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Trial registered on ANZCTR


Registration number
ACTRN12618001735246
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
22/10/2018
Date last updated
6/11/2019
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
6/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of beer and non-alcoholic beer consumption on adult drinkers' liking of snack foods.
Scientific title
Evaluating the impact of consuming a moderate dose of beer and non-alcoholic beer on the liking and characteristics of different snack foods: a pilot randomised crossover trial
Secondary ID [1] 296292 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 309966 0
Condition category
Condition code
Diet and Nutrition 308740 308740 0 0
Other diet and nutrition disorders
Mental Health 308864 308864 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Alcoholic beer and lemonade. Alcoholic beer will be provided in two of the four arms. These two intervention arms are: 1) alcoholic beer and commonly consumed snacks and; 2) alcoholic beer and uncommonly consumed snacks.

Participants will be provided with 30g of alcohol (760mL of alcoholic beer) and lemonade (255mL) on each of the two testing evening. Participants will have 15 minutes to consume the beer. A randomly allocated set of snacks (either commonly consumed savoury snacks or uncommonly consumed savoury snacks) will then be provided 30 minutes after consuming the beer and lemonade. Participants will be asked to rate their liking of the snacks and their characteristics.

There is a washout period of at least one week between treatment arms.
Intervention code [1] 312622 0
Lifestyle
Intervention code [2] 312707 0
Behaviour
Comparator / control treatment
Comparator: Non-alcoholic beer and lemonade. Non-alcoholic beer will be provided in two of the four arms. These two comparator arms are: 1) non-alcoholic beer and commonly consumed snacks and; 2) non-alcoholic beer and uncommonly consumed snacks.

Participants will be provided with non-alcoholic beer (760mL) and lemonade (255mL). Participants will have 15 minutes to consume the non-alcoholic beer and lemonade. A randomly allocated set of snacks will then be provided 30 minutes after consuming the non-alcoholic beer and lemonade. Participants will be asked to rate their liking of the snacks and their characteristics.

There is a washout period of at least one week between treatment arms.
Control group
Active

Outcomes
Primary outcome [1] 307728 0
Subjective ratings of flavour of the food snacks, as measured by the 9-point hedonic scales.
Timepoint [1] 307728 0
At three hours after the commencement of each testing evening.
Primary outcome [2] 307833 0
Subjective ratings of texture of the food snacks, as measured by the 9-point hedonic scales.
Timepoint [2] 307833 0
At three hours after the commencement of each testing evening.
Primary outcome [3] 307834 0
Subjective ratings of mouth-feel of the food snacks, as measured by the 9-point hedonic scales.
Timepoint [3] 307834 0
At three hours after the commencement of each testing evening.
Secondary outcome [1] 352665 0
Subjective ratings of liking of the appearance of the food snacks, as measured by the 9-point hedonic scales. This is a primary outcome.
Timepoint [1] 352665 0
At three hours after the commencement of each testing evening.
Secondary outcome [2] 352666 0
Subjective ratings of overall liking of the food snacks, as measured by the 9-point hedonic scales.
Timepoint [2] 352666 0
At three hours after the commencement of each testing evening.
Secondary outcome [3] 352667 0
% breath alcohol concentration as measured by an Alcolimit breathalyser.
Timepoint [3] 352667 0
A measurement will be collected before drinking the beverage. Measurements will then be collected at baseline, 30, 45, 60 90, 120 and 180 minutes after consuming either alcoholic beer or non-alcoholic beer using area under the curve.
Secondary outcome [4] 353078 0
Food preferences, as measured by the Leeds Food Preference Questionnaire
Timepoint [4] 353078 0
Immediately before baseline and at 15 minutes after consuming either alcoholic beer or non-alcoholic beer.
Secondary outcome [5] 353079 0
Hunger ratings, as measured by Visual Analogue Scales.
Timepoint [5] 353079 0
A measurement will be collected before drinking the beverage. At baseline, 15, 30, 45, 60 90, 120 and 180 minutes after consuming either alcoholic beer or non-alcoholic beer using area under the curve.
Secondary outcome [6] 353080 0
Desire to eat ratings, as measured by Visual Analogue Scales.
Timepoint [6] 353080 0
A measurement will be collected before drinking the beverage. At baseline, 15, 30, 45, 60 90, 120 and 180 minutes after consuming either alcoholic beer or non-alcoholic beer using area under the curve.
Secondary outcome [7] 353082 0
Fullness ratings, as measured by Visual Analogue Scales
Timepoint [7] 353082 0
A measurement will be collected before drinking the beverage. At baseline, 15, 30, 45, 60 90, 120 and 180 minutes after consuming either alcoholic beer or non-alcoholic beer using area under the curve.

