Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001270606
Ethics application status
Approved
Date submitted
29/10/2014
Date registered
4/12/2014
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Date results information initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of purple Plum juice on blood pressure in overweight/obese
participants.
Scientific title
The effect of Prunus salicina (Queen Garnet) Plum juice on blood pressure in mild hypertensive overweight/obese subjects.
Secondary ID [1] 285538 0
None
Universal Trial Number (UTN)
U1111-1163-2939
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild hypertension in overweight/obese subjects. 293355 0
Condition category
Condition code
Diet and Nutrition 293630 293630 0 0
Obesity
Cardiovascular 293774 293774 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Queen garnet plum juice is made from a fresh plums by Department of Agriculture, Fisheries and Forestry, Queensland, Australia.
All participants will be requested to drink 200 ml/day juice every morning for a duration of 12 weeks.
All participants will be given a juice calendar and were requested to fill in juice calender, every day after drinking juice. Participants were also requested to return the empty juice bottles during their visit to Nutrition clinic every fortnight.
Intervention code [1] 290480 0
Treatment: Other
Comparator / control treatment
commercially available Raspberry cordial from concentrate, Bickford’s Australia, Salisbury South, SA, Australia, is diluted and packed by Department of Agriculture, Fisheries and Forestry, Queensland, Australia.
All participants will be requested to drink 200 ml/day juice every morning for a duration of 12 weeks.
All participants will be given a juice calendar and were requested to fill in juice calender, every day after drinking juice. Participants were also requested to return the empty juice bottles during their visit to Nutrition clinic every fortnight.
Control group
Placebo

Outcomes
Primary outcome [1] 293441 0
The primary object for this study is to monitor blood pressure. Blood pressure is measured by using an automatic sphygmomanometer.
Timepoint [1] 293441 0
At 12 weeks after initiation of the trial.
Secondary outcome [1] 311063 0
Changes in plasma lipids
Timepoint [1] 311063 0
At 12 weeks after initiation of the trial.

Eligibility
Key inclusion criteria
Participants will need to be overweight with a BMI of greater than 25 or a waist circumference >94cm (male), >80cm (female), systolic blood pressure 130-159 mmHg and diastolic blood pressure 85-99 mmHg.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Liver, kidney and heart disease, pregnancy, type 1 diabetes, type 2 diabetes with any medication, cigarette smoking and the use of any medication for weight loss or hypertension.

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)
Selected participants after initial screening with blood pressure will be randomized into two separate groups , using a computer programe for randomization (one group goes with plums juice and other group goes with placebo plum juice). The placebo and plum juice will be packed in unlabeled opaque bottles to maintain double blinding and this juice will be given to participants on their visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once the potential participants were recruited after initial screening, the patient data will be entered in to computer for creating a randomization of participants in to 2 groups.
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
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Male and Female participants (n=70) between the ages of 18-65 who are overweight with a BMI of greater than 25 or a waist circumference >94cm (male), >80cm (female), systolic blood pressure 130-159 mmHg and diastolic blood pressure 85-99 mmHg will be recruited for this study. The sample size was determined by statistical power analysis (two tailed t-test at the 5% significance level for the power of 90%) of expected differences in the major measured variable of experiment i.e. systolic blood pressure (Brocel et al 2010). Twenty five participants in each group are required for significant differences in outcome measures. However due to the high dropout rate in human trials the maximum number of participants to be recruited is 35 in each group

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
16/06/2015
Date of last participant enrolment
Anticipated
28/08/2015
Actual
31/08/2015
Date of last data collection
Anticipated
Actual
30/10/2018
Sample size
Target
70
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8841 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 290145 0
University
Name [1] 290145 0
Victoria University
Country [1] 290145 0
Australia
Primary sponsor type
Individual
Name
A/Prof Michael Mathai
Address
College of Health & Biomedicine
Victoria University,
PO Box 14428
Australia Melbourne,
Victoria 8001
Country
Australia
Secondary sponsor category [1] 288854 0
Individual
Name [1] 288854 0
Maharshi Bhaswant
Address [1] 288854 0
College of Health & Biomedicine
Victoria University,
PO Box 14428
Australia Melbourne,
Victoria 8001
Country [1] 288854 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291853 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 291853 0
PO Box 14428
Australia Melbourne,
Victoria 8001
Ethics committee country [1] 291853 0
Australia
Date submitted for ethics approval [1] 291853 0
28/10/2014
Approval date [1] 291853 0
15/04/2015
Ethics approval number [1] 291853 0
HRE14­281

Summary
Brief summary
Metabolic syndrome is characterised by a cluster of cardiovascular risk factors, including central obesity, elevated blood pressure, dyslipidemia (low HDL cholesterol, high triglyceride levels & LDL cholesterol) and elevated plasma glucose levels. Individuals with metabolic syndrome have central obesity and at least one other risk factor to be clinical diagnosed with the syndrome. Metabolic syndrome is an emerging clinical challenge and imperative public health issue.
Subjects with metabolic syndrome have a markedly increased risk of cardiovascular mortality.
Prunus salicina, Queen Garnet plum (QGP), is a fruit that was naturally bred to have a high anthocyanin and antioxidant content, in a Queensland Government agriculture initiative. Queen Garnet plums showed anti-obesigenic properties. Studies in laboratory animals have shown that treatment with Queen Garnet plum juice improved the unhealthy blood lipid profile caused by a high-carbohydrate, high-fat diet.
The primary object for this study is to monitor blood pressure changes with Queen Garnet plum juice. Blood pressure is measured by using an automatic sphygmomanometer for 12 weeks of duration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52266 0
A/Prof Michael Mathai
Address 52266 0
College of Health & Biomedicine
Victoria University,
PO Box 14428
Australia Melbourne,
Victoria 8001
Country 52266 0
Australia
Phone 52266 0
+61 399192211
Fax 52266 0
Email 52266 0
Michael.Mathai@vu.edu.au
Contact person for public queries
Name 52267 0
A/Prof Michael Mathai
Address 52267 0
College of Health & Biomedicine
Victoria University,
PO Box 14428
Australia Melbourne,
Victoria 8001
Country 52267 0
Australia
Phone 52267 0
+61 399192211
Fax 52267 0
Email 52267 0
Michael.Mathai@vu.edu.au
Contact person for scientific queries
Name 52268 0
A/Prof Michael Mathai
Address 52268 0
College of Health & Biomedicine
Victoria University,
PO Box 14428
Australia Melbourne,
Victoria 8001
Country 52268 0
Australia
Phone 52268 0
+61 399192211
Fax 52268 0
Email 52268 0
Michael.Mathai@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
need to decide


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.