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Trial registered on ANZCTR


Registration number
ACTRN12616000571471
Ethics application status
Approved
Date submitted
29/04/2016
Date registered
3/05/2016
Date last updated
1/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of almond consumption on metabolic and liver function in overweight and obese adults with increased fasting glucose.
Scientific title
Effect of almond consumption on metabolic and liver function in overweight and obese adults with increased fasting glucose.
Secondary ID [1] 289055 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired glucose tolerance 298493 0
cardio-metabolic disease 298494 0
Non-alcoholic fatty liver disease 298495 0
Overweight/obesity 298601 0
Condition category
Condition code
Diet and Nutrition 298579 298579 0 0
Obesity
Metabolic and Endocrine 298580 298580 0 0
Metabolic disorders
Metabolic and Endocrine 298672 298672 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After a 2-week nut and seed washout period participants will consume 56g almonds/day (2 servings/day) consumed alone as whole raw almonds as a morning snack (28g) and afternoon snack (28g) for a period of 8 weeks. Participants will complete an online daily checklist throughout the study to assess compliance to the intervention.
Intervention code [1] 294554 0
Prevention
Intervention code [2] 294628 0
Treatment: Other
Intervention code [3] 294629 0
Lifestyle
Comparator / control treatment
After a 2-week nut and seed washout period participants will consume 72g commercially available isocaloric, sweet (nut/seed free) biscuits/day (2 servings/day) consumed as a morning snack (36g) and afternoon snack (36g) for a period of 8 weeks. Participants will complete an online daily checklist throughout the study to assess compliance to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 298075 0
Dynamic glucose regulation assessed by diurnal glucose variability (GV) and postprandial hyperglycaemia (PPG) from diurnal glucose profiles with data collected using a continuous glucose monitoring device worn for 7-days.
Timepoint [1] 298075 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Primary outcome [2] 298076 0
Liver lipid composition by proton magnetic resonance spectroscopy.
Timepoint [2] 298076 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [1] 323108 0
Serum alanine aminotransferase, (ALT), aspartate aminotransferase (AST) (composite secondary outcome) using Beckman AU480 clinical analyser
Timepoint [1] 323108 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [2] 323110 0
Gut microbiome and bacteria metabolism profile on faecal DNA extracts (composite secondary outcome) by paired-read sequencing using Illumina MiSeq platform
Timepoint [2] 323110 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [3] 323111 0
Gut permeability using the dual sugar intestinal permeability test
Timepoint [3] 323111 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [4] 323112 0
Total body weight and composition (composite secondary outcome) by bioelectric impedance
Timepoint [4] 323112 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [5] 323113 0
Traditional markers of cardiometabolic health including fasting blood glucose, serum total cholesterol, HDL-C, triglycerides and insulin using commercial assay kits
Timepoint [5] 323113 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [6] 323114 0
Systemic inflammatory marker including serum high-sensitive C-reactive protein (hs-CRP) using Beckman Coulter AU480 Chemistry Analyzer; serum interleukin 6 (IL-6) and tumor necrosis factor alpha (TNFa) using Multiplex.
Timepoint [6] 323114 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [7] 323115 0
Blood pressure using an automated blood pressure monitor
Timepoint [7] 323115 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [8] 323329 0
Abdominal fat volume using magnetic resonance imaging.
Timepoint [8] 323329 0
Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention
Secondary outcome [9] 326286 0
Food and nutrient intake using a 3-day weighted food record
Timepoint [9] 326286 0
Prior to commencing the intervention (week 1 of 2 week nut and seed washout period), 7 weeks post commencement of intervention

Eligibility
Key inclusion criteria
1. Male or female
2. Aged 20-70 years
3. The following inclusion criteria were chosen to maximise the probability of a population with abnormal metabolic and liver function:
a. Overweight/obese (BMI: >=27 kg/m2)
b. Waist circumference: > 88 cm for females, >102 cm for males
c. Fasting plasma glucose >=5.6 mmol/L or previously diagnosed type 2 diabetes (T2D) (confirmed by evidence of previous diagnosis and not taking any diabetes medication)
4. Weight stable (i.e. no more than 3 kg weight loss/gain in the past 2 months)
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Smoking
2. Usage of medications/supplements, health conditions (including gastrointestinal disease, kidney disease, liver disease, cardiovascular disease, type 1 diabetes and cancer) and lifestyle factors that may affect the study outcomes or participant’s health at the discretion of the overseeing research physician after review the screening questionnaire.
3. Have type 2 diabetes and currently taking oral hypoglycaemic or insulin medication or have uncontrolled diabetes (indicated by HbA1c >10%)
4. Body weight >~140 kg due to technical difficulties related to the measurement and analysis of MRI scans with participants >~140 kg
5. History of smoking during 6 month prior to the study
6. Known allergies to nuts, dairy, gluten or not willing to consume, test foods
7. History of heavy alcohol consumption (>4 standard drinks/day)
8. Women who are attempting to become pregnant, pregnant, lactating
9. Extended absences due to travel or other commitments
10. On any weight loss program, commercial or self-administered with the goal to lose weight
11. Past history of claustrophobia – to enable body composition assessments to be performed
12. Presence of any ferrous metal in the body - to enable body composition assessments to be performed.


