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Trial registered on ANZCTR


Registration number
ACTRN12618001758291
Ethics application status
Approved
Date submitted
15/10/2018
Date registered
25/10/2018
Date last updated
25/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Snacking @ Otago Study: The effects of consuming almonds or biscuits on body weight and satiety
Scientific title
The Snacking @ Otago Study: The effects of consuming almonds or biscuits on body weight and satiety in healthy volunteers
Secondary ID [1] 295571 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body weight 308844 0
Satiety 310120 0
Condition category
Condition code
Diet and Nutrition 307777 307777 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 308871 308871 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will examine the acute and long-term effects of consuming almonds and biscuits on body weight management and satiety among people who regularly snack on discretionary foods.
This study has two components - an acute phase and a long-term study.

The long-term phase assess the effects is a one-year randomised parallel study with 2 arms:
Arm 1: Almonds (participants will receive 42.5 grams per day (g/d) or 10% of energy (whichever is more) of raw and dry roasted almonds. They will be asked to eat the study foods as snacks throughout the day.

Arm 2: Biscuits (will provide the same energy as the almond)

Compliance during the long-term study will be measured by food diaries, return and weighing of snack bags and uneaten snacks, and plasma vitamin E concentrations will also be assessed as a measure of compliance to consuming the almonds.

The acute phase will assess the effects of consuming raw almonds (42.5 g/d or 10% of energy (whichever is more)) or biscuits ( same energy as almonds) on blood glucose response and satiety. This will be a crossover design where participants will receive the treatments in random order. Participants will attend two clinic visits of around 5 hours, with a one week washout between treatments. Participants will attend the clinic after fasting for at least 8-10 hours. They will be provided with a standardised breakfast comprising of 20% of their total energy requirements. The breakfast will consist of ready-to-eat muesli (Toasted Muesli Golden Oats and Fruit; Sanitarium, Auckland, Christchurch, New Zealand), fruit-flavoured non-fat yoghurt (Fresh’n Fruity Wildly Berry yoghurt; Fonterra Brands Ltd, Auckland, New Zealand) and 3.3%-fat milk (Meadow Fresh Standard Milk; Goodman Fielder, Auckland, New Zealand), and provide, on average, 53% energy from carbohydrate, 14% energy from protein and 30% energy from fat. Two hours after the breakfast they will be provided with the almond or biscuit snack. They will be asked to consume this within 10 minutes. Before they consume the snack, and at intervals of 15, 30, 45, 60, 90 and 120 minutes following snack consumption, we will take a fingerpick blood sample for measurement of blood glucose. Participants will also record hunger and satiety ratings at these time points using 100 mm visual analogue scales. Two hours following snack consumption, participants will consume an ad libitum lunch. They will be offered sandwiches and will be asked to eat until they are comfortably full over 20 minutes. Participants will complete a weighed food diary for the remainder of the day.

The acute phase and long term study will be separated by at least two weeks. There will be a 2-week no-nut run-in prior to the start of the long-term intervention.
Intervention code [1] 312633 0
Lifestyle
Intervention code [2] 312680 0
Treatment: Other
Comparator / control treatment
The comparison group will receive biscuits (equal to the same energy content as the almonds)
Control group
Active

Outcomes
Primary outcome [1] 307738 0
Body weight will be measured using Tanita scales
Timepoint [1] 307738 0
Body weight will be measured at baseline, 3 months 6 months and 12 months [primary timepoint]
Primary outcome [2] 307880 0
Satiety will be measured using 100 mm visual analogue scales. This will include questions on hunger, desire to eat, prospective consumption, fullness, and preoccupation with thoughts of food. Hunger will be assessed with the question “How hungry do you feel right now?” preceded with a 100 mm VAS, anchored with “Not at all hungry” on the left side (0 mm) to “Extremely hungry” on the right side of the scale (100 mm). Desire to eat will be assessed with the question, “How strong is your desire to eat right now?” and anchored with “Strong desire not to eat” and “Strong desire to eat.” Prospective consumption will be assessed with the question, “How much food could you eat right now?” and anchored with “Nothing at all” and “The most that I have ever eaten.” Fullness will be assessed with the question, “How full do you feel right now?” and anchored with “Not at all full” and “Extremely full.” Preoccupation with thoughts of food will be assessed with the question “Do you have any preoccupation with thoughts of food right now?” and anchored with “No thoughts of food” and “Very preoccupied, difficult to concentrate”. These outcomes are part of a composite primary outcome.
Timepoint [2] 307880 0
Satiety will be measured in both the acute and long-term components of the study. For the acute part of the study, satiety will be measured at the baseline and 15, 30. 45. 60. 90, and 120 minutes following nut or almond consumption. This will be followed by an ad libitum lunch.
For the long-term study, satiety will be measured as part of the three-day diet records which will be completed at 3, 6 and 12 months.
Secondary outcome [1] 352733 0
Blood lipids. lipoproteins, and apolipoproteins will be a composite outcome comprising of total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglycerides (TAG), apolipoprotein A1 (apo A1) and apolipoprotein B100 (apo B).
TC, HDL-C, and TAG will be measured by enzymatic methods using a Cobas Mira Plus analyser (Roche). Plasma low density lipoprotein cholesterol will be calculated by the Friedewald equation. Plasma apolipoprotein A1 and B100 concentrations will be determined by immunoturbidity using commercial kits from Roche Diagnostics (Mannheim, Germany).
Timepoint [1] 352733 0
Blood lipids, lipoproteins and apolipoproteins will be measured at baseline, 3 months 6 months and 12 months
Secondary outcome [2] 352735 0
Resting metabolic rate (RMR) will be measured using indirect calorimetry based on best practice methods outlined by Compher et al. RMR will be measured with the participant lying in the supine position in a quiet dark room for thirty minutes. Throughout this period expired air samples (Cortex metalyser 11) will be collected to allow for a steady state to occur. A valid RMR will be obtained when a minimum of 15 min of steady state has occurred (fluctuations in oxygen consumption <10% and the respiratory quotient varies by less than 5%). Oxygen consumption and carbon dioxide production will be used to calculate RMR.
Timepoint [2] 352735 0
Resting metabolic rate will be measured at baseline and 12 months
Secondary outcome [3] 352736 0
Dietary intake will be measured using 3-day weighed food diaries.
Timepoint [3] 352736 0
Dietary intake will be measured at baseline, 3, 6, and 12 months
Secondary outcome [4] 352737 0
The SphygmoCor 2000 (AtCor Medical Pty Ltd, Sydney, Australia) will be used to measure brachial, systolic and diastolic blood pressure.
Timepoint [4] 352737 0
Blood pressure will be measured at baseline, 3, 6, and 12 months.
Secondary outcome [5] 352738 0
The SphygmoCor 2000 will also be used to measure carotid-femoral pulse wave-velocity (PWV). Participants will be lying in the supine position for five minutes before measurements are collected.
Timepoint [5] 352738 0
Pulse wave velocity will be measured at baseline and 12 months
Secondary outcome [6] 352739 0
High-sensitivity C-reactive protein will be measured as markers of Inflammation. For the measurement of hsCRP we will use a CRP Unimate kit from Roche Diagnostics on a Cobas Mira Plus Analyser (Roche).
Timepoint [6] 352739 0
CRP will be measured at baseline, 3, 6, and 12 months
Secondary outcome [7] 352740 0
Body Composition will be measure by dual energy x-ray absorptiometry (DXA, GE Lunar Prodigy, GE Healthcare, Madison, WI), with visceral fat volume estimated using the Lunar Encore software CoreScan (Version 16, GE Healthcare, General Electric Company, Chicago, IL). Total fat and estimated visceral fat will be assessed.
Timepoint [7] 352740 0
Body composition will be measured at baseline and 12 months
Secondary outcome [8] 352741 0
Endothelial function will be measured by measuring intercellular adhesion molecule 1 (ICAM-1). ICAM-1, will be measured by using a Quantikine ELISA Kits (R&D Systems) following the instructions of the manufacturer.
Timepoint [8] 352741 0
ICAM-1 will be measured at baseline, 3, 6, and 12 months
Secondary outcome [9] 352742 0
Glycated haemoglobin (HbA1c) will be measured by an enzymatic method on a Cobas Mira Plus Analyzer (Roche Diagnostics, Indianapolis, Indiana).
Timepoint [9] 352742 0
Glycated Haemoglobin will be measured at baseline, 3, 6, and 12 months
Secondary outcome [10] 352743 0
Vitamin E will be determined using the Agilent high-performance liquid chromatography system (1100 series, Agilent Technologies Inc., Santa Clara, Ca, USA).
Timepoint [10] 352743 0
Vitamin E will be measured at baseline, 3, 6, and 12 months
Secondary outcome [11] 352744 0
Adiponectin will be measured by ELISA.
Timepoint [11] 352744 0
Adiponectin will be measured at baseline, 3, 6, and 12 months
Secondary outcome [12] 352745 0
Leptin will be measured by ELISA.
Timepoint [12] 352745 0
Leptin will be measured at baseline, 3, 6, and 12 months
Secondary outcome [13] 352746 0
Hedonic (“liking”) ratings of the almonds and the biscuits will be measured on 100 mm visual analogue scales at weekly intervals during the intervention.
Timepoint [13] 352746 0
Consumer acceptance will be measured at weekly intervals for 12 months post-baseline.
Secondary outcome [14] 352953 0
Eating behaviour will be assessed at baseline and the end of the intervention using Intuitive Eating Questionnaire-2.
Timepoint [14] 352953 0
Eating behaviour will be measured at baseline and 12 months
Secondary outcome [15] 352954 0
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [15] 352954 0
This will be measured at baseline and during the intervention at 3, 6, and 12 months.
Secondary outcome [16] 353197 0
Interleukin-6 will be measured as a marker of Inflammation. IL-6, will be measured by using a Quantikine ELISA Kits (R&D Systems) following the instructions of the manufacturer.
Timepoint [16] 353197 0
Baseline, 3, 6 and 12 months
Secondary outcome [17] 353201 0
Wanting (“desire to consume”) ratings of the almonds and the biscuits will be measured on 100 mm visual analogue scales at weekly intervals during the intervention. Participants will be asked to take a bite of the nut/biscuit and rate their “desire to consume” on a 100-mm VAS, anchored with “strong desire not to consume” on the left side (0 mm) to “strong desire to consume” on the right side (100 mm).
Timepoint [17] 353201 0
Consumer acceptance will be measured at weekly intervals for 12 months post-baseline.
Secondary outcome [18] 353202 0
Eating behaviour will be assessed at baseline and the end of the intervention using The Dutch Eating Behaviour Questionnaire (DEBQ).
Timepoint [18] 353202 0
Eating behaviour will be measured at baseline and 12 months.
Secondary outcome [19] 353206 0
Endothelial function will be measured by measuring vascular cell adhesion molecule (VCAM) . VCAM-1 will be measured by using a Quantikine ELISA Kits (R&D Systems) following the instructions of the manufacturer.
Timepoint [19] 353206 0
VCAM-1 will be measured at baseline, 3, 6, and 12 months

Eligibility
Key inclusion criteria
•Healthy people (no restrictions on sex, gender, or ethnicity) aged 18-65 years
•BMI >18.49 and < 30 kg/m2 and
•People who are regular snackers on discretionary foods (consuming at least 1.5 times the minimum energy content of the almonds/biscuits to be provided by the study, which is around 1500 kJ/d)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• People with a BMI greater than 30 kg/m2 or less than 18.5 kg/m2
• People with food allergies or intolerances to nuts
• Those who have coeliac disease or an intolerance to wheat
• People with dentition issues that would prevent them from consuming whole nuts
• Those taking dietary supplements e.g. vitamin E
• Smokers
• People with a chronic disease such as heart disease, diabetes or cancer
• Pregnant and lactating women
Intolerant or allergic to dairy

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)
Allocation concealment will be used for the long-term and acute study. This will be achieved through allocation being performed by a researcher who will have no involvement in the enrolment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For the long-term study Minimisation will be used.

For the acute study simple randomisation will be performed using a randomisation table
created by 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
Other
Other design features
The acute phase will be a crossover design.
The long-term study will be a parallel study design.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The effects of the two interventions on all outcomes will be examined using linear mixed models to include both baseline and follow-up values, estimating within-group changes for each group alongside the key between-group differences in changes while allowing for non-informative missing follow-up data (given the covariates in the model). Standard model diagnostics will be performed. The primary analysis will be modified intention to treat (using all available data) to assess the pragmatic effects of promoting nut consumption with secondary per protocol analyses. Stata 15.1 (StataCorp, College Station, Tex, USA) will be used and two-sided p<0.05 will be considered significant.

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 20913 0
New Zealand
State/province [1] 20913 0
Otago

Funding & Sponsors
Funding source category [1] 300147 0
Other
Name [1] 300147 0
Almond Board of California
Address [1] 300147 0
1150 9th Street #1500, Modesto, CA 95354, USA
Country [1] 300147 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56
Dunedin, 9054
Country: New Zealand
Country
New Zealand
Secondary sponsor category [1] 299550 0
None
Name [1] 299550 0
Address [1] 299550 0
Country [1] 299550 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300979 0
University of Otago Ethics Committee (Health)
Ethics committee address [1] 300979 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 300979 0
New Zealand
Date submitted for ethics approval [1] 300979 0
09/07/2018
Approval date [1] 300979 0
03/10/2018
Ethics approval number [1] 300979 0
H18/109

Summary
Brief summary
The objective of this study is to examine the long-term effects of consuming almonds on body weight management and satiety among people who regularly snack on discretionary foods. To this end, the primary aim of this study is to compare the effects of consuming whole almonds (either 42.5 g/d or 10% of total energy requirement (TER) (whichever is the highest value)), with biscuits (as a comparison snack providing the same energy content) on body weight, and satiety, and markers of overall health among healthy adults over a 12-month period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85498 0
A/Prof Rachel Brown
Address 85498 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 85498 0
New Zealand
Phone 85498 0
+64 3 4795839
Fax 85498 0
Email 85498 0
rachel.brown@otago.ac.nz
Contact person for public queries
Name 85499 0
A/Prof Rachel Brown
Address 85499 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 85499 0
New Zealand
Phone 85499 0
+64 3 4795839
Fax 85499 0
Email 85499 0
rachel.brown@otago.ac.nz
Contact person for scientific queries
Name 85500 0
A/Prof Rachel Brown
Address 85500 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 85500 0
New Zealand
Phone 85500 0
+64 3 4795839
Fax 85500 0
Email 85500 0
rachel.brown@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable