Does Adding Milk to Tea Delay Gastric Emptying?

NCT ID: NCT01809938

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-03-31

Brief 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.

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

Keywords

Gastrointestinal tract emptying; Pre-operative fasting; Ultrasound; Paracetamol Absorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Black Tea

Group Type: ACTIVE_COMPARATOR

Black tea

Intervention Type: OTHER

300ml of tea without milk

Tea with Milk

Group Type: ACTIVE_COMPARATOR

Tea with milk

Intervention Type: OTHER

250ml of black tea with 50ml of full fat milk

Interventions

Black tea

300ml of tea without milk

Intervention Type: OTHER

Tea with milk

250ml of black tea with 50ml of full fat milk

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy non-pregnant volunteers

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Sam Hillyard

Anaesthetic Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geraldine O'Sullivan

Role: PRINCIPAL_INVESTIGATOR

St Thomas' Hospital, Guy's & St Thomas' NHS Foundation Trust

Locations

St Thomas' Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 21712716 (View on PubMed)

Wong 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.

Reference Type: BACKGROUND

PMID: 12170052 (View on PubMed)

Darwiche 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.

Reference Type: BACKGROUND

PMID: 10511299 (View on PubMed)

Other Identifiers

STH01

Identifier Type: -

Identifier Source: org_study_id