Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000437965
Ethics application status
Approved
Date submitted
16/03/2020
Date registered
2/04/2020
Date last updated
2/04/2020
Date data sharing statement initially provided
2/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effect of food anthocyanins on cardiovascular disease biomarkers following a high fat meal challenge in overweight older adults
Scientific title
Acute effect of food anthocyanins following a high fat meal challenge on cardiovascular disease biomarkers in overweight older adults: a cross-over, randomized, double-blind clinical trial.
Secondary ID [1] 300803 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial dysfunction 316676 0
Cardiovascular disease biomarkers 316677 0
Condition category
Condition code
Cardiovascular 314918 314918 0 0
Other cardiovascular diseases
Diet and Nutrition 314919 314919 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 314920 314920 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On test days, participants attended fasted and had a high-fat meal together with either 250 ml of queen garnet plum juice (intervention) or apricot juice (control). The order of juice consumption was conducted by a researcher independent to the data collection using a computer generated randomization sequence. Blinding strategies included colouring of control juice, as well as advertising and consenting participants to a “stone fruit juice study” without providing information on which fruit was being investigated.

The test meals consisted of 1 hash brown (62g) 2 beef chipolatas (90g), 1 croissant (168) served with unsalted butter (5g) and apricot jam (10g) and 2 scrambled eggs (2 x52g eggs, 30mL pure cream, 10g unsalted butter, 0.5g salt). Participant were requested to have the meal in 20 minutes.

A serve of the queen garnet plum juice (intervention) was weighed as 200g of plum puree with 50mL of water added.

Participants were contacted 6 pm on the previous day to ensure compliance with the fasting. It was request that their last meal would be at 8 pm (12 hours of fasting until the test breakfast). Participants could only drink water during that period.
There was a wash-out period of 14 days between tests.
Intervention code [1] 317125 0
Treatment: Other
Comparator / control treatment
An apricot puree (250ml, 99% fruit and 1% water) was chosen as the control juice, due to it having a similar consistency, nutrient and flavonoids content to the queen garnet plum juice, as well as being a lack of anthocyanins.
Control group
Placebo

Outcomes
Primary outcome [1] 323230 0
Endothelial function was measured using Flow-mediated dilatation. The same, blinded researcher administered the test for each participant at two timepoints and was responsible for the analysis of the resulting images in order to prevent inter-rater error. FMD of the brachial artery was measured using a Terason u300 system in combination with a semi-automated computerized analysis system (Brachial Analyzer; Medical Imaging Applications-llc). The brachial artery was imaged longitudinally at 2-10cm proximal to the antecubital fossa. Baseline images were recorded for 60 seconds, after which time a blood pressure cuff was placed around the forearm and inflated to 220mmHg. Blood flow was restricted for 5 minutes, then the cuff was rapidly released, which results in reactive hyperaemia. Images were collected for the 5 minute period following the cuff release. The FMD response was calculated as the relative diastolic diameter change from baseline compared to the peak diastolic diameter, and expressed as a percentage.
Timepoint [1] 323230 0
Before and 2 hours after the high fat meal challenge
Primary outcome [2] 323231 0
Modulation of inflammatory biomarkers. Plasma and serum samples were stored at -80oC, prior to analysis. High sensitivity C-reactive protein (hs CRP) was analysed on a BK400 automated chemistry analyser. Interleukin-1ß (IL-1ß), interleukin-6 (IL-6), tumour necrosing factor-a (TNF-a) were analysed using a Milliplex high sensitivity T cell panel (Merck).
Timepoint [2] 323231 0
Before, 2 hours and 4 hours after the high fat meal challenge
Primary outcome [3] 323232 0
Modulation of lipid profile. Serum samples were assayed using an enzymatic colorimetric assay and total cholesterol and triacylglycerides were analysed on a BK400 automated chemistry analyser.
Timepoint [3] 323232 0
Before, 2 hours and 4 hours after the high fat meal challenge
Secondary outcome [1] 381241 0
Change in blood pressure. Blood pressure was measured using an automated Welch Allyn ABPM 7100. Participants were seated, feet on the floor in a quiet room with a correctly fitting arm cuff . BP was measured on both arms, and a repeat measure taken on the arm with the higher reading, the average of the three readings was recorded.
Timepoint [1] 381241 0
Before, 2 hours and 4 hours after the high fat meal challenge