Eligibility
Key inclusion criteria
This study is recruiting healthy 18 to 65 year old adult male drinkers with a Body Mass Index between 18.5kg/m2 and 30kg/m2 who like and eat savoury snacks such as crisps, biscuits and dips.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Consume less than one standard drink per fortnight or less than two standard drinks per month.
2. Engage in excessive or risky drinking
3. Diagnosed with Type 1 or Type 2 Diabetes or that on screening, not have a random blood glucose reading above 8.0mmol/L
4. Pregnant or breastfeeding
5. Smoker
6. Unable to tolerate lactose (i.e. have lactose intolerance but not using lactase tablets to manage symptoms)
7. Allergic or sensitive to nuts or nut products (nut allergy)
8. Allergic to cow’s milk protein (milk allergy)
9. Allergic to egg protein (egg allergy)
10. Allergic to wheat (wheat allergy)
11. Allergic to sesame seeds (sesame allergy)
12. Allergic to fish and crustaceans (fish allergy and crustacean allergy)
13. Intolerant to gluten (coeliac disease)
14. Vegan or unable to eat foods with dairy and egg products
15. Have dietary restrictions, such as for cultural reasons (i.e. requiring Halal and/or Kosher foods)
16. Have an implanted cardiac defibrillator, active prostheses, cardiac pacemaker or have open wounds on hands and/or feet
17. 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
This is a four-arm randomised crossover trial
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 30 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, Repeated Measures Analysis of Variance (ANOVA) and independent samples t-tests.

The specific plan for the statistical tests and outcome measures are:

Area Under the Curve (over 180 minutes)
- Breath alcohol concentration %
- Hunger, desire to eat and fullness ratings

Repeated measures ANOVA (comparisons across all four groups)
- 9-point hedonic scales
- Breath alcohol concentration area under the curve
- Food preferences via the Leeds Food Preference Questionnaire
- Hunger, desire to eat and fullness ratings area under the curve

Independent samples t-test (for comparison between individual groups)
- 9-point hedonic scales
- Breath alcohol concentration area under the curve
- Food preferences via the Leeds Food Preference Questionnaire
- Hunger, desire to eat and fullness ratings area under the curve

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2018
Actual
5/11/2018
Date of last participant enrolment
Anticipated
1/03/2019
Actual
28/05/2019
Date of last data collection
Anticipated
1/05/2019
Actual
12/07/2019
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 24296 0
3168 - Clayton
Recruitment postcode(s) [2] 24297 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 300884 0
Charities/Societies/Foundations
Name [1] 300884 0
Coopers Brewery Foundation
Country [1] 300884 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] 300448 0
Other Collaborative groups
Name [1] 300448 0
Hudson Institute of Medical Research
Address [1] 300448 0
27-31 Wright Street,
Clayton 3168 VIC
Australia
Country [1] 300448 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301657 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 301657 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] 301657 0
Australia
Date submitted for ethics approval [1] 301657 0
17/08/2018
Approval date [1] 301657 0
01/10/2018
Ethics approval number [1] 301657 0
14765

Summary
Brief summary
This study will investigate the impact of consuming alcoholic beer against non-alcoholic beer on the the liking and characteristics of two different sets of savoury food snacks (common food snacks and uncommon food snacks).

Participants in this study will attend the study on four x 4 hour testing evenings and will be randomly allocated to a beverage (either a moderate serving of alcoholic beer and lemonade or non-alcoholic beer and lemonade) and to a set of snacks (either common and uncommon food snacks) on each evening. Participants will consume the provided beverages within 15 minutes 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 throughout each testing evening include multiple appetite and hunger ratings, breath alcohol concentration measurements and food preference questionnaires. After each testing evening, participants will also complete a 2-day food intake diary which will record all the foods and beverages the participants eat for the two days after each testing evening.

