Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000136303
Ethics application status
Approved
Date submitted
18/01/2017
Date registered
25/01/2017
Date last updated
3/05/2019
Date data sharing statement initially provided
3/05/2019
Date results information initially provided
3/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of alcohol consumption on adult social drinkers' liking of snack foods
Scientific title
Evaluating the impact of consuming a moderate dose of alcohol on the liking and characteristics of different snack foods: a pilot randomised crossover trial
Secondary ID [1] 290914 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Promotion of healthy eating 301674 0
Condition category
Condition code
Diet and Nutrition 301382 301382 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with 30g of alcohol (in the form of wine) on each of the two testing evening. Participants will have 15 minutes to consume the wine. A randomly allocated set of snacks (intervention or control) will then be provided 30 minutes after the end of alcohol consumption. The washout period between testing evenings (i.e. the provision of different snacks) is a minimum of one week.

Intervention: Uncommon snacks and dip

Participants will be provided with a set of less commonly eaten savoury food snacks after drinking the moderate dose of alcohol and will consume the snacks until they are comfortably full. Participants will be asked to rate their liking of the uncommon snacks and their characteristics.
Intervention code [1] 296886 0
Lifestyle
Comparator / control treatment
Control: Common snacks and dip

Participants will be provided with a set of commonly eaten savoury food snacks after drinking the moderate dose of alcohol and will consume the snacks until they are comfortably full. Participants will be asked to rate their liking of the common snacks and their characteristics.
Control group
Active

Outcomes
Primary outcome [1] 300786 0
Subjective ratings of the five characteristics (flavour, texture, mouth-feel, liking of the appearance and overall liking) of the food snacks, as measured by five 9-Point Hedonic Scales.
Timepoint [1] 300786 0
At three hours after the commencement of each testing evening.
Secondary outcome [1] 330847 0
% Breath alcohol concentration as measured by an Alcolimit breathalyser.
Timepoint [1] 330847 0
At baseline, 30, 45, 60 90, 120 and 180 minutes after consuming a moderate alcohol dose using Area under the curve.
Secondary outcome [2] 331012 0
Blood glucose, insulin and lipids, as collected by blood samples via cannula and measured by serum and plasma assays.
Timepoint [2] 331012 0
At baseline, then 0, 15, 30, 45, 60, 90, 120 and 180 minutes after consuming a moderate dose of alcohol using Area under the curve.

Eligibility
Key inclusion criteria
This study is recruiting healthy 18 to 65 year old adult social drinkers with a Body Mass Index between 18.5kg/m2 to 30kg/m2 who like and eat savoury snacks such as crisps, nuts, biscuits and dips
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers who have any of the following of the key exclusion criteria will be unable to participate in this study:

1. Consume six or more standard drinks on more than two separate occasions in the last month and less than 4 or more than 64 standard drinks per month.
2. Diagnosed with Type 1 or Type 2 Diabetes or that on screening, not have a random blood glucose reading above 8.0mmol/L
3. Pregnant or breastfeeding
4. Smoker
5. Unable to tolerate lactose (i.e. have lactose intolerance but not using lactase tablets to manage symptoms)
6. Allergic or sensitive to nuts or nut products (nut allergy)
7. Allergic to cow’s milk protein (milk allergy)
8. Allergic to egg protein (egg allergy)
9. Allergic to wheat (wheat allergy)
10. Allergic to sesame seeds (sesame allergy)
11. Allergic to fish and crustaceans (fish allergy and crustacean allergy)
12. Intolerant to gluten (coeliac disease)
13. Vegan or unable to eat foods with dairy and egg products
14. Have dietary restrictions, such as for cultural reasons (i.e. requiring Halal and/or Kosher foods)
15. Have an implanted cardiac defibrillator, active prostheses, cardiac pacemaker or have open wounds on hands and/or feet
16. Currently dieting to lose weight and/or have an eating disorder

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)
Allocation is concealed in opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a pilot randomised crossover trial study so no sample size calculation has been used. A sample of 20 participants has been estimated to provide sufficient data for power calculations for potential larger studies.

The statistical analysis plan is expected to include Area Under the Curve, Analysis of Variance (ANOVA) and paired sample t-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
31/05/2018
Date of last data collection
Anticipated
31/08/2017
Actual
7/09/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15137 0
3000 - Melbourne
Recruitment postcode(s) [2] 15138 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 295379 0
Charities/Societies/Foundations
Name [1] 295379 0
Coopers Brewery Foundation
Country [1] 295379 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Nutrition, Dietetics & Food
Monash University, School of Clinical Sciences
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 294202 0
Other
Name [1] 294202 0
Hudson Institute of Medical Research
Address [1] 294202 0
27-31 Wright Street,
Clayton 3168 VIC
Australia
Country [1] 294202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296715 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 296715 0
Monash University Human Research Ethics Committee (MUHREC)
Room 111, Chancellery Building E,
24 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 296715 0
Australia
Date submitted for ethics approval [1] 296715 0
03/08/2016
Approval date [1] 296715 0
08/09/2016
Ethics approval number [1] 296715 0
2016-0383-516

Summary
Brief summary
This study will investigate the impact of consuming alcohol on the liking and characteristics of two different sets of savoury food snacks (newly developed food snacks, uncommon food snacks and common food snacks).

Participants in this study will attend the study on two testing evenings and will be randomly allocated to a different set of snacks on each evening. Participants will drink a moderate dose of alcohol and then consume the provided snacks until they are comfortably full. They will be asked to complete questionnaires on their liking of the different snack foods including the flavour, appearance, mouth-feel and texture. Other data that will be collected from participants on each testing evening include multiple appetite and hunger ratings, blood samples collected to observe changes in biomarkers and breath alcohol concentration measurements.

The results from this study will assist with the potential development of new food snacks to have when consuming alcohol for social drinkers.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1384 1384 0 0
/AnzctrAttachments/372162-2016-0383-516 Ethics Approval Document.pdf (Ethics approval)

Contacts
Principal investigator
Name 71706 0
Prof Helen Truby
Address 71706 0
Monash University Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 71706 0
Australia
Phone 71706 0
(+613) 9902 4261
Fax 71706 0
Email 71706 0
helen.truby@monash.edu
Contact person for public queries
Name 71707 0
Mr Alastair Kwok
Address 71707 0
Monash University Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 71707 0
Australia
Phone 71707 0
(+613) 9902 4199
Fax 71707 0
Email 71707 0
alastair.kwok@monash.edu
Contact person for scientific queries
Name 71708 0
Prof Helen Truby
Address 71708 0
Monash University Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 71708 0
Australia
Phone 71708 0
(+613) 9902 4261
Fax 71708 0
Email 71708 0
helen.truby@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants from this study may be enrolled in other on-going studies so as we are using modest levels of deception, we will not be releasing participant level data until our series of studies are completed


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.