Trial Review

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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
1/05/2023
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
Body Composition as measured by total body scan by DXA which includes total and truncal fat mass (% kg), total and truncal fat free mass (% kg) and visceral adipose tissue (g) measurements.
Timepoint [1] 352287 0
0, 3 and 9 months post-enrolment
Secondary outcome [2] 352288 0
Energy expenditure as measured by activity monitor accelerometry (GeneActiv watch worn for 14 days), resting energy expenditure (REE) as measured by indirect calorimetry (kJ/day), and Total Daily Energy Expenditure (kJ/day) will be quantified using the criterion doubly labelled water (DLW) technique in a subsample of participants (n=24).
Timepoint [2] 352288 0
0, 3 and 9 months post-enrolment
Secondary outcome [3] 352289 0
Faecal microbiome composition. Stool sample DNA analysis (biodiversity and ratios) using 16S rRNA amplicon sequencing
Timepoint [3] 352289 0
0, 3 and 9 months post-enrolment
Secondary outcome [4] 352291 0
Cardiometabolic Health will be monitored by examining many parameters. The measurements include continuous glucose monitoring (14 days) using Flash Glucose sensors (mmol/L); fasting plasma insulin (ELISA, mU/L) and calculation of HOMA (based on fasting glucose and insulin levels); fasting plasma cholesterols (total, HDL-C, LDL-C mmol/L) and fasting plasma triglycerides (mmol/L) using automated clinical chemical analyser; fasting serum oxidised LDL (ELISA, mmol/L), apolipoprotein A1 and apolipoprotein B (mmol/L), and lipoprotein subclasses (particle number and size (nm), using Vertical Auto Profile (VAPII) 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 as monitored by accelerometry (GeneActiv wrist watch worn for 14 days) and self-report sleep diaries (14 days).
Timepoint [5] 352292 0
0, 3 and 9 months post-enrolment
Secondary outcome [6] 353450 0
Energy Intake and diet quality will be measured by 4-day Food diary (self-report) and 24-hr food recalls as reported to a dietitian, both will be analysed using FoodWorks (nutrition analysis software).
Timepoint [6] 353450 0
Food diaries will be analysed at 0, 3 and 9 month post-enrolment and 24 hour recalls will be performed at numerous times during the 9-month intervention.
Secondary outcome [7] 353451 0
Quality of Life will be assessed by SF-36 questionnaire for total score and bodily pain.
Timepoint [7] 353451 0
0, 3 and 9 months post-enrolment
Secondary outcome [8] 353598 0
Inflammation will be measured by analysing F2-isoprostane, C-reactive protein and adiponectin levels in fasting plasma and F2-isoprostane levels in urine
Timepoint [8] 353598 0
0, 3 and 9 month post-enrolment
Secondary outcome [9] 353605 0
Functional mobility
Timed Up and Go test
Timepoint [9] 353605 0
0, 3 and 9 month post-enrolment
Secondary outcome [10] 353862 0
Mood as assessed by Profile of Mood States
Timepoint [10] 353862 0
0, 3 and 9-month post-enrolment
Secondary outcome [11] 353863 0
Stress as assessed by Perceived Stress Scale
Timepoint [11] 353863 0
0, 3 and 9-months post-enrolment
Secondary outcome [12] 353864 0
Depression as assessed by Zung Depression Self-Rating Scale
Timepoint [12] 353864 0
0, 3 and 9-month post-enrolment
Secondary outcome [13] 353870 0
Fasting and Postprandial gut hormones and glucose response. Plasma Glucagon-like peptide-1 (GLP-1), ghrelin, leptin, Pancreatic Polypeptide (PP), Glucose-dependent insulinotropic Polypeptide (GIP), Peptide Tyrosine Tyrosine (Peptide YY), Cholecystokinin (CCK), C-peptide, Glucagon and Glucose will be measured before and after (5 sampling time points) the consumption of a test snack of either almonds or fruit-filled cereal bar (control). Analysis is either by Multiplex assay or ELISA. in the case of gut hormones or automated clinical analyser for glucose.
Timepoint [13] 353870 0
0, 3 and 9-month post-enrolment
Secondary outcome [14] 393076 0
Change in blood pressure reading, as assessed by digital blood pressure monitor
Timepoint [14] 393076 0
0, 3 months and 9-months post enrolment
Secondary outcome [15] 393077 0
Study Food Liking and Palatability using questionnaires -Labelled Affect Magnitude Scale and Food Action Rating Scale
Timepoint [15] 393077 0
0 and 9 months post-enrolment
Secondary outcome [16] 393078 0
Body mass index (BMI). Weight will be measured using digital scales in kg (to the nearest 1 decimal point), height measured using stadiometer in metres (to the nearest 1 decimal point).
Timepoint [16] 393078 0
0, 3 and 9 months post-enrolment
Secondary outcome [17] 393079 0
Waist circumference (cm) at the midpoint between the lower costal (10th rib) border and the iliac crest using a measuring tape according to the protocol of the International Society for Anthropometry and Kinanthropometry,
Timepoint [17] 393079 0
0, 3 and 9 months post-enrolment
Secondary outcome [18] 393080 0
Subjective Drive to Eat as measured by visual analogue scales (mm) during 2.5 hour period after eating test snack food
Timepoint [18] 393080 0
0, 3 and 9 months post-enrolment
Secondary outcome [19] 393081 0
Psychological Influence on food environment as assessed by Power of Food Survey
Timepoint [19] 393081 0
0, 3 and 9 months post-enrolment
Secondary outcome [20] 393082 0
Physical Activity as assessed by International Physical Activity Questionnaire (self-report)
Timepoint [20] 393082 0
0, 3 and 9 months post-enrolment
Secondary outcome [21] 393083 0
Energy Consumed at buffet meal. Calculated from recorded food choices and quantities eaten at buffet
Timepoint [21] 393083 0
0, 3 and 9 months post-enrolment
Secondary outcome [22] 393084 0
Food Craving as assessed by questionnaire (Food Craving Scale)
Timepoint [22] 393084 0
0, 3 and 9 months post-enrolment
Secondary outcome [23] 393085 0
Eating Attitudes questionnaire EAT-26
Timepoint [23] 393085 0
0, 3 and 9 months post-enrolment
Secondary outcome [24] 393086 0
Food choice as assessed by Finickiness questionnaire
Timepoint [24] 393086 0
0, 3 and 9 months post-enrolment
Secondary outcome [25] 393087 0
Food Control as assessed by Control of Eating questionnaire
Timepoint [25] 393087 0
0, 3 and 9 months post-enrolment
Secondary outcome [26] 393088 0
Pain as assessed by McGill Pain scale (VAS) and Chronic Pain Scale (VAS)
Timepoint [26] 393088 0
0, 3 and 9 months post-enrolment
Secondary outcome [27] 393089 0
Personality Measure as assessed by Brief Sensation Seeking Scale
Timepoint [27] 393089 0
0 months post-enrolement
Secondary outcome [28] 393090 0
Liver health as assessed by liver ultrasound and serum plasma enzyme analysis, Serum Alanine Aminotransferase (ALT), Serum Aspartate Aminotransferase (AST), Serum Alkaline Phosphatase (ALP) and Serum gamma -Glutamyltransferase (GGT). Fatty liver index will be calculated using these measures and reported as an outcome.
Timepoint [28] 393090 0
0, 3 and 9 months post-enrolment
Secondary outcome [29] 393091 0
Sleep quality as assessed by Pittsburgh Sleep Quality Index questionnaire
Timepoint [29] 393091 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
Sex
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
Completed
Date of first participant enrolment
Anticipated
28/01/2019
Actual
4/02/2019
Date of last participant enrolment
Anticipated
1/06/2021
Actual
3/06/2021
Date of last data collection
Anticipated
1/01/2022
Actual
25/11/2021
Sample size
Target
134
Accrual to date
Final
137
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
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
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
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
[email protected]
Contact person for public queries
Name 87331 0
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
[email protected]
Contact person for scientific queries
Name 87332 0
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
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcute feeding with almonds compared to a carbohydrate-based snack improves appetite-regulating hormones with no effect on self-reported appetite sensations: a randomised controlled trial.2023https://dx.doi.org/10.1007/s00394-022-03027-2
EmbaseAlmonds vs. carbohydrate snacks in an energy-restricted diet: Weight and cardiometabolic outcomes from a randomized trial.2023https://dx.doi.org/10.1002/oby.23860
N.B. These documents automatically identified may not have been verified by the study sponsor.