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)
Participants who are eligible will be enrolled in the project and allocated to an intervention code based on a computer generated randomization scheme. Individuals who enrol and allocate participants to interventions will be blind to intervention codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned to the interventions using stratified random assignment based on sex, age and BMI. The randomization scheme will be computer generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
40 participants in each group completing the study will provide 80% power (alpha<0.05) to detect a statistically significant difference of 22% between treatments for diurnal glucose variability and 2% for hepatic lipid content. An additional 10 participants (5 per group) will be recruited to account for ~10% attrition during the study (total sample size = 90)
Main intervention effects will be assessed using mixed effects longitudinal models using IBM SPSS statistics for WINDOWS.

Recruitment
Recruitment status
Recruiting
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
Recruitment postcode(s) [1] 13164 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293436 0
Commercial sector/Industry
Name [1] 293436 0
Almond Board of California
Address [1] 293436 0
1150 Ninth St., Ste. 1500, Modesto, CA95354
Country [1] 293436 0
United States of America
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
South Australian Health and Medical Research Institute building, North Terrace, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 292260 0
None
Name [1] 292260 0
Address [1] 292260 0
Country [1] 292260 0
Other collaborator category [1] 278961 0
University
Name [1] 278961 0
University of Adelaide
Address [1] 278961 0
Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, 5000
Country [1] 278961 0
Australia
Other collaborator category [2] 278962 0
Other
Name [2] 278962 0
South Australia Health and Medical Research Institute
Address [2] 278962 0
North Terrace, Adelaide, South Australia, 5000
Country [2] 278962 0
Australia
Other collaborator category [3] 278963 0
University
Name [3] 278963 0
University of Sydney
Address [3] 278963 0
75 East Street Lidcombe, New South Wales, Australia, 2141
Country [3] 278963 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294883 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 294883 0
GPO Box 2583, Brisbane, Queensland, 4001, Australia
Ethics committee country [1] 294883 0
Australia
Date submitted for ethics approval [1] 294883 0
16/02/2016
Approval date [1] 294883 0
22/03/2016
Ethics approval number [1] 294883 0
04/2016

Summary
Brief summary
To examine the effects of daily almond intake over a period of 8 weeks in overweight and obese individuals with increased risk of metabolic disease on a comprehensive array of novel markers of metabolic health that share complex interrelationships including:
1. Blood glucose regulation throughout the day/night
2. Liver fat concentration and composition
3. Abdominal (including visceral) fat volume
4. Liver function
5. Gut bacteria profile and functionality
7. Body weight and composition
8. Cardiovascular Disease Risk Markers
9. Systemic Inflammatory Markers
The primary hypothesis is that daily almond consumption (56g – consumed as 2 between meal snacks) for 8 weeks will reduce diurnal PPG and GV and hepatic lipid content to a greater extent than an isocaloric control snack.
Secondary hypotheses are that daily almond consumption (56g – consumed as 2 between meal snacks) for 8 weeks will improve measures of liver function, gut microbiome and permeability, systemic inflammation and traditional metabolic health markers (i.e. fasting insulin and glucose, HbA1c and lipids including cholesterol and triglyceride) to a greater extent than an isocaloric control snack.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65318 0
Dr Grant Brinkworth
Address 65318 0
CSIRO
Food and Nutrition, Riverside Corporate Park, 11 Julius Avenue, North Ryde NSW 2113.
Country 65318 0
Australia
Phone 65318 0
+61 2 9490 5665
Fax 65318 0
Email 65318 0
Grant.Brinkworth@csiro.au
Contact person for public queries
Name 65319 0
Dr Jane Bowen
Address 65319 0
CSIRO
PO Box 10041, Adelaide, South Australia, 5000
Country 65319 0
Australia
Phone 65319 0
+61 8 8303 8907
Fax 65319 0
Email 65319 0
jane.bowen@csiro.au
Contact person for scientific queries
Name 65320 0
Dr Grant Brinkworth
Address 65320 0
CSIRO
Food and Nutrition, Riverside Corporate Park, 11 Julius Avenue, North Ryde NSW 2113.
Country 65320 0
Australia
Phone 65320 0
+61 2 9490 5665
Fax 65320 0
Email 65320 0
grant.brinkworth@csiro.au

No information has been provided regarding IPD availability
Summary results
No Results