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Trial registered on ANZCTR


Registration number
ACTRN12618001861246
Ethics application status
Approved
Date submitted
1/11/2018
Date registered
15/11/2018
Date last updated
20/11/2018
Date data sharing statement initially provided
15/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of snacking on promoting weight loss and protecting against weight regain in overweight and obese adults.
Scientific title
Does inclusion of almonds in an energy restricted diet enhance weight loss and protect against weight regain in overweight and obese adults?
Secondary ID [1] 296169 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 309792 0
Cardiometabolic health 309797 0
Gut health 309896 0
Condition category
Condition code
Cardiovascular 308586 308586 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 308587 308587 0 0
Obesity
Metabolic and Endocrine 308588 308588 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 9 month randomized, controlled parallel arm dietary intervention comprising a 3 month
energy restriction phase (approximately ~30% energy deficit to induce weight loss) followed by a 6 month weight
maintenance phase (energy requirements calculated on an individual basis based on energy needs to maintain their 3-month time point weight). Participants' diets will include almonds (as 15% of their overall energy requirements) during both the 3 months of energy restricted weight loss and the following 6 months of weight maintenance. The intervention group will incorporate almonds as a snack 6 days/week during both weight loss and weight maintenance. This study will be undertaken with overweight/obese, but otherwise healthy, participants in a free-living environment. Intensive dietary counselling will be provided, during weight loss (individual appointments every 2 weeks) and less intensive counselling during weight maintenance (group sessions every 2 weeks for the first month and then monthly). Participants will be provided with daily checklists with recommended intakes of a variety of foods for meeting their restricted energy requirements. In addition, adherence to diet during the energy restriction phase and weight maintenance periods will be assessed by participants recording food-diaries, 24-hour diet recalls and the daily checklists. Almond consumption will be monitored by almond return and count and daily checklists.
Intervention code [1] 312500 0
Lifestyle
Intervention code [2] 312849 0
Treatment: Other
Comparator / control treatment
A 9 month randomized, controlled parallel arm dietary intervention comprising a 3 month
energy restriction phase (approximately ~30% energy deficit to induce weight loss) followed by a 6 month weight
maintenance phase (energy requirements calculated on an individual basis based on energy needs to maintain their 3-month time point weight). Participants' diets will include carbohydrate-rich foods (as 15% of their overall energy requirements) during both the 3 months of energy restricted weight loss and the following 6 months of weight maintenance. The control group will be nut-free and incorporate carbohydrate-rich foods (such as pretzels, rice crackers, oven-baked fruit cereal bars) as a snack 6 days/week during both weight loss and weight maintenance. This study will be undertaken with overweight/obese, but otherwise healthy, participants in a free-living environment. Intensive dietary counselling will be provided during weight loss (individual appointments every 2 weeks) and less intensive counselling during weight maintenance (group sessions every 2 weeks for the first month and then monthly). Participants will be provided with daily checklists with recommended intakes of a variety of foods for meeting their restricted energy requirements. In addition, adherence to diet during the energy restriction phase and weight maintenance periods will be assessed by participants recording in food-diaries, 24-hour diet recalls and with daily checklists. Snack food consumption will be monitored by snack food return and count and daily checklists.
Control group
Active

Outcomes
Primary outcome [1] 307556 0
Body weight in kg (to one decimal point) using scales.
Timepoint [1] 307556 0
0, 3 (primary endpoint) and 9 months post-enrolment
Primary outcome [2] 308066 0
Appetite regulation
2 hours after the consumption of a test snack of either almonds or baked fruit-filled cereal bar (control) participants will be presented with a buffet meal. The buffet meal will be free of nuts and will provide a selection of core and non-core foods and beverages for participants to select from. All foods eaten at the buffet will be monitored and energy and diet-quality of the meal consumed assessed using nutritional analysis software.
Timepoint [2] 308066 0
0, 3 (primary endpoint) and 9 months post-enrolment
Secondary outcome [1] 352287 0
Total body fat mass (%, kg) will be determined from a whole body DXA scan.
Timepoint [1] 352287 0
0, 3 and 9 months post-enrolment
Secondary outcome [2] 352288 0
Resting Energy Expenditure.
Resting energy expenditure (REE) will be obtained using indirect calorimetry.
Timepoint [2] 352288 0
0, 3 and 9 months post-enrolment
Secondary outcome [3] 352289 0
Gut health.
Microbiome analysis from stool samples.
Timepoint [3] 352289 0
0, 3 and 9 months post-enrolment
Secondary outcome [4] 352291 0
Total cholesterol will be measured in plasma, assayed using Vertical Auto Profile (VAP II) and proton magnetic resonance spectroscopy (NMR LipoProfile III).
Timepoint [4] 352291 0
0, 3 and 9 months post-enrolment
Secondary outcome [5] 352292 0
Sleep Patterns
Wrist worn activity monitors and sleep diaries.
Timepoint [5] 352292 0
0, 3 and 9 months post-enrolment
Secondary outcome [6] 353450 0
Diet quality
4-day food diary analysis
Timepoint [6] 353450 0
0, 3 and 9 months post-enrolment
Secondary outcome [7] 353451 0
Quality of life
SF-36 questionnaire total score
Timepoint [7] 353451 0
0, 3 and 9 months post-enrolment
Secondary outcome [8] 353595 0
Total Energy Expenditure.
Total daily energy expenditure during free-living conditions over 14 days will be quantified using the criterion doubly labelled water (DLW) technique in a subsample of participants (n=24)
Timepoint [8] 353595 0
0, 3 and 9 months post-enrolment
Secondary outcome [9] 353597 0
Blood glucose
Fasting blood glucose and continuous glucose monitoring
Timepoint [9] 353597 0
0. 3 and 9 month post-enrolment
Secondary outcome [10] 353598 0
Inflammation
Analysis of plasma levels of high-sensitivity C-reactive protein (hs-CRP).
Timepoint [10] 353598 0
0, 3 and 9 month post-enrolment
Secondary outcome [11] 353599 0
Personality
Eysenck Personality questionnaire-revised (EPQ-R)
Timepoint [11] 353599 0
0, 3 and 9-month post-enrolment
Secondary outcome [12] 353603 0
Measures of pain
SF36 bodily pain subscale
Timepoint [12] 353603 0
0, 3 and 9 month post-enrolment
Secondary outcome [13] 353605 0
Functional mobility
Timed Up and Go test
Timepoint [13] 353605 0
0, 3 and 9 month post-enrolment
Secondary outcome [14] 353862 0
Mood as assessed by Profile of Mood States
Timepoint [14] 353862 0
0, 3 and 9-month post-enrolment
Secondary outcome [15] 353863 0
Stress as assessed by Perceived Stress Scale
Timepoint [15] 353863 0
0, 3 and 9-months post-enrolment
Secondary outcome [16] 353864 0
Mood as assessed by Zung Self-rating scale for depression
Timepoint [16] 353864 0
0, 3 and 9-month post-enrolment
Secondary outcome [17] 353865 0
Truncal fat will be determined from a whole body DXA scan.
Timepoint [17] 353865 0
0, 3 and 9 month post-enrolment
Secondary outcome [18] 353866 0
Visceral adipose tissue will be estimated using a validated prediction model using a whole body DXA scan.
Timepoint [18] 353866 0
0, 3 and 9 months post-enrolment
Secondary outcome [19] 353867 0
High-density lipoprotein will be measured in plasma assayed using Vertical Auto Profile (VAP II) and proton magnetic resonance spectroscopy (NMR LipoProfile III).
Timepoint [19] 353867 0
0, 3 and 9-month post-enrolment
Secondary outcome [20] 353868 0
Triglycerides will be measured in plasma, assayed using Vertical Auto Profile (VAP II) and proton magnetic resonance spectroscopy (NMR LipoProfile III).
Timepoint [20] 353868 0
0, 3 and 9-month post-enrolment
Secondary outcome [21] 353869 0
Analysis of plasma levels of adiponectin using ELISA assay.
Timepoint [21] 353869 0
0, 3 and 9-month post-enrolment
Secondary outcome [22] 353870 0
Analysis of plasma leptin levels using ELISA assay.
Timepoint [22] 353870 0
0, 3 and 9-month post-enrolment
Secondary outcome [23] 353951 0
Concentration of circulating appetite hormone, Glucagon-like peptide-1 (GLP1) after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [23] 353951 0
0, 3 and 9 months post-enrolment
Secondary outcome [24] 353952 0
Concentration of circulating appetite hormone, ghrelin, after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [24] 353952 0
0, 3 and 9 months post-enrolment
Secondary outcome [25] 353953 0
Concentration of circulating appetite hormone, pancreatic polypeptide (PP), after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [25] 353953 0
0, 3 and 9 months post-enrolment
Secondary outcome [26] 353954 0
Concentration of circulating appetite hormone, Gastric inhibitory polypeptide (GIP), after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [26] 353954 0
0, 3 and 9 months post-enrolment
Secondary outcome [27] 353955 0
Concentration of circulating appetite hormone, peptide YY (PYY), after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [27] 353955 0
0, 3 and 9-months post-enrolment
Secondary outcome [28] 353956 0
Concentration of circulating appetite hormone, C-peptide, after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [28] 353956 0
0, 3 and 9 months post-enrolment
Secondary outcome [29] 353957 0
Concentration of circulating appetite hormone, glucagon, after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [29] 353957 0
0, 3 and 9 months post-enrolment
Secondary outcome [30] 353958 0
Concentration of circulating appetite hormone, Cholecystokinin (CCK), after the consumption of test snack of either almonds or baked fruit-filled cereal bar (control). Analysis using Multiplex assay.
Timepoint [30] 353958 0
0, 3 and 9 months post-enrolment

Eligibility
Key inclusion criteria
• Males and females aged 25-65 years.
• Overweight or obese with BMI between 27.5 -34.9 kg/m2.
• Non-smoker (minimum 6 months).
• Weight stable (within 5kg) in the past 3 months.
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have cardiovascular disease (including uncontrolled high blood pressure) or a chronic disease, including Type-1 or -2 diabetes, thyroid disorders, kidney or liver disease, gastrointestinal disorders requiring medical nutrition therapy (e.g. Crohn’s disease, irritable bowel, coeliac disease)
• Have allergies to nuts, gluten or other components of the test foods.
• Consume more than 30g nuts per week in the month prior to beginning the trial.
• Participant has a recent history (within 12 months) or strong potential for alcohol abuse. Defined as >14 standard drinks per week.
• Are unable to chew hard foods such as nuts.
• Have changed medication or supplementation in the last 3 months.
• Take vitamin, mineral, herbal supplementation or medications that may have an impact on study outcomes.
• Unwilling to stop dietary supplements that influence weight.
• Suffer claustrophobia or a fear of enclosed spaces
• Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study.
• Are pregnant or breastfeeding.
• Show unwillingness to be randomized to either experimental group.
• Failure to satisfy the investigator regarding suitability to participate for any other reason.
• Are unwilling or unable to provide written consent.

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 by project member not involved with participant visits
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assign groups based on sex, BMI and age in the process of randomization by minimization
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
Characteristics between the AED and NFD groups at baseline will be compared using one-way ANOVA, Kruskal–Wallis tests or chi-squared tests (gender). The effects of diet treatment on the dependent measures over time will be analyzed using random effects mixed models, with treatment (AED or NFD) and time (end of weight loss, and end of weight maintenance) being the between and within factors respectively in the analysis. Both intention-to-treat (ITT) and per-protocol analyses (for those who achieve a minimum of 80% compliance with test food consumption) will be completed. Where main effects are identified, Bonferroni post hoc tests will be performed to identify significant differences between means (P set at <0·05).

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

Funding & Sponsors
Funding source category [1] 300761 0
Commercial sector/Industry
Name [1] 300761 0
Almond Board of California
Address [1] 300761 0
1150 Ninth St Suite 1500 Modesto, CA, 95354
Country [1] 300761 0
United States of America
Primary sponsor type
Individual
Name
Assoc.Prof. Alison Coates
Address
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
University of South Australia, City East Campus, North Terrace, GPO Box 2471
Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 300299 0
Individual
Name [1] 300299 0
Prof. Jonathan Buckley
Address [1] 300299 0
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
University of South Australia, City East Campus, North Terrace, GPO Box 2471
Adelaide, South Australia, 5001
Country [1] 300299 0
Australia
Secondary sponsor category [2] 300311 0
Individual
Name [2] 300311 0
Dr. Alison Hill
Address [2] 300311 0
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
University of South Australia, City East Campus, North Terrace, GPO Box 2471
Adelaide, South Australia, 5001
Country [2] 300311 0
Australia
Secondary sponsor category [3] 300312 0
Individual
Name [3] 300312 0
Dr Sze Yen Tan
Address [3] 300312 0
Institute for Physical Activity and Health (IPAN)
Deakin University, 221 Burwood Highway
Burwood, Victoria, 3125
Country [3] 300312 0
Australia
Secondary sponsor category [4] 300313 0
Individual
Name [4] 300313 0
Assoc. Prof. Geraint Rogers
Address [4] 300313 0
Microbiome Research, South Australian Health and Medical Research Institute
North Terrace, Adelaide, SA 5001
Country [4] 300313 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301541 0
University of South Australia HREC
Ethics committee address [1] 301541 0
University of South Australia
GPO Box 2471,
Adelaide,
South Australia, 5001
Ethics committee country [1] 301541 0
Australia
Date submitted for ethics approval [1] 301541 0
15/08/2018
Approval date [1] 301541 0
22/10/2018
Ethics approval number [1] 301541 0
201436

Summary
Brief summary
The primary aim of this project is to investigate whether the inclusion of different types of snack foods in an energy restricted diet (i.e. a diet that provides fewer kilojoules than you currently consume) improves weight loss and limits weight regain. We are also interested in seeing whether there are improvements in cardiovascular, liver and gut health and quality of life and functional mobility. We hypothesize that consuming almonds as a snack, when compared to carbohydrate-rich foods, will lead to greater weight loss during the energy restriction phase and will be more effective at limiting weight gain during the weight maintenance phase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87330 0
A/Prof Alison Coates
Address 87330 0
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
University of South Australia, City East Campus, North Terrace, GPO Box 2471
Adelaide, South Australia, 5001
Country 87330 0
Australia
Phone 87330 0
+61 8 83022313
Fax 87330 0
Email 87330 0
alison.coates@unisa.edu.au
Contact person for public queries
Name 87331 0
A/Prof Alison Coates
Address 87331 0
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
University of South Australia, City East Campus, North Terrace, GPO Box 2471
Adelaide, South Australia, 5001
Country 87331 0
Australia
Phone 87331 0
+61 8 83022313
Fax 87331 0
Email 87331 0
alison.coates@unisa.edu.au
Contact person for scientific queries
Name 87332 0
A/Prof Alison Coates
Address 87332 0
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
University of South Australia, City East Campus, North Terrace, GPO Box 2471
Adelaide, South Australia, 5001
Country 87332 0
Australia
Phone 87332 0
+61 8 83022313
Fax 87332 0
Email 87332 0
alison.coates@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable