Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000192886
Ethics application status
Approved
Date submitted
8/02/2012
Date registered
14/02/2012
Date last updated
2/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Peanuts on Blood Vessel Function, Memory and Thinking
Scientific title
To assess the effect of 12 week peanut consumption (in comparison to a low nut diet) on blood vessel function, cognitive performance and body composition in healthy overweight adults.
Secondary ID [1] 279901 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endothelial vasodilator function 285805 0
cognitive function 285806 0
Overweight/Obesity 285816 0
Condition category
Condition code
Cardiovascular 285982 285982 0 0
Diseases of the vasculature and circulation including the lymphatic system
Mental Health 285983 285983 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 285984 285984 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled cross over trial with 2 treatment arms; arm 1 (~60-80g Hi Oleic peanuts~15% of participants energy intake incorporated into the diet, consumed daily), arm 2 control (low nut diet). Participants will be randomised to consume either peanuts or low nut diet for 12 weeks and then swap over to alternate arm for the next 12 weeks. As the control arm is a low nut diet there is no washout phase, any changes from consuming peanuts are expected to be reversed in the 12 week control period. Peanuts will be provided in snack sized packets (25 g each) sufficient for 6 weeks intake, a second 6 week supply will be provided at the subsequent visit. The primary investigator (Jayne Barbour) is an Accredited Practicing Dietitian who will advise on adherence to low nut diet and peanut diet and monitor compliance by checking 4 day food diaries at 0, 6, 12, 18 and 24 weeks. Participants will also return empty peanut packets or uneaten peanuts as a measure of compliance. Red blood cell fatty acid content will also be taken at weeks 12 and 24 to check compliance with diets.
Intervention code [1] 284224 0
Lifestyle
Comparator / control treatment
low nut diet - participants will be advised by primary investigator (Dietitian) to avoid nuts wherever possible including all nuts as snacks and as main ingredients in a recipe (e.g. sate sauce, cakes with ground nuts)or packaged products with more than or equal to 5% nuts listed in the ingredients. Nuts in small/trace amounts will be allowed.
Control group
Active

Outcomes
Primary outcome [1] 286476 0
Primary outcome: Change in blood flow in middle cerebral artery as measured by TCD following peanut consumption compared with low nut diet
Timepoint [1] 286476 0
12 weeks and 24 weeks
Secondary outcome [1] 295958 0
Change in cognitive performance (Stroop colour word test, inspection time, coding, symbol search, initial and excluded letter fluency, Rey Auditory Verbal Leaning Test) following peanut consumption compared with low nut diet
Timepoint [1] 295958 0
12 weeks and 24 weeks
Secondary outcome [2] 295959 0
Change in body weight/composition; % body fat (DEXA scan), waist circumference, body weight and body mass index following peanut consumption compared with low nut diet
Timepoint [2] 295959 0
Time point: 12 weeks and 24 weeks
Secondary outcome [3] 295997 0
Change in vascular measures; supine blood pressure and arterial compliance following peanut consumption compared with low nut diet
Timepoint [3] 295997 0
Time point: 12 weeks and 24 weeks
Secondary outcome [4] 295998 0
Change in glucose metabolism; plasma glucose and insulin following peanut consumption compared with low nut diet
Timepoint [4] 295998 0
Time point: 12 weeks and 24 weeks
Secondary outcome [5] 295999 0
Change in lipid metabolism ; blood lipids following peanut consumption compared with low nut diet
Timepoint [5] 295999 0
Time point: 12 weeks and 24 weeks

Eligibility
Key inclusion criteria
overweight (BMI>25 kg/m2) healthy adults
females must be post-menopausal
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)must not have an allergy to peanuts or any other nuts
2)must not have cardiovascular, thyroid, disease, renal disease, diabetes or suffered a stroke
3)must not be a smoker or use nicotine replacement therapy
4)must not be a restrained eater
5)must not be a nut consumer (>30g nuts or peanut butter)
6)blood pressure must not exceed 160/100mmHg at screening visit
7)must not have cognitive impairment
8)weight greater than 135kg (DEXA limit)

