Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001072909
Ethics application status
Approved
Date submitted
14/10/2011
Date registered
17/10/2011
Date last updated
2/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Peanuts on Appetite and Feeling of Fullness
Scientific title
Effect of Peanuts in Overweight but Otherwise Healthy Adults on Satiety and Appetite Regulation
Secondary ID [1] 273209 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 278975 0
Condition category
Condition code
Diet and Nutrition 279151 279151 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled cross over trial with 3 treatment arms; arm 1 (~60-80g Hi Oleic peanuts), arm 2 (~60-80g regular peanuts), arm 3 (~70-90g low salt potato crisps - control) the foods will provide ~15% of participants energy intake.
Participants will consume the snack on day 1 after an overnight fast and then complete visual analogue scales (for hunger appetite, thirst, fullness and amount they could consume), at baseline and t= 30, 60 120 180 minutes. Participants will then consume a buffet meal and energy intake from this meal will be calculated. Participants will then consume the snack food daily for the following 3 days and complete food intake records. After a minimum 4 day washout period between each food, they will cross over to the other snack foods. The order if which foods are consumed will be determined using a Latin-square design
Intervention code [1] 269545 0
Treatment: Other
Comparator / control treatment
low salt potato crisps 70-90g (15% of participant energy intake)eaten for 4 days
Control group
Active

Outcomes
Primary outcome [1] 279791 0
To determine energy intake from the buffet meal (after consumption of trial snack food).This will be measured by weighing foods pre and post consumption to determine amount eaten and then analysing using Foodworks computer program to determine energy intake.
Timepoint [1] 279791 0
Time point: 180 mins after the consumption of each of the three trial snack foods
Secondary outcome [1] 294435 0
Secondary Outcome 1: Ratings of appetite, fullness, hunger and thirst and desire to eat.(Visual analogue scales)
Timepoint [1] 294435 0
Time point: t= -15, 0, 30, 60, 120, 180 mins after consumption of snack
Secondary outcome [2] 294436 0
Secondary Outcome 2: Average energy intake calculated from weighed food record diaries.
Timepoint [2] 294436 0
Time point: Days 1, 2 3 and 4

Eligibility
Key inclusion criteria
Overweight (BMI 25-35 kg/m2)
Stable weight (<5% change) over past 3 months
Women post-menopausal (self-reported cessation of menses >12 mths)
Healthy adults
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Allergy to peanuts or any other nuts
-Current Smoker or use of nicotine replacement therapy
-Restrained eater (assessed by a 3-factor eating questionnaire using a cut off for restraint <12 (Stunkard & Messick 1985).
-Condition or medication which may affect the outcome e.g. thyroid condition, diabetes, medication which may effect appetite.
-Regular nut consumers (>30g/week nuts consumed usually)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects meeting entry criteria at screening will be allocated to a treatment at random by the study code-holder who will remain blinded to their identities.

