Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001004550
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
19/08/2024
Date last updated
19/08/2024
Date data sharing statement initially provided
19/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of daily apple consumption on metabolic biochemistry in high-risk adults: a randomised control trial.
Scientific title
Effects of daily apple consumption on metabolic biochemistry in high-risk adults: a randomised control trial.
Secondary ID [1] 312620 0
None
Universal Trial Number (UTN)
Trial acronym
APPLE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 334559 0
type 2 diabetes 334560 0
Condition category
Condition code
Cardiovascular 331163 331163 0 0
Hypertension
Metabolic and Endocrine 331164 331164 0 0
Diabetes
Diet and Nutrition 331165 331165 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial assesses the impact of consuming two high-polyphenol apples on cardiometabolic disease risk factors and microbiome function. It will take place at the Harry Perkins Medical Institute (South). This randomized, crossover dietary intervention study utilizes high-risk individuals. Each participant will consume either two high-polyphenol apples or two low-polyphenol pears (as a control) daily for 8 weeks, with a minimum 4-week washout period in between. Volunteers are to adhere to their usual diet but are required to abstain from probiotics/prebiotics and any additional apples or pears intake, including whole fruits, juices, or dried fruits.

Habitual diet will be monitored using Intake24, an online validated tool for recording food intake. This self-reported monitoring will occur prior to the start of the study (baseline), and at week 4 and 8 at each intervention period. In addition, volunteers are asked to provide evidence of daily food waste using a time stamped photo.
Intervention code [1] 329135 0
Prevention
Comparator / control treatment
Consuming two low polyphenol pears daily for 8 weeks
Control group
Active

Outcomes
Primary outcome [1] 338930 0
To determine the changes in total cholesterol (TC) following the consumption of two apples or pears on individual with high cardiometabolic disease risk
Timepoint [1] 338930 0
Before intervention and at the end of each intervention (at week 8)
Primary outcome [2] 339086 0
To determine the changes in low density lipoprotein cholesterol LDL) following the consumption of two apples or pears on individual with high cardiometabolic disease risk
Timepoint [2] 339086 0
Before intervention and at the end of each intervention (at week 8)
Secondary outcome [1] 437936 0
To investigate changes in inflammatory markers, supramolecular phospholipid composite peaks (SPC1, 2, and 3), following the consumption of apples or pears by individuals at high risk of cardiometabolic disease.
Timepoint [1] 437936 0
Before intervention and at the end of each intervention (at week 8)
Secondary outcome [2] 437937 0
To investigate changes in small molecule metabolites following the consumption of apples or pears by individuals at high risk of cardiometabolic disease. This is an exploratory outcome
Timepoint [2] 437937 0
Before intervention and at the end of each intervention (at week 8)
Secondary outcome [3] 437938 0
To investigate the changes in faecal microbiome composition following the consumption of apples/pears in individuals with high cardiometabolic disease risk.
Timepoint [3] 437938 0
Before intervention and at the end of each intervention (at week 8)
Secondary outcome [4] 438501 0
To investigate changes in glycoproteins (GlycA and B), following the consumption of apples or pears by individuals at high risk of cardiometabolic disease.
Timepoint [4] 438501 0
Before intervention and at the end of each intervention (at week 8).

Eligibility
Key inclusion criteria
• Adult between 18 – 70 years.
• Body mass index is between 20 -30 kg/m2.
• High-risk of cardiometabolic disease group based on an AUSDRISK score of 9 or higher, with at least one risk factor other than age or gender
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Medical history of heart disease and diabetes mellitus, kidney, liver diseases, pancreatic diseases or gastrointestinal disorders.
• Currently taking medication for hyperlipidaemia, hypertension, gastrointestinal motility issues, inflammation or immunosuppressants.
• Pregnancy (current or planned), or lactation.
• History of alcohol misuse.
• Antibiotics intake <2 months ago.
• Food/vitamin supplement use (e.g. fish oil) unless willing to stop for 1 month before study commencement.
• Habitual intake of at least 1 apple or pear/day.
• On a special diet e.g. vegetarian and vegan diet or planned weight loss regimen.

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)
The investigator recruiting participants will be unable to see which group they will be allocated to until after recruitment when the randomisation will be completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table created using computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317051 0
Other
Name [1] 317051 0
Future Food Systems
Country [1] 317051 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Country
Australia
Secondary sponsor category [1] 319300 0
Government body
Name [1] 319300 0
Department of Primary Industries and Regional Development (DPIRD)
Address [1] 319300 0
Country [1] 319300 0
Australia
Secondary sponsor category [2] 319301 0
Commercial sector/Industry
Name [2] 319301 0
Fruit West Cooperative Ltd
Address [2] 319301 0
Country [2] 319301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315804 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 315804 0
Ethics committee country [1] 315804 0
Australia
Date submitted for ethics approval [1] 315804 0
Approval date [1] 315804 0
11/07/2024
Ethics approval number [1] 315804 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135854 0
A/Prof Ruey Leng Loo
Address 135854 0
Australian National Phenome Centre/Centre for Computational and Systems Medicine, Murdoch University, 5 Robin Warren Drive, Murdoch WA 6150
Country 135854 0
Australia
Phone 135854 0
+61893601371
Fax 135854 0
Email 135854 0
[email protected]
Contact person for public queries
Name 135855 0
Ruey Leng Loo
Address 135855 0
Australian National Phenome Centre/Centre for Computational and Systems Medicine, Murdoch University, 5 Robin Warren Drive, Murdoch WA 6150
Country 135855 0
Australia
Phone 135855 0
+61893601371
Fax 135855 0
Email 135855 0
[email protected]
Contact person for scientific queries
Name 135856 0
Ruey Leng Loo
Address 135856 0
Australian National Phenome Centre/Centre for Computational and Systems Medicine, Murdoch University, 5 Robin Warren Drive, Murdoch WA 6150
Country 135856 0
Australia
Phone 135856 0
+61893601371
Fax 135856 0
Email 135856 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
No additional documents have been identified.