Gastric EmptyingGETEAMNCT01809938
Does Adding Milk to Tea Delay Gastric Emptying?
A study testing Black tea and Tea with milk in people with Gastric Emptying, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee, the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study is to demonstrate whether there is really a delay in gastric emptying time associated with the inclusion of milk in a cup of tea. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Black tea and Tea with milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-pregnant volunteers
Who cannot join
- medical conditions with a predisposition to delayed gastric emptying (e.g. diabetes or gastric disease)
- ingestion of paracetamol within the previous 24 hours
- ingestion of solids or non-clear liquids in the previous six hours
- ingestion of clear liquids in the previous two hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Emptying of Tea With Milk, Compared With Tea Without Milk. Does Milk Delay Gastric Emptying?
Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee, the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study is to demonstrate whether there is really a delay in gastric emptying time associated with the inclusion of milk in a cup of tea.
Read the detailed description
This was a randomised controlled crossover study conducted in ten healthy volunteers. The paracetamol absorption technique and real-time ultrasound measurement of the cross-sectional area (CSA) of the gastric antrum were used to assess gastric emptying following ingestion of 300ml of black tea or 300ml of tea with milk (250ml black tea plus 50ml of full fat milk)
Each participant took part in both arms of the trial, drinking black tea and tea with milk, the order of which was determined by a computerised random number generator and concealed from the investigators by opaque brown paper envelopes.
In each arm of the study the procedure was as follows. The subject sat in a semi-reclined position at a 45 angle, a 16g intravenous cannula was sited in an upper limb and baseline blood samples taken. The initial cross-sectional area of the gastric antrum was then measured by ultrasound.
The investigating anaesthetist then left the room, the subject opened their randomisation envelope and drank, as directed, either 300ml of black tea or 300ml of tea with milk (250ml black tea plus 50ml of full fat milk) over 3 minutes, followed by 1.5 g of dispersible paracetamol dissolved in 30ml of water.
Blood samples were taken every 10 minutes for the first hour, then every 30 minutes until 150 minutes had elapsed. Paracetamol concentrations in each sample were measured using an enzymatic assay. Time to peak concentration (tmax) was thus determined.
The CSA of the gastric antrum was measured by ultrasound in real-time (RUS) at baseline, every ten minutes for 60 minutes and then at 30-minute intervals for 150 minutes. Antral CSA was plotted against time and gastric emptying expressed as half-time to gastric emptying (T½). This was defined as the time from baseline to the time the gastric antrum returns to half the maximal value.
The primary outcome was tmax. Previous studies have shown mean or median tmax values for paracetamol to vary from 25 to 60 minutes following ingestion of clear fluids, with standard deviation up to 38 minutes. In this study we considered that a delay of gastric emptying of under 60 minutes would not be clinically important; and that we would be able to declare that the two regimes were equivalent if the (two sided) 95% confidence interval for the mean difference in tmax, between black tea and tea with milk included only times less than 60 minutes. Using these assumptions and taking (pessimistically) a correlation between repeated measurements of 0.0, power analysis determined nine participants would be required (with 90% power) to show equivalence.
A 95% confidence interval for the mean difference in tmax that lay entirely within 60 minutes of no effect would confirm the hypothesis that tea with milk was clinically equivalent to black tea.
- Conditions
- Gastric Emptying
- Being tested
- Black tea, Tea with milk
- Keywords
- Gastrointestinal tract emptying, Pre-operative fasting, Ultrasound, Paracetamol Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black teaOther
300ml of tea without milk
Tea with milkOther
250ml of black tea with 50ml of full fat milk
| Study group | Role | What they receive |
|---|---|---|
| Black Tea | Active comparator | Not described Receives: Other: Black tea |
| Tea with Milk | Active comparator | Not described Receives: Other: Tea with milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.
Measured: Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours
Secondary outcomes (1)
T½
T½ = time from baseline to the time the cross-sectional surface area (CSA) of the gastric antrum, measured using realtime ultrasound, returned to half the maximal value (CSA½max ). CSA ½ max calculated as below:
CSA½max = CSAmax - [(CSAmax - CSAbaseline)/2]
Measured: Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Hillyard, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Geraldine O'Sullivan, Principal investigator, St Thomas' Hospital, Guy's & St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809938
- Sponsor's protocol ID
- STH01
- Acronym
- GETEAM
- Status last verified
- Nov 2013
- First submitted
- 7 Mar 2013
- Last updated
- 18 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. doi: 10.1097/00000542-200206000-00019.
