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Trial registered on ANZCTR
Registration number
ACTRN12625000919415
Ethics application status
Approved
Date submitted
23/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigating whether drinking purple and red fruit juices can improve memory, reduce inflammation, and support metabolic health in people with obesity
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Scientific title
The effect of purple and red-rich fruit juice on inflammation, adiponectin, oxidative stress, and brain function in adults with obesity: a pilot randomised controlled trial
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Secondary ID [1]
314966
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
338278
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Condition category
Condition code
Metabolic and Endocrine
334580
334580
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0
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Other metabolic disorders
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Neurological
334581
334581
0
0
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Studies of the normal brain and nervous system
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Inflammatory and Immune System
334582
334582
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0
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Other inflammatory or immune system disorders
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Diet and Nutrition
334702
334702
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Brief name: Red fruit juice and Purple extract Intervention
Arm 1 – Dragon Fruit Juice Group:
Participants will consume 250 mL of red dragon fruit juice daily for 6 weeks. The juice contains approximately 55 mg of betalains per serving and will be provided in individual bottles. Participants are instructed to store the juice in their home refrigerator and consume one bottle per day.
Dose: 250 mL/day
Bioactives: ~55 mg betalains
Duration: 6 weeks
Mode of administration: Oral, self-administered at home
Materials used: Bottled red dragon fruit juice
Delivered by: Research team from the University of Wollongong
Monitoring: Daily juice tracker; bottle return of unused juice at follow-up and paper diary.
Arm 2 – Queen Garnet Plum Extract Group:
Participants will consume 30 mL/day of Queen Garnet plum extract, providing approximately 300 mg of anthocyanins per day. The extract will be provided in individual daily doses and stored in the refrigerator.
Dose: 30 mL/day
Bioactives: ~300 mg anthocyanins
Duration: 6 weeks
Mode of administration: Oral, self-administered at home
Materials used: Bottled extract
Delivered by: Research team from the University of Wollongong
Monitoring: Daily juice tracker; bottle return of unused juice at follow-up and paper diary.
Adherence and Fidelity Monitoring:
Participants will complete a daily intake tracker
Used bottles and extract packaging will be collected at follow-up
Verbal and written instructions provided at baseline clinic visit
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Intervention code [1]
331559
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Treatment: Other
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Intervention code [2]
331560
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Lifestyle
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Comparator / control treatment
Control Group: Raspberry Cordial (Placebo)
Participants in the control group will consume 250 mL of commercially available raspberry-flavored cordial per day for 6 weeks. The cordial is similar in appearance and taste but does not contain meaningful levels of anthocyanins or betalains, serving as a placebo control.
Dose: 250 mL once daily
Duration: 6 weeks
Mode of administration: Oral, self-administered at home
Materials used: Bottled raspberry cordial
Procedures: Participants are instructed to store the cordial in the refrigerator and consume one full bottle daily
Delivery personnel: Research team at the University of Wollongong (initial delivery and instructions)
Monitoring: Daily juice tracker; bottle return of unused juice at follow-up and paper diary.
Fidelity strategy: Matched appearance and taste to intervention juices to maintain blinding
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Control group
Placebo
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Outcomes
Primary outcome [1]
342259
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Change in serum adiponectin levels
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Assessment method [1]
342259
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Fasting venous blood samples will be collected into serum-separating tubes (SST), centrifuged, and plasma aliquots stored at –80°C until analysis. Adiponectin concentrations will be measured using a validated enzyme-linked immunosorbent assay (ELISA)
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Timepoint [1]
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [1]
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Change in serum tumour necrosis factor alpha (TNF-a) levels
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Assessment method [1]
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Fasting venous blood samples will be collected into serum-separating tubes (SST), centrifuged, and plasma stored at –80°C until analysis. TNF-a concentrations will be measured using a validated multiplex immunoassay (Luminex platform).
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Timepoint [1]
450168
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [2]
450169
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Change in fasting serum glucose levels
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Assessment method [2]
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Fasting serum glucose will be measured using an enzymatic colorimetric assay on an automated clinical chemistry analyser.
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Timepoint [2]
450169
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [3]
450171
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Change in fasting serum insulin concentrations
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Assessment method [3]
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Fasting serum insulin will be measured using a validated immunoassay.
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Timepoint [3]
450171
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [4]
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Change in serum leptin levels
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Assessment method [4]
450172
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Assessment method: Fasting serum samples will be analysed using commercially available enzyme-linked immunosorbent assays (ELISA) for leptin.
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Timepoint [4]
450172
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [5]
450173
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Change in liver function biomarker Alanine aminotransferase (ALT)
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Assessment method [5]
450173
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Fasting serum levels of Alanine aminotransferase (ALT) will be measured using standard clinical chemistry methods on an automated analyser.
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Timepoint [5]
450173
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [6]
450174
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Change in lipid profile - Total cholesterol
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Assessment method [6]
450174
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Fasting serum lipid concentrations will be measured using enzymatic colorimetric assays on a clinical chemistry analyser.
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Timepoint [6]
450174
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [7]
450175
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Change in systolic and diastolic blood pressure
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Assessment method [7]
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Blood pressure will be measured using a validated and calibrated automated sphygmomanometer following 5 minutes of rest in the supine position.
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Timepoint [7]
450175
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [8]
450176
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Change in verbal memory performance
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Assessment method [8]
450176
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Assessed using the Rey Auditory Verbal Learning Test (RAVLT), including total learning and delayed recall scores after a 20-minute interval.
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Timepoint [8]
450176
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [9]
450177
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Change in executive function and processing speed
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Assessment method [9]
450177
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Assessed using the Trail Making Test (TMT) – Part A and Part B.
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Timepoint [9]
450177
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [10]
450178
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Change in visuospatial memory
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Assessment method [10]
450178
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Assessment method: Assessed using the delayed recall score (3 minutes) from the Complex Figure Test (CFT).
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Timepoint [10]
450178
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [11]
450179
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Change in mood states -Depression
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Assessment method [11]
450179
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Assessment method: Self-reported using the 21-item Depression Anxiety Stress Scale (DASS-21).
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Timepoint [11]
450179
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [12]
450180
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Change in cutaneous microvascular reactivity
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Assessment method [12]
450180
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Measured using Laser Speckle Contrast Imaging (Pericam PSI, Perimed) with a post-occlusive reactive hyperaemia protocol applied to the forearm.
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Timepoint [12]
450180
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [13]
450181
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Change in gene expression of Adiponectin Receptor 1 (ADIPOR1) in whole blood
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Assessment method [13]
450181
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [13]
450181
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [14]
450545
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Change in serum Interleukin-6 (IL-6) levels
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Assessment method [14]
450545
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Fasting venous blood samples will be collected into serum-separating tubes (SST), centrifuged, and plasma stored at –80°C until analysis. IL-6 concentrations will be measured using a validated multiplex immunoassay (Luminex platform).
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Timepoint [14]
450545
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [15]
450546
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Change in serum Interleukin-10 (IL-10) levels
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Assessment method [15]
450546
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Fasting venous blood samples will be collected into serum-separating tubes (SST), centrifuged, and plasma stored at –80°C until analysis. IL-10 concentrations will be measured using a validated multiplex immunoassay (Luminex platform).
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Timepoint [15]
450546
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [16]
450547
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Change in liver function biomarker Aspartate aminotransferase (AST)
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Assessment method [16]
450547
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Fasting serum levels of Aspartate aminotransferase (AST) will be measured using standard clinical chemistry methods on an automated analyser.
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Timepoint [16]
450547
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [17]
450548
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Change in liver function biomarker Gamma-glutamyl transferase (GGT)
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Assessment method [17]
450548
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Fasting serum levels of Gamma-glutamyl transferase (GGT) will be measured using standard clinical chemistry methods on an automated analyser.
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Timepoint [17]
450548
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [18]
450549
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Change in lipid profile - HDL
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Assessment method [18]
450549
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Fasting serum lipid concentrations will be measured using enzymatic colorimetric assays on a clinical chemistry analyser.
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Timepoint [18]
450549
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [19]
450550
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Change in lipid profile - LDL
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Assessment method [19]
450550
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Fasting serum lipid concentrations will be measured using enzymatic colorimetric assays on a clinical chemistry analyser.
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Timepoint [19]
450550
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [20]
450551
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Change in lipid profile - Triglycerides
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Assessment method [20]
450551
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Fasting serum lipid concentrations will be measured using enzymatic colorimetric assays on a clinical chemistry analyser.
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Timepoint [20]
450551
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [21]
450552
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Change in mood states - Anxiety
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Assessment method [21]
450552
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Assessment method: Self-reported using the 21-item Depression Anxiety Stress Scale (DASS-21).
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Timepoint [21]
450552
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [22]
450553
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Change in mood states - Stress
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Assessment method [22]
450553
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Assessment method: Self-reported using the 21-item Depression Anxiety Stress Scale (DASS-21).
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Timepoint [22]
450553
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [23]
450554
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Change in gene expression of Leptin receptor (LEPR) in whole blood
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Assessment method [23]
450554
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [23]
450554
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [24]
450555
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Change in gene expression of tumour necrosis factor alpha (TNFA) in whole blood
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Assessment method [24]
450555
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [24]
450555
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [25]
450556
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Change in gene expression of Interleukin-6 (IL6) in whole blood
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Assessment method [25]
450556
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [25]
450556
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [26]
450557
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Change in gene expression of Interleukin-10 (IL10) in whole blood
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Assessment method [26]
450557
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [26]
450557
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [27]
450558
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Change in gene expression of Superoxide dismutase (SOD) in whole blood
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Assessment method [27]
450558
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [27]
450558
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Baseline and 6 weeks after commencement of intervention
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Secondary outcome [28]
450559
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Change in gene expression of Catalase (CAT) in whole blood
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Assessment method [28]
450559
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Total RNA will be extracted from whole blood collected into RNA-stabilising tubes. Gene expression will be quantified using real-time quantitative PCR (RT-qPCR).
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Timepoint [28]
450559
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Baseline and 6 weeks after commencement of intervention
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Eligibility
Key inclusion criteria
Participants will be eligible if they:
- Are aged between 45 and 75 years;
- Have a Body Mass Index (BMI) over 30 kg/m² (classified as obesity);
- Are fluent in English (spoken and written);
- Are able and willing to attend two clinical visits and consume the study beverage daily for 6 weeks;
- Provide written informed consent.
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Minimum age
45
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded if they:
- Have a current or past diagnosis of neurodegenerative disease (e.g. Alzheimer’s disease, Parkinson’s disease, multiple sclerosis);
- Have major psychiatric disorders (e.g. schizophrenia, bipolar disorder);
- Have been diagnosed with type 1 or type 2 diabetes mellitus;
- Have clinically significant cardiovascular, renal, hepatic, or gastrointestinal disease;
- Are currently undergoing treatment for cancer or have received chemotherapy or radiotherapy in the past 12 months;
- Regularly consume dietary supplements or functional foods high in anthocyanins or betalains that cannot be discontinued during the study period;
- Have allergies or intolerances to the intervention ingredients (e.g. pitaya, plum, raspberry);
- Are pregnant, planning to become pregnant, or currently breastfeeding;
- Are currently participating in another clinical trial or have participated in one within the last 30 days;
- Are unable or unwilling to comply with the study protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/09/2025
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Actual
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Date of last participant enrolment
Anticipated
28/11/2025
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Actual
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Date of last data collection
Anticipated
5/01/2026
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Actual
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Sample size
Target
45
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
319521
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University
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Name [1]
319521
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University of Wollongong - UOW Partnership grant
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Address [1]
319521
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Country [1]
319521
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
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Country
Australia
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Secondary sponsor category [1]
322032
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Commercial sector/Industry
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Name [1]
322032
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QGBIO+
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Address [1]
322032
0
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Country [1]
322032
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318095
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University of Wollongong Health and Medical Human Research Ethics Committee
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Ethics committee address [1]
318095
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https://www.uow.edu.au/research-and-innovation/researcher-support/ethics/human-ethics/
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Ethics committee country [1]
318095
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Australia
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Date submitted for ethics approval [1]
318095
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21/05/2024
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Approval date [1]
318095
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30/07/2024
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Ethics approval number [1]
318095
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2024/168
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Summary
Brief summary
This pilot study will investigate whether consuming purple and red-rich fruits can improve inflammation, oxidative stress, adiponectin levels, and memory in adults living with obesity. Over six weeks, participants will be randomly assigned to consume red dragon fruit juice (rich in betalains), Queen Garnet plum extract (rich in anthocyanins), or a placebo drink. Blood samples will be analysed for markers of inflammation (e.g. TNF-a, IL-6), oxidative stress, and adiponectin. Cognitive function, mood, and clinical health indicators will also be assessed. The results may help clarify the potential benefits of natural fruit compounds for metabolic and brain health.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Karen Charlton
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Address
143102
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School of Medical, Indigenous and Health Sciences, Building 41, University of Wollongong, Northfields Avenue, Wollongong, NSW 2522, Australia
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Country
143102
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Australia
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Phone
143102
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+61 02 4221 4754
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Fax
143102
0
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Email
143102
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[email protected]
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Contact person for public queries
Name
143103
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Karen Charlton
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Address
143103
0
School of Medical, Indigenous and Health Sciences, Building 41, University of Wollongong, Northfields Avenue, Wollongong, NSW 2522, Australia
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Country
143103
0
Australia
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Phone
143103
0
+61 02 4221 4754
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Fax
143103
0
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Email
143103
0
[email protected]
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Contact person for scientific queries
Name
143104
0
Karen Charlton
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Address
143104
0
School of Medical, Indigenous and Health Sciences, Building 41, University of Wollongong, Northfields Avenue, Wollongong, NSW 2522, Australia
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Country
143104
0
Australia
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Phone
143104
0
+61 02 4221 4754
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Fax
143104
0
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Email
143104
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
Download to PDF