Trial Outcomes & Findings for Does Adding Milk to Tea Delay Gastric Emptying? (NCT NCT01809938)

Last Updated: 2013-12-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

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

Results posted on

2013-12-18

Participant Flow

Recruitment took place from november 2011 until january 2012 at St Thomas' Hospital, London

Participant milestones

Participant milestones
Measure	Black Tea First, Then Tea With Milk Effects on gastric emptying of Black tea (300ml of tea without milk) were assessed then after a period of not less than 24 hours the effects of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed	Tea With Milk First Then Black Tea Effects on gastric emptying of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed then after a period of not less than 24 hours the effects of Black tea (300ml of tea without milk) were assessed.
First Intervention (170 Minutes) STARTED	5	5
First Intervention (170 Minutes) COMPLETED	5	5
First Intervention (170 Minutes) NOT COMPLETED	0	0
Washout (Not Less Than 24 Hours) STARTED	5	5
Washout (Not Less Than 24 Hours) COMPLETED	5	5
Washout (Not Less Than 24 Hours) NOT COMPLETED	0	0
Second Intervention (170 Minutes) STARTED	5	5
Second Intervention (170 Minutes) COMPLETED	5	5
Second Intervention (170 Minutes) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Adding Milk to Tea Delay Gastric Emptying?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=10 Participants Includes all participants in this crossover trial
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United Kingdom	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Black Tea n=10 Participants Black tea : 300ml of tea without milk	Tea With Milk n=10 Participants Tea with milk : 250ml of black tea with 50ml of full fat milk
Tmax	38 minutes Standard Deviation 17.6	30 minutes Standard Deviation 23.9

SECONDARY outcome

Timeframe: 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.

Population: It was difficult to visualise under ultrasound the gastric antrum in one patient after they drank both black tea and tea with milk, so they were exlcuded from final analysis of the US data only.

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 - \[(CSAmax - CSAbaseline)/2\]

Outcome measures

Outcome measures
Measure	Black Tea n=9 Participants Black tea : 300ml of tea without milk	Tea With Milk n=9 Participants Tea with milk : 250ml of black tea with 50ml of full fat milk
T½	22.7 minutes Interval 12.7 to 40.9	23.6 minutes Interval 13.5 to 41.0

Adverse Events

Entire Study Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sam Hillyard

GuysThomasNHSTrust / Rockingham General Hospital

Phone: +61424055820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place