Gastric Emptying Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03280706 -
Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial
|
N/A | |
Completed |
NCT03239821 -
Clinical Evaluation of the VIPUN Balloon Catheter 0.1
|
N/A | |
Completed |
NCT00896246 -
Scintigraphic Assessment Following Klean-Prep® or Moviprep®
|
Phase 1 | |
Completed |
NCT03694509 -
Gastric Emptying After Tea With Milk in Pregnancy.
|
N/A | |
Withdrawn |
NCT03376399 -
Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms
|
||
Completed |
NCT04092049 -
Lollipop on Gastric Emptying
|
N/A | |
Withdrawn |
NCT01008371 -
Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity.
|
N/A | |
Completed |
NCT00940849 -
Gastric Emptying and Gallbladder Motility Study
|
N/A | |
Completed |
NCT00980083 -
GLP-1 - Regulatory Mechanism of Postprandial Glycemia
|
Phase 1 | |
Completed |
NCT04571866 -
Gastric Emptying After Bread Consumption
|
N/A | |
Active, not recruiting |
NCT06195488 -
Gastric Ultrasound in Diabetic Patients
|
||
Recruiting |
NCT03636828 -
Gastric Emptying Time of a Rice-based Meal
|
||
Completed |
NCT04972357 -
Bariatric Procedures and Changes Gastric Passage
|
||
Completed |
NCT02587611 -
Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying
|
N/A | |
Completed |
NCT04263415 -
The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity
|
Phase 4 | |
Completed |
NCT05507801 -
Protein and Satiety in Older Adults (PROSAT)
|
N/A | |
Recruiting |
NCT04623450 -
Macronutrients and Satiety in Older and Younger Adults
|
N/A | |
Not yet recruiting |
NCT06391255 -
Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery
|
||
Recruiting |
NCT05977244 -
Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model
|
N/A | |
Completed |
NCT01133691 -
Examination of Gastric Emptying in Children
|
N/A |