Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000055707
Ethics application status
Approved
Date submitted
10/01/2013
Date registered
16/01/2013
Date last updated
16/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The association between oral fatty acid sensitivity and acute excess energy consumption in healthy weight and obese subjects
Scientific title
Investigating the association between oral fatty acid sensitivity and acute excess energy consumption in healthy weight and obese subjects.
Secondary ID [1] 281740 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 288047 0
Condition category
Condition code
Diet and Nutrition 288422 288422 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was designed to assess if there was an association between oral fatty acid (FA) taste sensitivity and perceived satiety following consumption of a high fat meal.
Subjects were classified as hypersensitive or hyposensitive by the concentration threshold at which they identified C18:1 as an odd sample of three, using two control solutions.

In sessions 1 and 6 subjects were assessed for oral fatty acid taste sensitivity and classified as either hypersensitive or hyposensitive to FA. Oleic acid (C18:1) was used for FA sensitivity tests as it is most commonly used in the food system and liquid at room temperature, therefore practical for usage.
Subjects were asked to identify a sample containing C18:1 using triangle methodology. C18:1 was added in varying concentrations (0.02mM-12mM) to long life non-fat milk and each C18:1 sample was presented to subjects with 2 control samples. C18:1 was stored under N2 below 4 degrees Celsius. Viscosity and textural variations between control milk and C18:1 samples were minimised by addition of 5% (w/v) gum acacia and liquid paraffin. To prevent oxidation of C18:1 within samples, 0.01% ETDA was added. Samples were homogenized for approximately 30 sec/100ml at 7000rpm and were prepared fresh on the day of testing.
Samples were presented to subjects at room temperature and detection thresholds determined using ascending concentrations of C18:1samples. If correctly identified subjects were presented with another set of samples where C18:1 remained at the same concentration. If incorrect, subjects were presented with three more samples where the C18:1 concentration was increased to the next concentration. This procedure continued until the subject identified the C18:1 sample at the same concentration 3 consecutive times. The concentration at which this occurred was defined as the subject’s oral detection threshold for C18:1. Hypersensitivity was defined by correctly identifying the odd C18:1 sample three times consecutively at less than 3.8mM while hyposensitive subjects required higher concentrations.
To prevent confounding from olfactory cues, subjects wore nose clips. To minimize possible visual cues generated by the addition of C18:1, subjects were tested under red light. Subjects were tested in duplicate on both testing days to ensure consistency.

During session 1, height and weight were also measured. Prior to any measurements being taken subjects were required to remove shoes, heavy clothing and items from their pockets. Body weight (kg) was measured using scales (accuracy +/- 0.1kg) and height (m) was measured using a stadiometer. Height and weight were used to calculate each subject’s BMI, using the following equation; weight (kg)/height (m^2). Subjects were categorised according to the standard definition values for BMI; healthy 18.5-25 kg/m^2, overweight 25-30 kg/m^2, obese >30 kg/m^2.

During the first session subjects were also asked to complete a Deakin University FFQ to indicate their usual pattern of food intake and habitual fat consumption for the month prior to participation in the study. This questionnaire was developed based on the ABS National Health Survey 1995 and consisted of questions such as “What is your average consumption of flavoured milk drinks per month?”
Subject's also completed a 4-day diet diary to indicate dietary habits (3 weekday and 1 weekend day). Subjects were asked to record all food and drink consumed within their normal eating pattern. Subjects were asked, if possible to weigh foods or provide measurement details and to specify details of brand, recipes, addition of fat and the method of cooking (E.g. frying or grilling). Diet diaries were analysed using FoodWorks. Mean energy intake (kJ), amount (g) and percentage from dietary fats, protein and carbohydrate was calculated and the type of fat used was also noted.