The results from this study will assist with understanding the impact of drinking beer on the perception of snacks. This will provide evidence to develop new snack options to have when drinking alcoholic beverages.
Trial website
Trial related presentations / publications
Public notes
This study will use deception to conceal the true purpose of the study from participants and hence, the official scientific title for this study has been added to these private notes. The title of this study is "Evaluating the impact of alcoholic beverage consumption on dietary-energy intake from high protein snacks and standard protein snacks: a pilot study". This study has received approval from the Monash University Human Research Ethics Committee and a copy of the original certificate of approval has been provided. A specific certificate for the use of deception has been attached in the supporting documentation.

Aims
The true aim of this study is to investigate the impact of consuming alcoholic beer, against non-alcoholic beer, on the dietary energy intake of standard protein snacks and high protein snacks. The false aim of this study, which is proposed to be publicly viewable, is to investigate the impact of consuming alcoholic beer, against non-alcoholic beer, on the liking of commonly consumed snacks and uncommonly consumed snacks.

Intervention and comparators
With regards to the intervention and comparator, the intervention is alcoholic beer with diet lemonade (negligible energy content) whereas the comparator is non-alcoholic beer with lemonade with added Polyjoule (maltodextrin). The Polyjoule is added to the lemonade so that the intervention and comparator are isocaloric (i..e very similar energy content). This allows the research team to rule out the confounding variable of differing energy content. Participants will not be informed that different lemonade will be used with the intervention and comparator arms, nor will they be informed about the use of Polyjoule.

This study will use two different sets of snack foods: standard protein snack foods with a standard dairy dip and high protein snack foods with a protein-fortified dip. As the research team would not like to disclose the protein content of the snacks and dip to the participants since this may also influence snack intake, the snacks have been renamed. Standard protein snacks are renamed as commonly consumed snacks and high protein snacks are renamed as uncommonly consumed snacks.

Outcome measures
This study's primary outcome measure is dietary energy intake, which will be calculated from food snack mass intake, will not be revealed to participants as it may influence how much snacks are eaten after consuming either alcoholic beer or non-alcoholic beer. Instead, participants will be informed that the study will investigate the effect of consuming either alcoholic beer or non-alcoholic beer on the liking of the snack foods. The snack foods will be provided to participants for ad-libitum consumption.

A secondary outcome measure that has not been added to the publicly view notes is the 2-day food intake diary. We are interested to see if participants will compensate for their dietary energy intake in the following two days after completing each study testing. This data will be analysed to determine if alcoholic beverage consumption results in short-term dietary energy compensation compared with non-alcoholic beverage consumption, across the four testing days. As adding this to the publicly viewable statistical analysis plan will imply we are measuring energy intake on the following days after the study, we have included it here in the private notes.

With regards to the statistical analyses, this is the expected plan with all included outcome measures.

Area Under the Curve (over 180 minutes)
- Breath alcohol concentration %
- Hunger, desire to eat and fullness ratings

Repeated measures ANOVA (comparisons across all four groups)
- 9-point hedonic scales
- Food energy intake
- Breath alcohol concentration area under the curve
- Food preferences via the Leeds Food Preference Questionnaire
- Hunger, desire to eat and fullness ratings area under the curve
- 2-day food intake diary

Independent samples t-test (for comparison between individual groups)
- 9-point hedonic scales
- Food energy intake
- Breath alcohol concentration area under the curve
- Food preferences via the Leeds Food Preference Questionnaire
- Hunger, desire to eat and fullness ratings area under the curve
- 2-day food intake diary
Attachments [1] 3147 3147 0 0
/AnzctrAttachments/376157-Project 14765- Certificate of Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 87686 0
Dr Aimee Dordevic
Address 87686 0
Monash University Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 87686 0
Australia
Phone 87686 0
(+613) 9905 2142
Fax 87686 0
Email 87686 0
aimee.dordevic@monash.edu
Contact person for public queries
Name 87687 0
Mr Alastair Kwok
Address 87687 0
Monash University Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 87687 0
Australia
Phone 87687 0
+613 (9902 4199)
Fax 87687 0
Email 87687 0
alastair.kwok@monash.edu
Contact person for scientific queries
Name 87688 0
Dr Aimee Dordevic
Address 87688 0
Monash University Department of Nutrition, Dietetics & Food
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 87688 0
Australia
Phone 87688 0
(+613) 9905 2142
Fax 87688 0
Email 87688 0
aimee.dordevic@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
Individual participant data will not be publicly available. Pooled participant data may be available upon request.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary