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Trial registered on ANZCTR


Registration number
ACTRN12615001187538
Ethics application status
Approved
Date submitted
7/10/2015
Date registered
3/11/2015
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Benefits of nuts and seeds in the diets of postmenopausal women with type 2 diabetes.
Scientific title
Do postmenopausal women with type 2 diabetes, consuming nuts or seeds or nuts plus seeds, compared to no nuts or seeds, have an improved lipid and lipo-protein profile
and reduced levels of HbA1c ?
Secondary ID [1] 287567 0
Nil Known
Universal Trial Number (UTN)
U1111-1175-0412
Trial acronym
The NuSeD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 296353 0
Dyslipidaemia 296354 0
Glycaemic control 296355 0
Condition category
Condition code
Diet and Nutrition 296630 296630 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 296741 296741 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention is investigating the effect on blood lipids, lipo-proteins and glycaemic control of adding 30g /day nuts or 30g /day seeds or a combination of nuts and seeds supplying 15g nuts plus 15g seeds to the usual diets of postmenopausal women with type 2 diabetes. This is a randomized parallel study lasting 12 weeks. there are 3 intervention groups.The study will use hazelnuts and sunflower seeds. The nuts and seeds may be consumed at the time best suited to the participant i.e. they have complete choice of time of day or eating occasion with no instructions to eat all at one sitting or as part of a meal. Free choice of time and amount mimics a usual situation and behaviour. The strategies to monitor adherence are supplying nuts and seeds in daily packets of 30g each, with the instruction to return the empty or partially empty packets at the end of each 4 week period when the next set of packaged nuts are collected. The tick sheets are used daily for the participant to record the amount, time, and eating occasion -meal or snack. We have used these strategies with success in previous studies and the recording of daily consumption data is useful for per protocol analysis and to assess preferred times and occasions of consumption and the amount consumed at any one time.
Intervention code [1] 292971 0
Treatment: Other
Intervention code [2] 292972 0
Behaviour
Comparator / control treatment
All participants will be asked to continue with their usual diets in the two weeks leading up to the study start. During this time they will complete the first of the two 3 day weighed diet protocols. At week zero i.e. at the end of this two week period participants will be entered into the study by random allocation carried out by the off site statistician. They will be randomized into either one of the 3 groups nuts or seeds or nuts + seeds or the control group. Thus the control group will be drawn from the same population. They will receive no nuts or seeds and be asked to continue with their usual diets (which may of course include nuts if that is part of their usual eating pattern). At the conclusion of the study the control group participants will be offered a one off amount nuts or seeds or a combination -depending on their choice.
Control group
Active

Outcomes
Primary outcome [1] 296241 0
Change in total cholesterol, assessed using a blood sample

Timepoint [1] 296241 0
Week 0 then week 12
Primary outcome [2] 296242 0
Glycosylated haemoglobin (HbA1c)
HbA1c
Venous blood for measurement is drawn into a tube with the anticoagulant.
K2-EDTA, and measured by enzymatic methods using kits and calibrators
on a Cobas Mira Plus Analyser.
Timepoint [2] 296242 0
Week 0 and week 12
Primary outcome [3] 296243 0
Dietary intake assessed by 3 day weighed diet records.
Timepoint [3] 296243 0
Prior to study commencement at week 0 and between weeks 5-7 of the intervention periods.
Secondary outcome [1] 317951 0
Measurement of physical activity with NL-1000 Pedometers
Timepoint [1] 317951 0
7 day measurements at baseline and between weeks 9-11 of the intervention period
Secondary outcome [2] 317953 0
Appetite-rating questionnaire to record hunger, desire to eat, prospective consumption, fullness and preoccupation with thoughts of food measured on 100 mm visual analogue scales (VAS)-for those in the three intervention groups. The questionnaires have come from the work of Blundell et al. Blundell J1, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M.
Appetite control: methodological aspects of the evaluation of foods.
Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
We have used them in a number of previous studies.
Timepoint [2] 317953 0
Immediately before and after consumption of the study nuts /seeds on the same three days that dietary intake are recorded-for those in the three intervention groups. There are 2 periods when the participants are asked to keep a 3 day weighed diet record (on 2 weekdays & 1 weekend day) these periods are between week 0-2 and weeks 5-7 during the intervention period. The participants may choose which days specifically the 'use' during these time frames. Which ever 3 days they choose are the days on which they are asked to answer the appetite rating questionnaire.
Secondary outcome [3] 317954 0
Rating of acceptance of nuts & seeds. Participants rate “liking” and “desire to consume” the nuts /seeds on 100 mm VAS.
Timepoint [3] 317954 0
Rating weekly during the 12-week intervention period.
Secondary outcome [4] 317955 0
Plasma Alpha tocopherol
Timepoint [4] 317955 0
From blood sample at weeks 0 and 12
Secondary outcome [5] 317956 0
Weight measured on calibrated electronic scales
Timepoint [5] 317956 0
Week 0 and week 12
Secondary outcome [6] 318236 0
waist measurement according to a standard protocol
Timepoint [6] 318236 0
Week 0 and week 12
Secondary outcome [7] 318356 0
Change in LDL cholesterol, assessed using a blood sample. This is a primary outcome.
Timepoint [7] 318356 0
Week 0 and week 12
Secondary outcome [8] 318357 0
Change in HDL cholesterol, assessed using a blood sample. This is a primary outcome.
Timepoint [8] 318357 0
Week 0 and week 12
Secondary outcome [9] 318358 0
Change in Apo B100, assessed using a blood sample. This is a primary outcome.
Timepoint [9] 318358 0
Week 0 and week 12
Secondary outcome [10] 318359 0
Change in ApoA1, assessed using a blood sample. This is a primary outcome.
Timepoint [10] 318359 0
Week 0 and week 12
Secondary outcome [11] 318360 0
Change in triglycerides, assessed using a blood sample. This is a primary outcome.
Timepoint [11] 318360 0
Week 0 and week 12

Eligibility
Key inclusion criteria
Type 2 Diabetes Mellitus; post menopausal status; able to comply with the study protocol and to consume nuts and seeds;
general good health; no food related allergies.
Minimum age
35 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Neither Type 2 Diabetes Mellitus, post menopausal status nor able to comply with the study protocol. Food related allergies especially to nuts.

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)
Allocation will be carried out by contacting the holder of the allocation schedule who is off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power Calculations: In order to have 80% power to detect moderate differences (0.5 SD) in outcomes between any two arms of the study (which would be equivalent to approximately 0.15 mmol/l for HDL, 0.35 mmol/L for triglycerides, 0.7% or 8mmol/mol for HbA1c, 1.75mmol/l for fasting glucose, and 0.1 g/L for apo A1 and B100) using two-sided tests at the 0.05 level, assuming correlations of 0.5 or higher between baseline and follow-up values, 48 participants would be required for each arm of the study. In order to allow for 10% lost data due to loss to follow-up or unusable measurements, 220 participants should be enrolled at baseline (55/group).
Statistical Analysis: Baseline characteristics will be presented using appropriate summary statistics. The effects of the three interventions will be examined using linear regression models, controlling for baseline values. The main analysis will be performed using modified intention to treat principles (using all available data) but per protocol analyses are also planned. Standard model diagnostics will be used to assess model fit. Stata 13.1 or a later version will be used for all analyses. All tests will be performed at the two-sided 0.05 level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7213 0
New Zealand
State/province [1] 7213 0
Otago

Funding & Sponsors
Funding source category [1] 292184 0
Government body
Name [1] 292184 0
Lotteries Health Research
Address [1] 292184 0
Department of Internal Affairs
46 Waring Taylor Street
Wellington 6011
P.O. Box 805
Wellington 6140
Country [1] 292184 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street
Dunedin 9016
P.O. Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 290861 0
None
Name [1] 290861 0
Address [1] 290861 0
Country [1] 290861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293657 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 293657 0
Ministry of Health
Ethics Department
Reception-Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 293657 0
New Zealand
Date submitted for ethics approval [1] 293657 0
05/04/2016
Approval date [1] 293657 0
08/04/2016
Ethics approval number [1] 293657 0
15/STH/237

Summary
Brief summary
The question we are investigating is whether adding 30g/d nuts, 30g/d seeds or a combination of both, rich in healthy monounsaturated and polyunsaturated fats, will result in beneficial changes in blood lipid and lipoprotein risk factors related to CVD and whether there will also be an improvement in glycaemic control. This is a study in the community- where women, in the post menopause, with type 2 diabetes will incorporate the nuts and seeds into their usual diets, as part of a meal or as a snack. The participants may also decide whether to consume the daily amount at one eating occasion or divide them during the day, as long as the daily portion is consumed within 24 hours. Consummation times will be at the participants discretion they can decide to consume the nuts and seeds with a meal, as a snack, or divided between between both. Participants will also record on ‘tick sheets’ the time the nuts / seeds were consumed and if alone or with other foods. Tick sheets have been used with success in many previous study. The sheets are supplied with a table for each day where the participants can record the time of day and how the snack was consumed, there will also be a space for comments. The sheets will be returned with the nut or seeds bags when the next 4 weeks allocation is collected. Thus we are also investigating the acceptance of eating nuts regularly and whether this intervention is effective regardless of the background diet, and time of consumption. There will be a control group who will continue with their usual diets. This is to ascertain whether the changes seen are as a result of the intervention and would not just have happened anyway, during the period of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60682 0
Dr Alexandra Chisholm
Address 60682 0
Department of Human Nutrition University of Otago P.O. Box 56 Dunedin 9054
Country 60682 0
New Zealand
Phone 60682 0
+ 64 3 479 7514
Fax 60682 0
+ 64 3 479 7958
Email 60682 0
alex.chisholm@otago.ac.nz
Contact person for public queries
Name 60683 0
Dr Alexandra Chisholm
Address 60683 0
Department of Human Nutrition University of Otago P.O. Box 56 Dunedin 9054
Country 60683 0
New Zealand
Phone 60683 0
+ 64 3 479 7514
Fax 60683 0
+ 64 3 479 7958
Email 60683 0
alex.chisholm@otago.ac.nz
Contact person for scientific queries
Name 60684 0
Dr Alexandra Chisholm
Address 60684 0
Department of Human Nutrition University of Otago P.O. Box 56 Dunedin 9054
Country 60684 0
New Zealand
Phone 60684 0
+ 64 3 479 7514
Fax 60684 0
+ 64 3 479 7958
Email 60684 0
alex.chisholm@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
only a smaller sample size than calculated to be needed was able to be recruited
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?
No
Results – basic reporting
Results – plain English summary