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Trial registered on ANZCTR


Registration number
ACTRN12615001294549
Ethics application status
Approved
Date submitted
16/11/2015
Date registered
27/11/2015
Date last updated
5/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does 12 weeks of eating different snack foods improve cognitive performance and cardiometabolic health in adults?
Scientific title
Does 12 weeks of eating a habitual diet including almonds, compared with a habitual nut-free diet, affect cognitive performance and cardiometabolic health in healthy overweight adults?
Secondary ID [1] 287454 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 296198 0
Vascular function 296556 0
Cardiometabolic health 296558 0
Condition category
Condition code
Cardiovascular 296472 296472 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 296473 296473 0 0
Other diet and nutrition disorders
Mental Health 296474 296474 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week randomized, controlled, parallel-arm study that investigates the effects of daily unsalted almond consumption on cognitive function and established and emerging cardiometabolic biomarkers of disease in healthy participants in a free-living environment. Participants will be randomly allocated to consuming unsalted almonds (at 15% of energy intake) in conjunction with their habitual diet for 12 weeks. Overall calorie intake will remain the same as their habitual diet so participants will be advised by a dietitian on how to substitute foods to maintain the equivalent energy intake. Test foods can be eaten at any time of the day as decided by the participant. Test food checklists, serum and erythrocyte alpha-tocopherol (Vitamin E) levels will used to assess compliance.
Intervention code [1] 292844 0
Lifestyle
Comparator / control treatment
12-week randomized, controlled, parallel-arm study that investigates the effects of daily unsalted almond consumption on cognitive function and established and emerging cardiometabolic biomarkers of disease in healthy participants in a free-living environment. Participants will be randomly allocated to consuming an isocaloric snack food (at 15% of energy intake) in conjunction with their habitual diet for 12 weeks. The control snack foods will contain an equal amount of energy and will be provided by the study. Participants' overall calorie intake will remain the same as their habitual diet so participants will be advised by a Dietitian on how to substitute foods to maintain the equivalent energy intake. Test food checklists will used to assess compliance. Participants will be advised to avoid nuts, including nuts as snacks, ingredients in a recipe (either as whole or ground nuts) or in packaged products more than or equal to 5% nuts as listed in the ingredients. All participants will have a 2 week period prior to stating the trial where they do not eat nuts or nut products.
Control group
Active

Outcomes
Primary outcome [1] 296106 0
Change in the the composite scores for the cognitive domain, Attention, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups. The Attention domain will be assessed by the following tasks : Simple Reaction Time, Choice Reaction Time, Four-Choice Reaction Time, Rapid Visual Information Processing (RVIP) task and Serial Subtractions.
Timepoint [1] 296106 0
Baseline and after completion of 12 weeks dietary intervention
Primary outcome [2] 296719 0
Change in the the composite scores for the cognitive domain, Working Memory, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups. Participants' Working Memory will be assessed by the following tasks : Numerical Working Memory, N-back, Corsi blocks, Serial Subtraction and Rapid Visual Information Processing.
Timepoint [2] 296719 0
Baseline and after completion of 12 weeks dietary intervention
Primary outcome [3] 296720 0
Change in the the composite scores for the cognitive domain, Long term Memory, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups. Participants' Long Term Memory will be assessed by the following tasks : Word Recall, Word Recognition, Picture Recognition and Verbal Fluency.
Timepoint [3] 296720 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [1] 317523 0
Change in body weight/composition (% fat), waist circumference and body mass index from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [1] 317523 0
Baseline and after completion of 12 weeks dietary intervention
Secondary outcome [2] 318404 0
Change in glucose metabolism; fasting plasma glucose and insulin from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [2] 318404 0
Baseline and after completion of 12 weeks dietary intervention
Secondary outcome [3] 318405 0
Change in lipid metabolism; fasting blood lipids (Cholesterol, HDL, triglycerides) from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [3] 318405 0
Baseline and after completion of 12 weeks dietary intervention
Secondary outcome [4] 318406 0
Change in vascular measures; supine blood pressure and arterial compliance of large and small arteries from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [4] 318406 0
Baseline and after completion of 12 weeks dietary intervention
Secondary outcome [5] 318407 0
Change in serum levels of the inflammatory marker; plasma C-reactive protein, from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [5] 318407 0
Baseline and after completion of 12 weeks dietary intervention
Secondary outcome [6] 318408 0
Change in urinary markers of oxidative stress and blood a-tocopherol as a measure of compliance to eating almonds from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet. ..
Timepoint [6] 318408 0
Baseline and after completion of 12 weeks dietary intervention
Secondary outcome [7] 319175 0
Primary Outcome: Change in the the composite scores for the cognitive domain, Executive Function, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups. The Executive Function domain will be assessed by the following tasks: Stroop, Verbal Fluency, Serial Subtraction and Peg and Ball.
Timepoint [7] 319175 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [8] 319176 0
Primary Outcome: Change in the the scores for the cognitive test, Numerical Working Memory, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [8] 319176 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [9] 319177 0
Primary Outcome: Change in the the scores for the cognitive test, Immediate Word Recall, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [9] 319177 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [10] 319178 0
Primary Outcome: Change in the the scores for the cognitive test, Simple Reaction Time, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [10] 319178 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [11] 319179 0
Primary Outcome: Change in the the scores for the cognitive test, Choice reaction Time, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [11] 319179 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [12] 319180 0
Primary Outcome: Change in the the scores for the cognitive test, Four Choice Reaction Time, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [12] 319180 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [13] 319181 0
Primary Outcome: Change in the the scores for the cognitive test, Rapid Visual Information Processing task, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [13] 319181 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [14] 319182 0
Primary Outcome: Change in the the scores for the cognitive test, N-back, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [14] 319182 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [15] 319183 0
Primary Outcome: Change in the the scores for the cognitive test, Corsi Blocks, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [15] 319183 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [16] 319184 0
Primary Outcome: Change in the the scores for the cognitive test, Delayed Word Recall, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [16] 319184 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [17] 319185 0
Primary Outcome: Change in the the scores for the cognitive test, Delayed Word Recognition, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [17] 319185 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [18] 319186 0
Primary Outcome: Change in the the scores for the cognitive test, Delayed Picture Recognition, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [18] 319186 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [19] 319187 0
Primary Outcome: Change in the the scores for the cognitive test, Serial Subtractions, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [19] 319187 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [20] 319188 0
Primary Outcome: Change in the the scores for the cognitive test, Verbal Fluency, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [20] 319188 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [21] 319189 0
Primary Outcome: Change in the the scores for the cognitive test, Excluded Letter Task, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [21] 319189 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [22] 319190 0
Primary Outcome: Change in the the scores for the cognitive test, Stroop, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [22] 319190 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [23] 319191 0
Primary Outcome: Change in the the scores for the cognitive test, Peg and Ball, from baseline to the end of the dietary phase in each group will be assessed and the change scores compared between groups.
Timepoint [23] 319191 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [24] 319192 0
Change in the serum levels of the protein, Vascular Cell Adhesion Molecule, from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [24] 319192 0
Baseline and at the completion of 12 weeks dietary intervention
Secondary outcome [25] 319193 0
Change in the serum levels of the protein, Intrercellular Cell Adhesion Molecule, from baseline to the end of 12 weeks of either consuming a habitual diet with almonds incorporated or 12 weeks of a habitual nut-free diet.
Timepoint [25] 319193 0
Baseline and at the completion of 12 weeks dietary intervention

Eligibility
Key inclusion criteria
Overweight healthy adults with BMI between 25-39.9 kg/m2. Non-smokers.
Weight stable in the past 3 months. No diagnosis of cognitive impairment or memory loss or a Montreal Cognitive Assessment (MoCA) score of >18. Non-restrained eaters. No allergies or food intolerances to nuts or ingredients in control foods.
Minimum age
50 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have a BP of > 160/100 mmHg. Regularly consume large amounts of nuts or nut butters (more than 210 g per week). Have cardiovascular disease (including uncontrolled high blood pressure) and chronic diseases including Type 1 and 2 diabetes. Has a history of depression in the prior 2 years or Geriatric Depression Score (GDS)-15 score of more than 10. Has any neurological disorder, including but not limited to, Alzheimer’s disease, Parkinson’s disease, stroke, intracranial haemorrhage and brain lesions including tumours. Has a recent history (within 12 months) or strong potential for alcohol abuse. Defined as >14 standard drinks per week. Are colour blind. Have changed medications in the last 3 months. Take medications or supplements that may have an impact on the study outcomes. Have a history of infective or inflammatory brain disease or head injury. Are planning on dieting to control weight during the study. Are already involved in a research study that may influence the outcomes of this study within 30 days of commencing present study. Are pregnant or breast feeding.

