Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000113055
Ethics application status
Approved
Date submitted
29/01/2010
Date registered
3/02/2010
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans
Scientific title
Evaluation of the acute effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans in healthy males versus overweight and obese males
Secondary ID [1] 1355 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 256709 0
Condition category
Condition code
Oral and Gastrointestinal 256866 256866 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gastric emptying and small intestinal transit will be measured using scintigraphy, which is the gold-standard for the measurement of gastric emptying, total, proximal and distal gastric volume and mouth-to-caecum transit. Subjects undergo a single test of 6 hours duration. Subjects will be asked to ingest a test drink comprising of 540 ml of Ensure (1 kcal/ml; 15% protein, 60% carbohydrate, 25 % fat) labelled with 20 MBq 99mTc-sulphur colloid. Gastric emptying will be measured by obtaining 1-minute anterior and 1-minute posterior images, with the subject standing, at regular time points during 5 hrs. Regions-of-interest will be drawn around the total stomach and gastric emptying curves (expressed as % retention over time) will be derived for the total stomach. To evaluate intragastric meal distribution, the total stomach region of interest will be divided into proximal and distal regions, with the proximal region corresponding to the fundus and proximal corpus and the distal region corresponding to the distal corpus and antrum. The mouth-to-caecum transit will be evaluated as the time from ingestion of the meal to the arrival of the head of the meal at the caecum. At the end of the study, subjects will be provided with a cold buffet styled lunch to consume freeely for upto 30 min.
Intervention code [1] 255940 0
Prevention
Comparator / control treatment
Lean Subjects will be compared to overweight and obese subjects
Control group
Active

Outcomes
Primary outcome [1] 257734 0
Intragastric meal distribution (ie the total stomach region and proximal and distal stomach regions). The mouth-to-caecum transit will be evaluated as the time from ingestion of the meal to the arrival of the head of the meal at the caecum. This was measured using scintigraphy
Timepoint [1] 257734 0
t = -15 min (baseline) and t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270 and 300 min
Secondary outcome [1] 263100 0
Hormone release - Cholecystokinin (CCK) and Peptide YY (PYY). Blood samples were drawn from subjects every 15 minutes until t=90, and then every 30 min from t = 90 - 300 min and then once more at t=330 after the buffet lunch. Radioimmunoassays were used to determine the concentration of these hormones in plasma.
Timepoint [1] 263100 0
t = -15 min (baseline) and t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330 min after consumption of drink'
Secondary outcome [2] 263101 0
Appetite and hunger - Using visual analogue scale questionnaires
Timepoint [2] 263101 0
t = -15 min (baseline) and t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330 min after consumption of drink'
Secondary outcome [3] 263102 0
Energy intake - At t = 300 min a cold buffet-style meal (t = 300 - 330 min). The meal will be weighted before and after consumption to for the assessment of energy intake using Foodwork
Timepoint [3] 263102 0
t = 300 min

Eligibility
Key inclusion criteria
Subjects will all be males between age 18 -56 years, with a body mass index (BMI) of 18 - 25 kg/m2 for lean, 25 - 30 kg/m2 for over-weight and between 30 -35 kg/m2 for obese. Lean subjects will be required to be unrestrained eaters. All other subjects would have to had consume less than 20g of alcohol per week, be non-smokers, free of gastrointestinal or chronic disease and not currently taking medication.
Minimum age
18 Years
Maximum age
56 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each subject will be questioned prior to the study to exclude: (1)significant gastrointestinal symptoms; disease or surgery (2)current use of medications which may alter gastrointestinal motor function or appetite (3)diabetes mellitus (fasting glucose >6.9 mmol/l and/or glycated haemoglobin >6.2 %) (4)epilepsy (5)cardiovascular or respiratory disease (6)any other significant illness as assessed by the investigator (7)allergy to local anaesthetic (8)intake of > 20 g alcohol on a daily basis (9)smokers (10)individuals with food intolerances, allergies or vegetarians

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited via newspaper advertisement or flyers which were posted in the local paper (Adelaide Advertiser), displayed within the University of Adelaide and the Royal Adelaide Hospital. Concealment allocation was not used in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2008
Actual
20/05/2008
Date of last participant enrolment
Anticipated
Actual
1/04/2011
Date of last data collection
Anticipated
Actual
27/04/2011
Sample size
Target
30
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256432 0
Self funded/Unfunded
Name [1] 256432 0
A/Prof Christine Feinle-Bisset
Country [1] 256432 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christine Feinle-Bisset
Address
Discipline of Medicine Level 6, Eleanor Harrald Building Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 255736 0
Individual
Name [1] 255736 0
A/Prof Karen Jones
Address [1] 255736 0
Discipline of Medicine Level 6, Eleanor Harrald Building Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country [1] 255736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258488 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258488 0
Ethics committee country [1] 258488 0
Australia
Date submitted for ethics approval [1] 258488 0
08/10/2007
Approval date [1] 258488 0
29/10/2007
Ethics approval number [1] 258488 0
071005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30786 0
Address 30786 0
Country 30786 0
Phone 30786 0
Fax 30786 0
Email 30786 0
Contact person for public queries
Name 14033 0
Radhika Seimon
Address 14033 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 14033 0
Australia
Phone 14033 0
+61 8 8222 5039
Fax 14033 0
+61 8 8223 3870
Email 14033 0
[email protected]
Contact person for scientific queries
Name 4961 0
Radhika Seimon
Address 4961 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 4961 0
Australia
Phone 4961 0
+61 8 8222 5039
Fax 4961 0
+61 8 8223 3870
Email 4961 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.