Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12610000568011
Ethics application status
Approved
Date submitted
12/07/2010
Date registered
13/07/2010
Date last updated
28/05/2021
Date data sharing statement initially provided
28/05/2021
Date results information initially provided
28/05/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of timing of buffet-meal presentation on energy intake following a nutrient preload in humans: relationships with gastrointestinal functions.
Query!
Scientific title
The effects of timing of buffet-meal presentation on energy intake following a nutrient preload in lean and obese humans: relationships with gastric emptying, antral area and gastrointestinal hormone release.
Query!
Secondary ID [1]
252189
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Obesity
257723
0
Query!
Condition category
Condition code
Diet and Nutrition
257894
257894
0
0
Query!
Obesity
Query!
Oral and Gastrointestinal
257895
257895
0
0
Query!
Normal oral and gastrointestinal development and function
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Three 500ml nutrient preloads (Ensure; 2240kJ (2.24MJ)), taken at t = 180 (Study Condition EI180), t = 90 (Study Condition EI90), t = 30 (Study Condition EI30), and one 500ml water preload (control condition). The same nutrient preload will be taken in all study conditions, excluding the water control condition.
Appetite sensation questionnaires in the form of a Visual Analogue Scale (VAS), blood samples, 2D Ultrasound scan to assess antral area.
A buffet meal will be presented 30, 90 or 180 minutes after the nutrient preload ingestion, and 180 minutes after the water preload ingestion, and the participant has 30 minutes to eat until comfortably full. The buffet meal consists of 300ml orange juice, 600ml water, 375ml iced coffee, 4 slices white bread, 4 slices brown bread, 100g deli leg ham, 100g virginian chicken, 4 slices cheese, 100g tomato, 100g cucumber, 100g lettuce, 2 portions mayonnaise, 2 portions margarine, 1 medium apple, 1 medium banana, 200g chocolate custard, 150g fruit salad, and 200g strawberry yoghurt.
Each volunteer will recieve one nutrient preload on each of 3 study days, and the water preload on the remaining study day. Each study visit will be separated by approximately one week, and will last approximately 2-4 hours.
Query!
Intervention code [1]
256781
0
Other interventions
Query!
Comparator / control treatment
Placebo: A 500ml 0kJ water preload.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
258759
0
Antral area, assessed using 2D Ultrasound.
Query!
Assessment method [1]
258759
0
Query!
Timepoint [1]
258759
0
On each study visit, a 2D Ultrasound scan will be performed to assess antral area at baseline (t = -10). In all conditions, antral area will be assessed every 5 min after preload ingestion, until t = 180 min.
Query!
Primary outcome [2]
258760
0
Macronutrient and total energy intake at the buffet meal will be analysed using the FoodWorks software program.
Query!
Assessment method [2]
258760
0
Query!
Timepoint [2]
258760
0
Buffet meal will be presented at t = 180 min, and the subject will be allowed to freely consume food until comfortably full for 30 min (until t = 210
Query!
Secondary outcome [1]
264817
0
Appetite perceptions using a Visual Analogue Scale (VAS) (satiety, hunger, fullness, thirst, desire to eat, prospective consumption).
Query!
Assessment method [1]
264817
0
Query!
Timepoint [1]
264817
0
On all study days, at t = -10 a baseline blood sample and VAS will be obtained.
Study condition EI180 and Control: Blood sample and VAS obtained at 10 min intervals from t = 0-30, at 15 min intervals from t = 30-90, and then at 30 min intervals until presentation of buffet meal at t = 180.
Study condition EI90: Blood sample and VAS obatined at t = 0, at 10 min intervals from t = 90-120, and at then 15 min intervals until presentation of buffet meal at t = 180.
Study condition EI30: Blood sample and VAS obtained at t = 0, then at 10 min intervals from t = 150 until presentation of buffet meal at t = 180.
Query!
Eligibility
Key inclusion criteria
Non-obese with a Body Mass Index (BMI) of 19-25kg/m2) and obese with a BMI >30kg/m2 and waist circumference > 102cm for males and >97cm for females.
Female subjects will be included on the basis that they are using an appropriate contraceptive method (i.e. oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device (IUD), Norplant method).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Significant gastrointestinal symptoms, disease or surgery. Current use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal (GI) function, body weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), metclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St John's Wort etc). Significant illness as assessed by the investigator.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will undergo a screening visit at which they will complete questionnaires to assess their suitability for the study, and also provide informed, written, consent. At this screening visit, we will collect a fasting blood sample to assess haemoglobin (Hb) and iron levels. Study dates are established. Eligible volunteers are randomised into a treatment for each study visit, using a randomisation table created in an excel spreadsheet. Allocation is not concealed.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was generated using Microsoft Office Excel.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
20/07/2010
Query!
Actual
20/07/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
1/05/2012
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2012
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
16
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment postcode(s) [1]
3029
0
5000
Query!
Recruitment postcode(s) [2]
3030
0
5043
Query!
Recruitment postcode(s) [3]
3031
0
5061
Query!
Recruitment postcode(s) [4]
3032
0
5038
Query!
Recruitment postcode(s) [5]
3033
0
5037
Query!
Recruitment postcode(s) [6]
3034
0
5045
Query!
Recruitment postcode(s) [7]
3035
0
5008
Query!
Funding & Sponsors
Funding source category [1]
257271
0
Government body
Query!
Name [1]
257271
0
National Health and Medical Research Council Grant
Query!
Address [1]
257271
0
Level 1, 16 Marcus St
Canberra ACT 2601
Query!
Country [1]
257271
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Christine Feinle-Bisset
Query!
Address
Level 6, Eleanor Harrald Building
Frome Rd
Adelaide SA 5000
Query!
Country
Australia
Query!
Secondary sponsor category [1]
256517
0
Individual
Query!
Name [1]
256517
0
Tanya Little
Query!
Address [1]
256517
0
Level 6, Eleanor Harrald Building
Frome Rd
Adelaide SA 5000
Query!
Country [1]
256517
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
259299
0
Royal Adelaide Hospital Research Ethics Comittee
Query!
Ethics committee address [1]
259299
0
Level 3, Hanson Institute
North Tce
Adelaide SA 5000
Query!
Ethics committee country [1]
259299
0
Australia
Query!
Date submitted for ethics approval [1]
259299
0
Query!
Approval date [1]
259299
0
28/06/2010
Query!
Ethics approval number [1]
259299
0
100606
Query!
Summary
Brief summary
This study has been designed to investigate how energy intake at a buffet meal will be affected when the meal is presented at different times following a nutrient preload, and and how it is related to antral area, gut hormones and appetite sensations.
Volunteers are required to visit the department on 4 occasions approximately 1 week apart. They will be required to ingest either a water or liquid nutrient preload, and 2D Ultrasound scans, blood samples and VAS will be taken at various timepoints depending on the treatment. A buffet meal will be presented 30, 90 or 180 min after the preload, and will be consumed over 30 min until the volunteer is comfortable full.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31379
0
Prof Christine Feinle-Bisset
Query!
Address
31379
0
AHMS building, Cnr North Terrace and George Street
Query!
Country
31379
0
Australia
Query!
Phone
31379
0
+61 8313 6053
Query!
Fax
31379
0
Query!
Email
31379
0
[email protected]
Query!
Contact person for public queries
Name
14626
0
Dr Dr Tanya Little
Query!
Address
14626
0
Level 6, Eleanor Harrald Bulding
Frome Rd
Adelaide SA 5000
Query!
Country
14626
0
Australia
Query!
Phone
14626
0
+61 8 8222 0724
Query!
Fax
14626
0
Query!
Email
14626
0
[email protected]
Query!
Contact person for scientific queries
Name
5554
0
Dr Dr Tanya Little
Query!
Address
5554
0
Level 6, Eleanor Harrald Bulding
Frome Rd
Adelaide SA 5000
Query!
Country
5554
0
Australia
Query!
Phone
5554
0
+61 8 8222 0724
Query!
Fax
5554
0
Query!
Email
5554
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
The trial was completed in 2012, and access to the IPD is not available to me as the registration holder.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Effects of varying the inter-meal interval on rela...
[
More Details
]
Documents added automatically
No additional documents have been identified.
Download to PDF