A randomisation schedule will be generated by a random number generator which will match participant identification numbers with order of treatment allocation. Treatment allocation will be single-blind.
As the foods used look different participants will not be blinded to which food they are consuming but the primary researcher analysing the data will be blinded to which treatment phase participants are engaged in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into 6 groups of equal numbers using a random number generator. Foods will be allocated a letter A-F for identification and will not be decoded until all the data has been analysed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/10/2011
Actual
24/10/2011
Date of last participant enrolment
Anticipated
1/11/2011
Actual
1/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 4597 0
5000
Recruitment postcode(s) [2] 4598 0
5002
Recruitment postcode(s) [3] 4599 0
5003
Recruitment postcode(s) [4] 4600 0
5004
Recruitment postcode(s) [5] 4601 0
5006
Recruitment postcode(s) [6] 4602 0
5007
Recruitment postcode(s) [7] 4603 0
5008
Recruitment postcode(s) [8] 4604 0
5009
Recruitment postcode(s) [9] 4605 0
5010
Recruitment postcode(s) [10] 4606 0
5011
Recruitment postcode(s) [11] 4607 0
5012
Recruitment postcode(s) [12] 4608 0
5013
Recruitment postcode(s) [13] 4609 0
5014
Recruitment postcode(s) [14] 4610 0
5015
Recruitment postcode(s) [15] 4611 0
5016
Recruitment postcode(s) [16] 4612 0
5017
Recruitment postcode(s) [17] 4613 0
5018
Recruitment postcode(s) [18] 4614 0
5019
Recruitment postcode(s) [19] 4615 0
5020
Recruitment postcode(s) [20] 4616 0
5021
Recruitment postcode(s) [21] 4617 0
5022
Recruitment postcode(s) [22] 4618 0
5023
Recruitment postcode(s) [23] 4619 0
5024
Recruitment postcode(s) [24] 4620 0
5025
Recruitment postcode(s) [25] 4621 0
5026
Recruitment postcode(s) [26] 4622 0
5027
Recruitment postcode(s) [27] 4623 0
5028
Recruitment postcode(s) [28] 4624 0
5029
Recruitment postcode(s) [29] 4625 0
5030
Recruitment postcode(s) [30] 4626 0
5031
Recruitment postcode(s) [31] 4627 0
5031
Recruitment postcode(s) [32] 4628 0
5032
Recruitment postcode(s) [33] 4629 0
5033
Recruitment postcode(s) [34] 4630 0
5034
Recruitment postcode(s) [35] 4631 0
5035
Recruitment postcode(s) [36] 4632 0
5036
Recruitment postcode(s) [37] 4633 0
5037
Recruitment postcode(s) [38] 4634 0
5038
Recruitment postcode(s) [39] 4635 0
5039
Recruitment postcode(s) [40] 4636 0
5040
Recruitment postcode(s) [41] 4637 0
5041
Recruitment postcode(s) [42] 4638 0
5042
Recruitment postcode(s) [43] 4639 0
5043
Recruitment postcode(s) [44] 4640 0
5044
Recruitment postcode(s) [45] 4641 0
5045
Recruitment postcode(s) [46] 4642 0
5046
Recruitment postcode(s) [47] 4643 0
5047
Recruitment postcode(s) [48] 4644 0
5048
Recruitment postcode(s) [49] 4645 0
5049
Recruitment postcode(s) [50] 4646 0
5050
Recruitment postcode(s) [51] 4647 0
5051
Recruitment postcode(s) [52] 4648 0
5052

Funding & Sponsors
Funding source category [1] 270038 0
Government body
Name [1] 270038 0
Australian Research Council Linkage Grant
Country [1] 270038 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Peanut Company of Australia
Address
133 Haly Street (PO Box 26), Kingaroy, QLD, 4610
Country
Australia
Secondary sponsor category [1] 269009 0
University
Name [1] 269009 0
University of South Australia
Address [1] 269009 0
City East Campus
Frome Rd
Adelaide 5001
SA
Country [1] 269009 0
Australia
Secondary sponsor category [2] 269010 0
None
Name [2] 269010 0
Address [2] 269010 0
Country [2] 269010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271991 0
University of South Australia
Ethics committee address [1] 271991 0
Ethics committee country [1] 271991 0
Australia
Date submitted for ethics approval [1] 271991 0
09/05/2011
Approval date [1] 271991 0
14/10/2011
Ethics approval number [1] 271991 0
24181

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

Contacts
Principal investigator
Name 33270 0
Ms Jayne Barbour
Address 33270 0
Nutritional Physiology Research Centre University of South Australia Frome Road Adelaide 5001 SA Australia
Country 33270 0
Australia
Phone 33270 0
+61 883022348
Fax 33270 0
Email 33270 0
[email protected]
Contact person for public queries
Name 16517 0
Jayne Barbour
Address 16517 0
Nutritional Physiology Research Centre
University of South Australia Frome Road
Adelaide 5001
SA
Australia
Country 16517 0
Australia
Phone 16517 0
+61 8 83022348
Fax 16517 0
Email 16517 0
[email protected]
Contact person for scientific queries
Name 7445 0
Dr Alison Coates
Address 7445 0
University of South Australia Frome Road
Adelaide 5001
SA
Australia
Country 7445 0
Australia
Phone 7445 0
+61 8 83022313
Fax 7445 0
Email 7445 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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