Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000967482
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
22/07/2016
Date last updated
6/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of activating nuts on acceptance and gastrointestinal tolerance among healthy individuals
Scientific title
The effects of activating nuts on acceptance and gastrointestinal tolerance among healthy individuals: a randomised crossover study
Secondary ID [1] 289718 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal intolerance 299548 0
Condition category
Condition code
Diet and Nutrition 299524 299524 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised crossover study with four arms:
Arm 1: 30g per day of whole raw almonds
Arm 2: 30g per day of sliced raw almonds
Arm 3: 30g per day of whole soaked almonds
Arm 4: 30g per day of sliced soaked almonds
This study will assess the effects of consuming 4 different types of almonds on consumer acceptance and gastrointestinal tolerance. Participant will be assigned in random order to receive the 4 treatments. Each treatment will last 12 days, with a 2 day washout between treatments.
Participants can eat the almonds anyway time of the day, and can choose to eat them how they wish.
The almonds will be soaked in water (2 cups of water per 1 cup of nuts) containing 1 tsp of salt per cup of nuts, for 24 hours. The nuts will then be dried for either 12 hours (whole nuts) or 8 hours (sliced nuts) at 65 degrees Celcius.
Participants will be supplied with their daily portion of 30 g of nuts in individual bags. Adherence will be monitored by the return of these bags. Any uneaten nuts will be weighed.
Intervention code [1] 295354 0
Other interventions
Comparator / control treatment
The raw nuts will be compared to the soaked nut treatments
Control group
Active

Outcomes
Primary outcome [1] 299002 0
Acceptance. This will be measure on a 10cm visual analogue scale.
Timepoint [1] 299002 0
Daily over the 12 day intervention period
Secondary outcome [1] 325851 0
Gastrointestinal tolerance.
Incidence will be measure by a yes/no response.
If participants respond 'yes' we will measure severity on a 10cm visual analogue scale.
Timepoint [1] 325851 0
Daily over the 12 day intervention period

Eligibility
Key inclusion criteria
Healthy males and females aged 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with allergies or intolerances to nuts
Pregnant women

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 will involve contacting the holder of the allocation scedulem who is an off-site biostatistician
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The outcomes will be modelled using linear mixed models with random participant and random participant effects to accommodate the two levels of repeated measures. Where othe overall test for differences between treatments is significant, pairwise comparisons between groups will be made. For gastrointestinal tolerance, baseline values will also be controlled for. All analysis will be performed using Stata Statistical Software 12.0 (Statacorp LP, College Station TX, USA). All tests will be performed at the two-sided 0.05 level.

To provide 90% power to detect a mean difference of 10 mm in acceptance ratings between any two nut types (soaked vs unsoaked), for a particular form, (whole, sliced), and any two nut forms for a particular type, or an two combinations of nut type and form, assuming a standard deviation of 25 mm, which is consistent with our other research and reflects a standardised effect size of 0.4 which can be seen as a small-to-medium difference, using a two-sided significant level of 5% and assuming a correlation of 0.7 or higher between repeated measures, 66 participants would be required with complete data. Allowing for 10% missing or unusable data, 74 participants would need to be recruited.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/07/2016
Actual
25/07/2016
Date of last participant enrolment
Anticipated
15/08/2016
Actual
15/08/2016
Date of last data collection
Anticipated
19/09/2016
Actual
7/10/2016
Sample size
Target
74
Accrual to date
Final
76
Recruitment outside Australia
Country [1] 8043 0
New Zealand
State/province [1] 8043 0
Otago

Funding & Sponsors
Funding source category [1] 294097 0
University
Name [1] 294097 0
University of Otago
Country [1] 294097 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin
9013
Country
New Zealand
Secondary sponsor category [1] 292929 0
None
Name [1] 292929 0
Address [1] 292929 0
Country [1] 292929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295513 0
University of Otago HUman Ethics Committee
Ethics committee address [1] 295513 0
Ethics committee country [1] 295513 0
New Zealand
Date submitted for ethics approval [1] 295513 0
09/05/2016
Approval date [1] 295513 0
20/05/2016
Ethics approval number [1] 295513 0
16/072

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

Contacts
Principal investigator
Name 67562 0
Dr Rachel Brown
Address 67562 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9013
Country 67562 0
New Zealand
Phone 67562 0
+64 3 479 5839
Fax 67562 0
Email 67562 0
[email protected]
Contact person for public queries
Name 67563 0
Rachel Brown
Address 67563 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9013
Country 67563 0
New Zealand
Phone 67563 0
+64 3 479 5839
Fax 67563 0
Email 67563 0
[email protected]
Contact person for scientific queries
Name 67564 0
Rachel Brown
Address 67564 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9013
Country 67564 0
New Zealand
Phone 67564 0
+64 3 479 5839
Fax 67564 0
Email 67564 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
EmbaseThe effects of 'activating' almonds on consumer acceptance and gastrointestinal tolerance.2018https://dx.doi.org/10.1007/s00394-017-1543-7
N.B. These documents automatically identified may not have been verified by the study sponsor.