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)
A randomisation schedule will be generated by a random number generator which will match participant identification numbers with order of treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into 2 groups of equal numbers using a random number generator. Treatment arms will be allocated a letter A- B 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
Active, not recruiting
Date of first participant enrolment
Anticipated
26/03/2012
Actual
26/03/2012
Date of last participant enrolment
Anticipated
8/02/2013
Actual
26/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4945 0
5001
Recruitment postcode(s) [2] 4946 0
5002
Recruitment postcode(s) [3] 4947 0
5003
Recruitment postcode(s) [4] 4948 0
5004
Recruitment postcode(s) [5] 4949 0
5005
Recruitment postcode(s) [6] 4950 0
5006
Recruitment postcode(s) [7] 4951 0
5008
Recruitment postcode(s) [8] 4952 0
5009
Recruitment postcode(s) [9] 4953 0
5010
Recruitment postcode(s) [10] 4954 0
5011
Recruitment postcode(s) [11] 4955 0
5012
Recruitment postcode(s) [12] 4956 0
5013
Recruitment postcode(s) [13] 4957 0
5014
Recruitment postcode(s) [14] 4958 0
5015
Recruitment postcode(s) [15] 4959 0
5016
Recruitment postcode(s) [16] 4960 0
5018
Recruitment postcode(s) [17] 4961 0
5017
Recruitment postcode(s) [18] 4962 0
5019
Recruitment postcode(s) [19] 4963 0
5020
Recruitment postcode(s) [20] 4964 0
5021
Recruitment postcode(s) [21] 4965 0
5022
Recruitment postcode(s) [22] 4966 0
5023
Recruitment postcode(s) [23] 4967 0
5025
Recruitment postcode(s) [24] 4968 0
5027
Recruitment postcode(s) [25] 4969 0
5028
Recruitment postcode(s) [26] 4970 0
5029
Recruitment postcode(s) [27] 4971 0
5031
Recruitment postcode(s) [28] 4972 0
5024
Recruitment postcode(s) [29] 4973 0
5032
Recruitment postcode(s) [30] 4974 0
5034
Recruitment postcode(s) [31] 4975 0
5035
Recruitment postcode(s) [32] 4976 0
5036
Recruitment postcode(s) [33] 4977 0
5026
Recruitment postcode(s) [34] 4978 0
5038
Recruitment postcode(s) [35] 4979 0
5039
Recruitment postcode(s) [36] 4980 0
5040
Recruitment postcode(s) [37] 4981 0
5041
Recruitment postcode(s) [38] 4982 0
5042
Recruitment postcode(s) [39] 4983 0
5043
Recruitment postcode(s) [40] 4984 0
5044
Recruitment postcode(s) [41] 4985 0
5046
Recruitment postcode(s) [42] 4986 0
5047
Recruitment postcode(s) [43] 4987 0
5048
Recruitment postcode(s) [44] 4988 0
5049
Recruitment postcode(s) [45] 4989 0
5050
Recruitment postcode(s) [46] 4990 0
5030
Recruitment postcode(s) [47] 4991 0
5033
Recruitment postcode(s) [48] 4992 0
5037
Recruitment postcode(s) [49] 4993 0
5045
Recruitment postcode(s) [50] 4994 0
5051

Funding & Sponsors
Funding source category [1] 284670 0
Government body
Name [1] 284670 0
Australian Research Council Linkage Grant
Country [1] 284670 0
Australia
Funding source category [2] 284671 0
Commercial sector/Industry
Name [2] 284671 0
Peanut Company of Australia
Country [2] 284671 0
Australia
Primary sponsor type
Individual
Name
Dr Alison Coates
Address
Nutritional Physiology Research Centre
University of South Australia Frome Road
Adelaide 5001
Australia
Country
Australia
Secondary sponsor category [1] 283576 0
Individual
Name [1] 283576 0
Professor Peter Howe
Address [1] 283576 0
Nutritional Physiology Research Centre
University of South Australia Frome Road
Adelaide 5001
Australia
Country [1] 283576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286674 0
University of South Australia
Ethics committee address [1] 286674 0
Ethics committee country [1] 286674 0
Australia
Date submitted for ethics approval [1] 286674 0
Approval date [1] 286674 0
19/12/2011
Ethics approval number [1] 286674 0
0000024181.

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

Contacts
Principal investigator
Name 33750 0
Ms Jayne Barbour
Address 33750 0
Nutritional Physiology Research Centre University of South Australia Frome Road Adelaide 5001
Country 33750 0
Australia
Phone 33750 0
+61 83022348
Fax 33750 0
Email 33750 0
[email protected]
Contact person for public queries
Name 16997 0
Jayne Barbour
Address 16997 0
Nutritional Physiology Research Centre
University of South Australia Frome Road
Adelaide 5001
Country 16997 0
Australia
Phone 16997 0
+61 8 83022348
Fax 16997 0
Email 16997 0
[email protected]
Contact person for scientific queries
Name 7925 0
Dr Alison Coates
Address 7925 0
Nutritional Physiology Research Centre
University of South Australia Frome Road
Adelaide 5001
Australia
Country 7925 0
Australia
Phone 7925 0
+61 8 83022313
Fax 7925 0
Email 7925 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
EmbaseEffect of 12 weeks high oleic peanut consumption on cardio-metabolic risk factors and body composition.2015https://dx.doi.org/10.3390/nu7095343
EmbaseCerebrovascular and cognitive benefits of high-oleic peanut consumption in healthy overweight middle-aged adults.2017https://dx.doi.org/10.1080/1028415X.2016.1204744
N.B. These documents automatically identified may not have been verified by the study sponsor.