PubMed 12170052Darwiche G, Almer LO, Bjorgell O, Cederholm C, Nilsson P. Measurement of gastric emptying by standardized real-time ultrasonography in healthy subjects and diabetic patients. J Ultrasound Med. 1999 Oct;18(10):673-82. doi: 10.7863/jum.1999.18.10.673.
PubMed 10511299
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying of Tea With Milk, Compared With Tea Without Milk. Does Milk Delay Gastric Emptying?
- ClinicalTrials.gov ID
- NCT01809938
- Acronym / sponsor ID
- GETEAM / STH01
- Conditions
- Gastric Emptying
- Keywords
- Gastrointestinal tract emptying, Pre-operative fasting, Ultrasound, Paracetamol Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Posted 30 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee, the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study is to demonstrate whether there is really a delay in gastric emptying time associated with the inclusion of milk in a cup of tea.
Detailed description
This was a randomised controlled crossover study conducted in ten healthy volunteers. The paracetamol absorption technique and real-time ultrasound measurement of the cross-sectional area (CSA) of the gastric antrum were used to assess gastric emptying following ingestion of 300ml of black tea or 300ml of tea with milk (250ml black tea plus 50ml of full fat milk)
Each participant took part in both arms of the trial, drinking black tea and tea with milk, the order of which was determined by a computerised random number generator and concealed from the investigators by opaque brown paper envelopes.
In each arm of the study the procedure was as follows. The subject sat in a semi-reclined position at a 45 angle, a 16g intravenous cannula was sited in an upper limb and baseline blood samples taken. The initial cross-sectional area of the gastric antrum was then measured by ultrasound.
The investigating anaesthetist then left the room, the subject opened their randomisation envelope and drank, as directed, either 300ml of black tea or 300ml of tea with milk (250ml black tea plus 50ml of full fat milk) over 3 minutes, followed by 1.5 g of dispersible paracetamol dissolved in 30ml of water.
Blood samples were taken every 10 minutes for the first hour, then every 30 minutes until 150 minutes had elapsed. Paracetamol concentrations in each sample were measured using an enzymatic assay. Time to peak concentration (tmax) was thus determined.
The CSA of the gastric antrum was measured by ultrasound in real-time (RUS) at baseline, every ten minutes for 60 minutes and then at 30-minute intervals for 150 minutes. Antral CSA was plotted against time and gastric emptying expressed as half-time to gastric emptying (T½). This was defined as the time from baseline to the time the gastric antrum returns to half the maximal value.
The primary outcome was tmax. Previous studies have shown mean or median tmax values for paracetamol to vary from 25 to 60 minutes following ingestion of clear fluids, with standard deviation up to 38 minutes. In this study we considered that a delay of gastric emptying of under 60 minutes would not be clinically important; and that we would be able to declare that the two regimes were equivalent if the (two sided) 95% confidence interval for the mean difference in tmax, between black tea and tea with milk included only times less than 60 minutes. Using these assumptions and taking (pessimistically) a correlation between repeated measurements of 0.0, power analysis determined nine participants would be required (with 90% power) to show equivalence.
A 95% confidence interval for the mean difference in tmax that lay entirely within 60 minutes of no effect would confirm the hypothesis that tea with milk was clinically equivalent to black tea.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black Tea | Active comparator | Other: Black tea |
| Tea with Milk | Active comparator | Other: Tea with milk |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy non-pregnant volunteers
Key exclusion criteria (4 listed)
- medical conditions with a predisposition to delayed gastric emptying (e.g. diabetes or gastric disease)
- ingestion of paracetamol within the previous 24 hours
- ingestion of solids or non-clear liquids in the previous six hours
- ingestion of clear liquids in the previous two hours.
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 |
|---|---|---|
| Black tea300ml of tea without milk | Other | Black Tea |
| Tea with milk250ml of black tea with 50ml of full fat milk | Other | Tea with Milk |
Primary outcome
Tmax
Time frame: Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours
tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.
1 secondary outcome
T½
Time frame: Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Background: PubMed 12170052Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. doi: 10.1097/00000542-200206000-00019.
- Background: PubMed 10511299Darwiche G, Almer LO, Bjorgell O, Cederholm C, Nilsson P. Measurement of gastric emptying by standardized real-time ultrasonography in healthy subjects and diabetic patients. J Ultrasound Med. 1999 Oct;18(10):673-82. doi: 10.7863/jum.1999.18.10.673.
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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.
Geraldine O'Sullivan principal investigator
St Thomas' Hospital, Guy's & St Thomas' NHS Foundation 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 Black tea and Tea with milk in people with Gastric Emptying, run by Guy's and St Thomas' NHS Foundation 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 1 inclusion and 4 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 18 Dec 2013. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tmax (time frame: Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809938, which also lists 3 linked publications.
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 18 Dec 2013.