Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000269235
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
21/02/2018
Date last updated
10/05/2019
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effects of apple consumption on vascular health
Scientific title
Short-term effects of apple consumption on endothelial function in volunteers at risk for cardiovascular disease
Secondary ID [1] 294067 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 306623 0
Condition category
Condition code
Cardiovascular 305727 305727 0 0
Coronary heart disease
Cardiovascular 305728 305728 0 0
Hypertension
Diet and Nutrition 305729 305729 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, controlled, cross-over designed trial will be performed. The total duration of the trial will be 16 weeks. Each participant will complete 2 intervention periods of 4 weeks each in random order. These will be separated by a 4 week washout period. In addition, the first 4 week intervention period will be preceded by a 4 week run-in period. The two 4 week intervention periods will correspond to:
1. Active – consumption of 200 g of fresh apple (approximately one large apple) blended with water each day for 4 weeks (total fluid volume 400 ml)
2. Control – consumption 400 ml of water + 25 g maltodextrin each day for 4 weeks.
Participants will attend the School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Unit located in the Medical Research Foundation Building, Level 3, Rear 50 Murray St, Perth.
To monitor adherence, participants will be asked to record intervention intake in a diary that will be provided. Participants will also be asked to return unused maltodextrin powder.
Intervention code [1] 300342 0
Prevention
Comparator / control treatment
Consumption of 400 ml of water + 25 g maltodextrin each day for 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 304806 0
Endothelial function will be measured by using ultrasound by flow-mediated dilation (FMD) of the brachial artery
Timepoint [1] 304806 0
Beginning and end of each 4 week intervention period
Secondary outcome [1] 343233 0
Measurement of the faecal microflora (microbiome) by 16s rRNA sequencing
Timepoint [1] 343233 0
End of each baseline/washout period and during the final week of the two intervention periods
Secondary outcome [2] 343234 0
Blood pressure will be measured at home using an upper arm portable sphygmomanometer
Timepoint [2] 343234 0
Daily for 7 days at the end of each baseline/washout period and during the final week of the two intervention periods
Secondary outcome [3] 343235 0
Arterial stiffness will be measured by pulse wave velocity and augmentation index
Timepoint [3] 343235 0
Beginning and end of each 4 week intervention period
Secondary outcome [4] 343236 0
Circulating biomarkers of nitric oxide metabolism (plasma nitrate, nitrite and s-nitrosothiols) measured using chemiluminescence and GCMS.
Timepoint [4] 343236 0
Beginning and end of each 4 week intervention period
Secondary outcome [5] 343367 0
Faecal short-chain fatty acids measured using GCMS.
Timepoint [5] 343367 0
Beginning and end of each 4-week intervention period
Secondary outcome [6] 343368 0
Plasma short-chain fatty acids measured using GCMS.
Timepoint [6] 343368 0
Beginning and end of each 4-week intervention period

Eligibility
Key inclusion criteria
Men and women will be aged between 18 and 75 years
Volunteers are included in the study if they have at least one of the following: elevated blood pressure (120 mmHg< systolic BP <150 mmHg), moderately elevated blood sugar levels (5.6 mmol/L< glucose <6.5 mmol/L), raised fasting cholesterol (5 mmol/L < total cholesterol <8 mmol/L) or central obesity (measured by waist circumference; men >94 cm; women >80 cm).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Body mass index <18 or >40 kg/m2
• Systolic blood pressure greater than or equal to 150 mmHg
• Diastolic BP greater than or equal to 100 mmHg
• Diagnosed diabetes
• Non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 6.5 mmol/L
• Current or recent (<12 months) smoking
• History of cardiovascular or peripheral vascular disease
• Use of blood pressure lowering or cholesterol lowering medication
• Psychiatric illness or other major illnesses such as cancer
• Alcohol intake >210 g per week for women and >280 g per week for men
• Current or recent (within previous 6 months) significant weight loss or gain (>6% of body weight) or actively trying to lose weight
• Women who were lactating, pregnant or wishing to become pregnant during the study.
• Inability to attend clinic/office visits
• Use of antibiotics (within previous 2 months)
• current or recent (<6 months) smoking
• Inability or unwillingness to follow the study protocol
• Systolic blood pressure less than or equal to 100 mmHg
• Diastolic BP less than or equal to50 mmHg

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 treatment order for eligible individuals will be randomly assigned using computer generated random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers using Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/04/2018
Actual
1/05/2018
Date of last participant enrolment
Anticipated
22/06/2018
Actual
9/07/2018
Date of last data collection
Anticipated
2/11/2018
Actual
26/10/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 298695 0
University
Name [1] 298695 0
Edith Cowan University
Country [1] 298695 0
Australia
Funding source category [2] 298696 0
Commercial sector/Industry
Name [2] 298696 0
Fruit West Co-operative Ltd
Country [2] 298696 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 297865 0
None
Name [1] 297865 0
Address [1] 297865 0
Country [1] 297865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299647 0
ECU Human Research Ethics Committee
Ethics committee address [1] 299647 0
Ethics committee country [1] 299647 0
Australia
Date submitted for ethics approval [1] 299647 0
Approval date [1] 299647 0
26/07/2017
Ethics approval number [1] 299647 0
18090

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

Contacts
Principal investigator
Name 81158 0
Prof Jonathan Hodgson
Address 81158 0
School of Medical & Health Sciences
Edith Cowan University
Royal Perth Hospital Unit
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country 81158 0
Australia
Phone 81158 0
+61 8 9224 0267
Fax 81158 0
Email 81158 0
[email protected]
Contact person for public queries
Name 81159 0
Nicola Bondonno
Address 81159 0
University of Western Australia
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country 81159 0
Australia
Phone 81159 0
+61 8 9224 0342
Fax 81159 0
Email 81159 0
[email protected]
Contact person for scientific queries
Name 81160 0
Catherine Bondonno
Address 81160 0
School of Medical & Health Sciences
Edith Cowan University
Royal Perth Hospital Unit
Medical Research Foundation Building
Level 3, Rear 50 Murray Street
PERTH Western Australia 6000
Country 81160 0
Australia
Phone 81160 0
+61 8 9224 0339
Fax 81160 0
Email 81160 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
We do not have ethics approval for this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2040Informed consent form    374525-(Uploaded-09-05-2019-12-41-29)-Study-related document.docx
2041Ethical approval    374525-(Uploaded-09-05-2019-12-41-29)-Study-related document.pdf



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.