'. The ERP is a multidisciplinary initiative aiming to improve the patients' journey by:
- Optimizing pre-operative health status
- Reducing postoperative complications and the surgical and physiological stress responses by changing traditional surgical methods
- Early mobility
- Early feeding Post-operative nutrition is a key component to the ERP approach, however, many units that run ERP have reported that encouraging early post operative patients to increase their oral intake is difficult. Our own experience is that dysgeusia (distortion of the sense of taste) is common in the postoperative group.
At present there are no publications in the literature on how best to support the delivery of nutrition to this important group and there is no literature on food preferences in patients who have recently undergone surgery. To date there has not been any research on the subject of peri-operative taste changes outside of surgical fields that directly affect the sensory system of taste (Ear, nose and throat surgery). Although there have been some descriptive studies on calorie intake in the peri-operative period no studies have been performed to confirm the existence of post-operative taste changes or to describe them.
In order to optimise recovery from surgery and as part of the ERP programme, patients should be provided with food choices that encourage greater intake. It is known that optimising early post-operative nutrition will contribute to early discharge and uncomplicated recovery and have knock on benefits for inpatient costs. In order to provide this it is vital that we consider the issue of presumed dysgeusia and its affect on food choices. In order to begin this process the following study is proposed. It is hoped that the results of this study will allow re-evaluation of hospital menus to optimise post-operative nutrition.
- Conditions
- Post Operative Nutrition
- Being tested
- Questionnaire, taste test, visual food test
- Keywords
- Postoperative, nutrition, taste, perception, preference, choice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, taste test, visual food testBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire, taste test, visual food test | Experimental | The participants will complete a questionnaire that asks them about their taste preferences. They will also will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred. Receives: Behavioral: Questionnaire, taste test, visual food test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe taste appreciation and detection in the pre and post-operative Assess taste changes in the peri-operative patient
Patients that agree to participate will complete a questionnaire that asks them about their taste preferences. Recruits will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred.
Measured: 3 days post operation
Secondary outcomes (2)
Assess taste preferences in the peri-operative patient
Patients that agree to participate will complete a questionnaire that asks them about their taste preferences. Recruits will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred.
Measured: 3 days post operation
Patients choice of meal from a selection of photographs of food
Patients that agree to participate will complete a questionnaire that asks them about their taste preferences. Recruits will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred.
Measured: 3 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative NutritionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Lewis, M.B., Ch.B., M.D., Study director, University Hospital Plymouth NHS TrustSophie-Anne Welchman, B.Sc.(Hons), M.B.B.S., Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154841
- Sponsor's protocol ID
- 11/P/009
- Other IDs
- 10/H0203/74
- Acronym
- TASTE
- Status last verified
- May 2014
- First submitted
- 30 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Taste Perception and Preference in the Peri-operative Patient
- ClinicalTrials.gov ID
- NCT02154841
- Acronym / sponsor ID
- TASTE / 11/P/009
- Conditions
- Post Operative Nutrition
- Keywords
- Postoperative, nutrition, taste, perception, preference, choice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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.
It is well known that patients who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis, reduces surgical site infection and length of hospital stay. The 'Enhanced recovery programme', ERP, includes early post-operative nutrition as one of its key goals, however there is no guidance on the type of food that should be offered to patients in this programme. Anecdotally, many patients and healthcare professionals believe that there are differences in how food tastes to early post-operative patients. If there are changes in taste following surgery this will affect the food choices that patients make in the early post-operative period. No studies have addressed this question to date. In this study we hope to describe this affect and consider the significance of any changes on the background of current hospital food options.
We hypothesise that food preference and tastes and desires are altered in the early post operative period and this affects what patients eat at this critical time.
Detailed description
Nutrition is a vital component of good health and recovery from illness. It is particularly clear that patients with chronic diseases and those who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Over the last decade, surgical practices have evolved to encourage patients to resume early enteral feeding in order to avoid post-operative under-nutrition. Inadequate nutrition has previously been shown to be associated with prolongation of the acute phase response and increased incidence of septic morbidity. More recently clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis. Further to this there is also evidence of benefit to patients by reduction of surgical site infections and other complications. Along with the cost saving of a lower complication rate there are financial benefits from reduced mean length of hospital stay.
Over the last 5 years the importance of non-surgical factors in patient recovery or the development of complications has been highlighted. This has resulted in the development and near universal adoption of the 'Enhanced recovery programme (ERP)'. The ERP is a multidisciplinary initiative aiming to improve the patients' journey by:
- Optimizing pre-operative health status
- Reducing postoperative complications and the surgical and physiological stress responses by changing traditional surgical methods
- Early mobility
- Early feeding Post-operative nutrition is a key component to the ERP approach, however, many units that run ERP have reported that encouraging early post operative patients to increase their oral intake is difficult. Our own experience is that dysgeusia (distortion of the sense of taste) is common in the postoperative group.
At present there are no publications in the literature on how best to support the delivery of nutrition to this important group and there is no literature on food preferences in patients who have recently undergone surgery. To date there has not been any research on the subject of peri-operative taste changes outside of surgical fields that directly affect the sensory system of taste (Ear, nose and throat surgery). Although there have been some descriptive studies on calorie intake in the peri-operative period no studies have been performed to confirm the existence of post-operative taste changes or to describe them.
In order to optimise recovery from surgery and as part of the ERP programme, patients should be provided with food choices that encourage greater intake. It is known that optimising early post-operative nutrition will contribute to early discharge and uncomplicated recovery and have knock on benefits for inpatient costs. In order to provide this it is vital that we consider the issue of presumed dysgeusia and its affect on food choices. In order to begin this process the following study is proposed. It is hoped that the results of this study will allow re-evaluation of hospital menus to optimise post-operative nutrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire, taste test, visual food test | Experimental | Behavioral: Questionnaire, taste test, visual food testThe participants will complete a questionnaire that asks them about their taste preferences. They will also will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who undergo the following laparoscopic procedures
- anterior resection
- right/Left hemicolectomy
- sigmoid colectomy
- abdominal-perineal resection
Key exclusion criteria (3 listed)
- patients under 18 years old
- if they report any protracted change in taste over the 6 months prior to surgery
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 |
|---|---|---|
| Questionnaire, taste test, visual food test | Behavioural | Questionnaire, taste test, visual food test |
Primary outcome
To describe taste appreciation and detection in the pre and post-operative Assess taste changes in the peri-operative patient
Time frame: 3 days post operation
Patients that agree to participate will complete a questionnaire that asks them about their taste preferences. Recruits will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred.
2 secondary outcomes
Assess taste preferences in the peri-operative patient
Time frame: 3 days post operation
Patients choice of meal from a selection of photographs of food
Time frame: 3 days post operation
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 Jun 2014.
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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.
Stephen Lewis, M.B., Ch.B., M.D. study director
University Hospital Plymouth NHS Trust
Sophie-Anne Welchman, B.Sc.(Hons), M.B.B.S. principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, taste test, visual food test in people with Post Operative Nutrition, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 3 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 Jun 2014. 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 United Kingdom. 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?
To describe taste appreciation and detection in the pre and post-operative Assess taste changes in the peri-operative patient (time frame: 3 days post operation). 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 Jun 2014.