During sessions 2-5 subjects attended the laboratory where they consumed 4 different breakfasts which varied in macronutrient contribution to energy followed by a buffet style lunch. Participants attended these 4 meal sessions over the space of 2 weeks, attending at least one per week. There was no minimum wash-out period required between meal sessions, with participants able to attend a subsequent session the following day. The macronutrient ratios of the breakfast meals were as follows; Breakfast 1: High carbohydrate, 50% carbohydrate, 25% fat, 25% protein, Breakfast 2: High fat, 50% fat, 25% carbohydrate, 25% protein, Breakfast 3: High protein, 50% protein, 25% fat, 25% carbohydrate, Breakfast 4: Balanced macronutrient, 33% carbohydrate, 33% fat, 33% protein. An egg based breakfast frittata was chosen as this was easily manipulated to vary macronutrient ratios. Dietary fibre was balanced across all breakfast meals (g) as this is a known confounding satiety factor.The liquid mass of each breakfast was calculated and to compensate for any mass variation breakfasts were equated with water.
Breakfast was served in the laboratory at 9:00am in a social setting. Subjects were required to finish the entire serving and asked to return in the afternoon (12:00pm) to consume a buffet style lunch Lunch was provided in excess (8621kJ) and foods included chips, homemade potato and leek soup, pasta bake, salad with Italian salad dressing, pastries, grapes and chocolate bars. Subjects were asked to eat until comfortably full and the amount eaten was measured by weight (g) using kitchen scales and energy (kJ) as an indication of satiety. No food was consumed between breakfast and lunch (including tea or coffee) to ensure an accurate measure of satiety. Subjects were able to consume water up to an hour prior to lunch.
The evening prior to the meal testing day, subjects were instructed to consume only the supplied Lean Cuisine beef lasagna at their usual dinner time as a standardized meal. Subjects were asked not to consume any other foods until attending the sensory laboratory the following day.

A satiety questionnaire was filled out immediately prior and after breakfast and immediately prior and after lunch . The satiety questionnaire indicated perceived satiety using 100mm visual analogue scales (VAS) where 0 mm represented “not at all” and 100 mm represented “extremely,” in response to questions such as, “How full are you?” and “How hungry are you?” Liking of the foods presented at the buffet lunch was also assessed with a 9-point hedonic scale, as intake of food items may be driven by liking.

Intervention code [1] 286286 0
Lifestyle
Comparator / control treatment
Subjects will act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 288596 0
Amount of food consumed in energy and grams at lunch following a high fat breakfast. The amount remaining was measured following the buffet lunch and measured in grams. This was then analyzed for energy consumption using FoodWorks software.
Timepoint [1] 288596 0
Measured post lunch.
Secondary outcome [1] 300562 0
Perceived satiety using 100 mm VAS scales from satiety questionnaire. Participants were asked to rate hunger levels, fullness levels, likelihood of snack consumption and likelihood of whole meal consumption.
Timepoint [1] 300562 0
Prior to and post breakfast and prior to and post lunch.

Eligibility
Key inclusion criteria
Adults >18 years
Non Smoking
Non vegetarian or other food restrictions
No food allergies
Adults living in Melbourne
Adults who are able to attend Deakin University Sensory Laboratory and participate in testing in the hours of 9am-6pm Monday-Friday
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with food allergies, intolerances or restrictions
Smokers

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286535 0
University
Name [1] 286535 0
Deakin University, School of Exercise and Nutritional Sciences, Centre for Physical Activity and Nutritional Sciences
Country [1] 286535 0
Australia
Primary sponsor type
University
Name
Deakin University, School of Exercise and Nutritional Sciences, Centre for Physical Activity and Nutritional Sciences
Address
Deakin University, School of Exercise and Nutritional Sciences, Centre for Physical Activity and Nutritional Sciences
221 Burwood Highway
Burwood
VIC 3125
Country
Australia
Secondary sponsor category [1] 285322 0
None
Name [1] 285322 0
Address [1] 285322 0
Country [1] 285322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288605 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 288605 0
Ethics committee country [1] 288605 0
Australia
Date submitted for ethics approval [1] 288605 0
Approval date [1] 288605 0
Ethics approval number [1] 288605 0
HEAG-H 20_2012.

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

Contacts
Principal investigator
Name 36886 0
Miss Kaylee Azzopardi
Address 36886 0
School of Exercise and Nutrition Sciences Deakin University
221 Burwood Highway
Burwood
VIC
3125
Country 36886 0
Australia
Phone 36886 0
+61414 660 928
Fax 36886 0
Email 36886 0
[email protected]
Contact person for public queries
Name 36887 0
Kaylee Azzopardi
Address 36887 0
School of Exercise and Nutrition Sciences Deakin University
221 Burwood Highway
Burwood
VIC
3125
Country 36887 0
Australia
Phone 36887 0
+61414 660 928
Fax 36887 0
Email 36887 0
[email protected]
Contact person for scientific queries
Name 36888 0
Russell Keast
Address 36888 0
School of Exercise and Nutrition Sciences Deakin University
221 Burwood Highway
Burwood
VIC
3125
Country 36888 0
Australia
Phone 36888 0
+61 03 9244 6944
Fax 36888 0
Email 36888 0
[email protected]

No information has been provided regarding IPD availability


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.