Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
Trial registered on ANZCTR


Registration number
ACTRN12615001129572
Ethics application status
Approved
Date submitted
10/10/2015
Date registered
26/10/2015
Date last updated
17/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of oral taste sensitivity on satiety and nutrients intake in human subjects
Scientific title
Influence of oral taste sensitivity on satiety and nutrient intake after different soup preloads:A randomized, crossover study in adult human subjects
Secondary ID [1] 287637 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 296462 0
Condition category
Condition code
Diet and Nutrition 296718 296718 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 296719 296719 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 296773 296773 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be screened based on their taste sensitivity to sucrose and MSG before they participate into the soup preload and eating behavior study..

The study will be conducted over 3 non-consecutive test days with one-week interval at the sensory laboratory at the University of Queensland.Three different soups will be tested:
1- control soup: 12g plain flour + 200ml water;
2-MSG soup: 12g plain flour + 1g MSG + 200ml water;
3-sweet soup: 9.6g plain flour + 2g sucrose + 200ml water;
Participants will arrive at 8:00 - 8:30 a.m. in a fasted state having consumed nothing but water from at least 2300 hours the night before. After brief introduction and the first saliva collection, they will be provided with 200ml of either MSG soup, placebo soup or Sweet soup in randomised order 10 min after arrival. The washout time between two soup conditions was one-week. They will be asked to finish the soup within 5 minutes using a given spoon. Subjects will then stay in the lab for 60 minutes before the buffet meal was provided. They will choose any kinds of food and consume as much or as little as they want until reach comfortably fullness and satiation. Participants are free to ask for more foods if they finish any of the food served. The ad libitum meal session will last for up to 40 minutes..
Subjects will also taste 5ml samples of MSG and sweet soup before preload, then at 0 minute and 60 minutes after the soup preload. Soup pleasantness was measured by rating on a visual analogue scale after tasting the sample. Subjective appetite and sensory specific appetite will be measured using visual analogue scales. Saliva samples will be taken at the following time points: arrival, 0min, 30 min 60 min after the soup and after the ad libitum meal.
Intervention code [1] 293038 0
Behaviour
Comparator / control treatment
cross-over intervention. All participants will consume all three types of soups.. The sweet soup, the MSG soup and the control soup.
Control group
Placebo

Outcomes
Primary outcome [1] 296334 0
sensory specific satiety to sweet soup/MSG soup; subjects will rate the pleasantness on visual analogue scale with very unpleasant and very pleasant at the two ends, after tasting a small sample of the sweet soup and the MSG soup, both before and at two time points (0min and 60min) after soup consumption, sensory specific satiety score will be calculated with the subjective ratings;
Timepoint [1] 296334 0
Before soup preload and at both 0 minute and at 60 minutes after soup preload consumption
Primary outcome [2] 296335 0
Macronutrients and energy intake, All food items will be weighed before and after consumption to calculate the quantity of each food item consumed, the macronutrients and energy consumption will be further calculated based on the nutritional value provided by manufacturer with the amount (gram) of food consumed.
Timepoint [2] 296335 0
Directly after the ad libitum Buffet food eating at each of the 3 testing sessions
Secondary outcome [1] 318198 0
Appetite/satiety sensations (hunger/fullness) using a labeled magnitude satiety scale (LMSS);
Timepoint [1] 318198 0
At arrival, 0, 15, 30, 60 minutes after soup preload and after ad libitum meal
Secondary outcome [2] 318396 0
Appetite/satiety sensation (subjective desire to eat) using a visual analogue scale (VAS);
Timepoint [2] 318396 0
At arrival, 0, 15, 30, 60 minutes after soup preload and after ad libitum meal
Secondary outcome [3] 318397 0
Appetite/satiety sensation (subjective ratings on how much food they think they can eat, also known as perspective food consumption) on a visual analogue scale (VAS);
Timepoint [3] 318397 0
At arrival, 0, 15, 30, 60 minutes after soup preload and after ad libitum meal
Secondary outcome [4] 318398 0
Hormone in saliva: ghrelin, GLP-1 and leptin will be measured using ELISA
Timepoint [4] 318398 0
At arrival, 0, 30, 60 minutes after soup preload and after ad libitum meal

Eligibility
Key inclusion criteria
Healthy, non-vegetarian. Everyone who shows interest in participating the study, judge themselves as healthy and do not meet the exclusion criteria.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking
vegetarian
difficulties with eating or swallowing
taste/olfactory dysfunction

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/11/2014
Date of last participant enrolment
Anticipated
Actual
1/11/2015
Date of last data collection
Anticipated
Actual
16/11/2015
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292201 0
University
Name [1] 292201 0
The University of Queensland
Country [1] 292201 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland, St Lucia,4072, Brisbane, QLD
Country
Australia
Secondary sponsor category [1] 290939 0
None
Name [1] 290939 0
Address [1] 290939 0
Country [1] 290939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293671 0
The University of Queensland Behavioral & Social Sciences Ethical Review Committee
Ethics committee address [1] 293671 0
Ethics committee country [1] 293671 0
Australia
Date submitted for ethics approval [1] 293671 0
Approval date [1] 293671 0
27/08/2014
Ethics approval number [1] 293671 0
2014001036

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

Contacts
Principal investigator
Name 60878 0
Mr Pengfei Han
Address 60878 0
C504 Hartley Teakle Building (83#), Center for Nutrition and Food Sciences, the University of Queensland, St Lucia, 4072, QLD
Country 60878 0
Australia
Phone 60878 0
+61 426 882 330
Fax 60878 0
Email 60878 0
[email protected]
Contact person for public queries
Name 60879 0
Eugeni Roura
Address 60879 0
S435 Hartley Teakle Building (83#), Center for Nutrition and Food Sciences, the University of Queensland, St Lucia, 4072, QLD
Country 60879 0
Australia
Phone 60879 0
+61 (0)7 3365 2526
Fax 60879 0
Email 60879 0
[email protected]
Contact person for scientific queries
Name 60880 0
Eugeni Roura
Address 60880 0
S435 Hartley Teakle Building (83#), Center for Nutrition and Food Sciences, the University of Queensland, St Lucia, 4072, QLD
Country 60880 0
Australia
Phone 60880 0
+61 (0)7 3365 2526
Fax 60880 0
Email 60880 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
SourceTitleYear of PublicationDOI
EmbaseSalivary leptin and TAS1R2/TAS1R3 polymorphisms are related to sweet taste sensitivity and carbohydrate intake from a buffet meal in healthy young adults.2017https://dx.doi.org/10.1017/S0007114517002872
N.B. These documents automatically identified may not have been verified by the study sponsor.