Eligibility
Key inclusion criteria
. Inclusion criteria: Older adults, male/female, aged over 55 years with the body mass index (BMI) over 25kg/m2.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: current treatment or diagnosis of hypertension or diabetes; chronic liver or renal diseases; history of cardiovascular events; currently taking anti-inflammatory medication, aspirin or warfarin; smoking; diagnosis or self-reported gastrointestinal disorders; allergy to stone fruits or food colorants; impediment in having a full breakfast (English style) early in the morning (not suitable for vegetarians).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study was an acute crossover randomized, controlled, double-blind with a 14 days wash-out period between both arms. On test days, participants attended fasted and had a high-fat meal with either 250 ml of queen garnet plum juice (intervention) or apricot juice (control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of juice consumption was conducted by a researcher independent to the data collection using a computer generated randomization sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Blinding strategies included colouring of control juice, as well as advertising and consenting participants to a “stone fruit juice study” without providing information on which fruit was being investigated.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS (version 25 SPSS Statistic Subscription, IBM, Chicago, IL, USA 2019) was used for all statistical analyses. Descriptive statistics were run to determine mean and standard deviation for all FMD, BP, blood results and participant demographic information. FMD, BP and all blood parameters were analysed using repeated measures ANOVA, with time points and treatment as factors. Visit order was included as a covariate as part of the cross over design. Results with a p value <0.05 were considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/06/2019
Date of last participant enrolment
Anticipated
Actual
15/08/2019
Date of last data collection
Anticipated
Actual
24/10/2019
Sample size
Target
15
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29646 0
2500 - Keiraville
Recruitment postcode(s) [2] 29647 0
2500 - North Wollongong
Recruitment postcode(s) [3] 29648 0
2500 - Wollongong
Recruitment postcode(s) [4] 29649 0
2527 - Albion Park
Recruitment postcode(s) [5] 29650 0
2530 - Horsley
Recruitment postcode(s) [6] 29651 0
2530 - Kanahooka
Recruitment postcode(s) [7] 29652 0
2530 - Dapto
Recruitment postcode(s) [8] 29653 0
2530 - Koonawarra
Recruitment postcode(s) [9] 29654 0
2518 - Corrimal
Recruitment postcode(s) [10] 29655 0
2518 - Towradgi

Funding & Sponsors
Funding source category [1] 305259 0
University
Name [1] 305259 0
University of Wollongong - School of Medicine and Health (SMAH) Collaborative Health and medical small grant
Country [1] 305259 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 305621 0
None
Name [1] 305621 0
Address [1] 305621 0
Country [1] 305621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305601 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 305601 0
Ethics committee country [1] 305601 0
Australia
Date submitted for ethics approval [1] 305601 0
08/02/2019
Approval date [1] 305601 0
29/04/2019
Ethics approval number [1] 305601 0
2019/043

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

Contacts
Principal investigator
Name 100926 0
Prof Karen Charlton
Address 100926 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522
Country 100926 0
Australia
Phone 100926 0
+61 2 42214754
Fax 100926 0
Email 100926 0
[email protected]
Contact person for public queries
Name 100927 0
Karen Charlton
Address 100927 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522
Country 100927 0
Australia
Phone 100927 0
+61 2 42214754
Fax 100927 0
Email 100927 0
[email protected]
Contact person for scientific queries
Name 100928 0
Karen Charlton
Address 100928 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522
Country 100928 0
Australia
Phone 100928 0
+61 2 42214754
Fax 100928 0
Email 100928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All raw line-by-line individual participant data can be requested to the authors, including demographics and outcomes.
When will data be available (start and end dates)?
After publication of results for 5 years.
Available to whom?
Scientific community
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Under request, a link or files can be provided by sending email to [email protected] or other correspondent authors in future publications.


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.