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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 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.
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.
Secondary ID [1] 252189 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257723 0
Condition category
Condition code
Diet and Nutrition 257894 257894 0 0
Obesity
Oral and Gastrointestinal 257895 257895 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256781 0
Other interventions
Comparator / control treatment
Placebo: A 500ml 0kJ water preload.
Control group
Placebo

Outcomes
Primary outcome [1] 258759 0
Antral area, assessed using 2D Ultrasound.
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.
Primary outcome [2] 258760 0
Macronutrient and total energy intake at the buffet meal will be analysed using the FoodWorks software program.
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
Secondary outcome [1] 264817 0
Appetite perceptions using a Visual Analogue Scale (VAS) (satiety, hunger, fullness, thirst, desire to eat, prospective consumption).
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.

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).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was generated using Microsoft Office Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2010
Actual
20/07/2010
Date of last participant enrolment
Anticipated
Actual
1/05/2012
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
40
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 3029 0
5000
Recruitment postcode(s) [2] 3030 0
5043
Recruitment postcode(s) [3] 3031 0
5061
Recruitment postcode(s) [4] 3032 0
5038
Recruitment postcode(s) [5] 3033 0
5037
Recruitment postcode(s) [6] 3034 0
5045
Recruitment postcode(s) [7] 3035 0
5008

Funding & Sponsors
Funding source category [1] 257271 0
Government body
Name [1] 257271 0
National Health and Medical Research Council Grant
Country [1] 257271 0
Australia
Primary sponsor type
Individual
Name
Christine Feinle-Bisset
Address
Level 6, Eleanor Harrald Building
Frome Rd
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256517 0
Individual
Name [1] 256517 0
Tanya Little
Address [1] 256517 0
Level 6, Eleanor Harrald Building
Frome Rd
Adelaide SA 5000
Country [1] 256517 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259299 0
Royal Adelaide Hospital Research Ethics Comittee
Ethics committee address [1] 259299 0
Ethics committee country [1] 259299 0
Australia
Date submitted for ethics approval [1] 259299 0
Approval date [1] 259299 0
28/06/2010
Ethics approval number [1] 259299 0
100606

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

Contacts
Principal investigator
Name 31379 0
Prof Christine Feinle-Bisset
Address 31379 0
AHMS building, Cnr North Terrace and George Street
Country 31379 0
Australia
Phone 31379 0
+61 8313 6053
Fax 31379 0
Email 31379 0
[email protected]
Contact person for public queries
Name 14626 0
Dr Tanya Little
Address 14626 0
Level 6, Eleanor Harrald Bulding
Frome Rd
Adelaide SA 5000
Country 14626 0
Australia
Phone 14626 0
+61 8 8222 0724
Fax 14626 0
Email 14626 0
[email protected]
Contact person for scientific queries
Name 5554 0
Dr Tanya Little
Address 5554 0
Level 6, Eleanor Harrald Bulding
Frome Rd
Adelaide SA 5000
Country 5554 0
Australia
Phone 5554 0
+61 8 8222 0724
Fax 5554 0
Email 5554 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.