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 to a treatment arm. An independent holder of the randomisation schedule will perform treatment allocation without contact with the volunteers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Groups will be allocated to treatment using the process of randomization by minimization to ensure matching based on age, gender and body mass index.
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
Baseline characteristics between the treatment groups will be compared using one-way ANOVA. The effects of almonds and control foods on the dependent measures over time will be analyzed using random effects mixed models, with treatment (almond group or control group) and time being the factors in the analysis and time being the repeated measurement. For significant interactions, Bonferroni post hoc pairwise comparisons will be performed to identify differences between means. Statistical significance will be set at P<0.05. Primary outcomes for this trial include composite scores for different cognitive domains and also individual cognitive tests. The composite score of speed of memory is known to decline with age and was susceptible to an omega-3 intervention in a healthy cohort. Additionally, the domain of speed of memory incorporates elements of processing speed which was improved by a nut intervention in a previous study by the team. Power analysis indicated that a total of 68 participants per group will be required to detect a difference in cognitive function between the two groups that equates to a medium effect size (0.5), at an -level of 0.05 with a statistical power of 0.80. An additional 7 subjects per group (10%) will be recruited to allow for attrition. Hence, we will recruit 150 participants in total. Based on previous published studies with similar populations and other nuts, we anticipate having sufficient power for secondary outcomes also.

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 in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292043 0
Commercial sector/Industry
Name [1] 292043 0
The Almond Board of California
Address [1] 292043 0
1150 Ninth St
Suite 1500
Modesto, CA, 95354
Country [1] 292043 0
United States of America
Primary sponsor type
Individual
Name
Assoc.Prof Alison Coates
Address
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
Postal address: GPO Box 2471, Adelaide SOUTH AUSTRALIA 5001.
Country
Australia
Secondary sponsor category [1] 290886 0
Individual
Name [1] 290886 0
Prof. Jon Buckley
Address [1] 290886 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
Postal address: GPO Box 2471, Adelaide SOUTH AUSTRALIA 5001.
Country [1] 290886 0
Australia
Secondary sponsor category [2] 290940 0
Individual
Name [2] 290940 0
Prof. Andrew Scholey
Address [2] 290940 0
Centre for Human Psychopharmacology
Swinburne University
Melbourne VIC 3122
Australia

Country [2] 290940 0
Australia
Secondary sponsor category [3] 290941 0
Individual
Name [3] 290941 0
Dr Alison Hill
Address [3] 290941 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
Postal address: GPO Box 2471, Adelaide SOUTH AUSTRALIA 5001.
Country [3] 290941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293510 0
University of South Australia Human Ethics Committee
Ethics committee address [1] 293510 0
Research and Innovation Services
Mawson Lakes Campus
University of South Australia
PO Box 2471
Adelaide,
South Australia 5001
Australia.
Ethics committee country [1] 293510 0
Australia
Date submitted for ethics approval [1] 293510 0
09/06/2015
Approval date [1] 293510 0
08/10/2015
Ethics approval number [1] 293510 0
0000034452

Summary
Brief summary
The primary aim of this study is to investigate the effects of eating unsalted almonds on major cognitive domains (attention/concentration, executive function, working memory, secondary memory, spatial memory) and the secondary aims are to explore potential cardiovascular, metabolic and inflammatory mechanisms underpinning cognitive enhancement following 12 weeks of almond consumption.This study will be a 12 week
randomized, controlled, parallel arm study that investigates the effects of unsalted almond consumption or alternative snack food (at 15% of energy intake) on cognitive function and established and emerging cardiometabolic biomarkers of disease in healthy participants in a free living environment. Participants will be asked to continue with their usual lifestyle whilst avoiding consumption of other nuts or nut butters apart from study foods. At the start of the study and after 12 weeks of eating almonds or the alternate snack food we will examine cognitive function in a computerised cognitive test battery, as well as cardiometabolic biomarkers (lipids, glucose regulation), vascular function (blood pressure, arterial compliance, circulating adhesion molecules) and markers of systemic inflammation.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 60174 0
A/Prof Alison Coates
Address 60174 0
University of South Australia
School of Health Sciences
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
Postal address: GPO Box 2471, Adelaide SOUTH AUSTRALIA 5001.
Country 60174 0
Australia
Phone 60174 0
+61 8 83022313
Fax 60174 0
Email 60174 0
alison.coates@unisa.edu.au
Contact person for public queries
Name 60175 0
Dr Catherine Yandell
Address 60175 0
University of South Australia
School of Health Sciences
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
Postal address: GPO Box 2471, Adelaide SOUTH AUSTRALIA 5001.
Country 60175 0
Australia
Phone 60175 0
+61 8 83022109
Fax 60175 0
Email 60175 0
catherine.yandell@unisa.edu.au
Contact person for scientific queries
Name 60176 0
A/Prof Alison Coates
Address 60176 0
University of South Australia
School of Health Sciences
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
Postal address: GPO Box 2471, Adelaide SOUTH AUSTRALIA 5001.
Country 60176 0
Australia
Phone 60176 0
+61 8 83022313
Fax 60176 0
Email 60176 0
alison.coates@unisa.edu.au

No information has been provided regarding IPD availability
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