Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001560280
Ethics application status
Approved
Date submitted
6/09/2018
Date registered
18/09/2018
Date last updated
21/08/2020
Date data sharing statement initially provided
21/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Prickly Pear fruit consumption on postprandial blood lipids and Physiological Responses
Scientific title
The effect of Prickly Pear (Opuntia ficus indica) fruit juice consumption on postprandial lipid and physiological responses in healthy males
Secondary ID [1] 296022 0
None.
Universal Trial Number (UTN)
U1111-1220-0785
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Broadly-hypercholesterolemia 309553 0
Broadly-Hyperlipidemia 309656 0
Broadly- risk factors of Metabolic syndrome 309657 0
Broadly- risk factors of Cardiovascular disease 309658 0
Condition category
Condition code
Diet and Nutrition 308375 308375 0 0
Other diet and nutrition disorders
Cardiovascular 308458 308458 0 0
Hypertension
Cardiovascular 308459 308459 0 0
Other cardiovascular diseases
Metabolic and Endocrine 308460 308460 0 0
Other metabolic disorders
Metabolic and Endocrine 308461 308461 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to investigate the effects of single-dose Prickly Pear (Opuntia ficus indica; Australian grown) fruit juice consumption, standardised for Total betalain Content (TBC), on CVD risk factors in postprandial blood lipids and physiological responses in healthy males. This double-blind placebo-controlled trial, with wash-out period of a week, will model the potential blood lipid lowering effect of Prickly Pear fruit juice in combination with a ‘meal-model’ (high-fat muffin; Kings College UK; consumed 10 min prior) on CVD risk factors in healthy humans.

Dose: 250ml of Juice (45mg/TBC), with High-Fat muffin meal (691 KCAL;6.44 PRO; 50.4 FAT; 56.1 CHO; As per Kings College, UK)

Duration: Single consumption, 2 clinics (randomised other: placebo)

Form: Blinded juice, Liquid

Delivery: Face to face, provided by Chief investigator, blinded to both CI and participant

Location: Certified Blood Collection Room, University of Canberra, Australia
Intervention code [1] 312359 0
Treatment: Other
Intervention code [2] 312365 0
Lifestyle
Comparator / control treatment
Each participant with receive both treatment and placebo, in combination with muffin-meal during the two allocated clinics, where the order will be randomised. The placebo to Prickly Pear juice is a combination of water and commercially available food colourings and erythritol sweetener. The active and placebo will be served as the same volume (250ml) in disposable coloured cups, where the liquid is not visible, although the placebo is colour matched.
Control group
Placebo

Outcomes
Primary outcome [1] 307354 0
Postprandial lipid status (Composite-Total Cholesterol; Total Triglyceride, High-Density Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C), Very Low-Density Lipoprotein-Cholesterol (VLDL-C); ELISA Kits and Friedwald Equation)
Timepoint [1] 307354 0
Single consumption; Blood collection and physiological responses at 0,1, 2 and 3 hours
Primary outcome [2] 307446 0
Physiological responses (Composite-Blood Pressure (SBP, DBP), Heart Rate Variability (HRV), Pulse Wave Velocity (PWV), Respiratory Exchange Ratio (RER))
Timepoint [2] 307446 0
Single consumption; Blood collection and physiological responses at 0,1, 2 and 3 hours
Secondary outcome [1] 351571 0
Associated digestion indicators (Composite-Glucose, Insulin, Nitric Oxide (NO) and Antioxidant characteristics/changes (DPPH, CUPRAC, FRAP, ABTS; ELISA Kits; as per protocol)
Timepoint [1] 351571 0
Single consumption; Blood collection and physiological responses at 0,1, 2 and 3 hours

Eligibility
Key inclusion criteria
Participants will be included if they are: male; aged between 18-65; a BMI of 18.5-25; no history of cardiovascular disease or known risk factors of CVD (i.e. high cholesterol, high blood pressure, diabetes, obesity, physical inactivity and history of smoking), hepatic, gastrointestinal or renal diseases; not allergic or intolerant to dairy, egg, wheat (gluten), maize (corn); and do not adhere to vegetarian (no egg and/or dairy) or vegan diets.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recruited participants are to be excluded under the following circumstances, to ensure the participants safety.
Exclusion Criteria
Participants will be excluded from the study if they are; not with in a BMI of 18.5-25; have a history of cardiovascular disease; have self-reported/known risk factors of CVD (i.e. high cholesterol, high blood pressure, diabetes, obesity, physical inactivity and history of smoking), hepatic, gastrointestinal or renal diseases; use medications or supplements including antibiotics; lipid-lowering therapies such as; statins, fibrates (including clofibrate and ciprofibrate) and lipid-lowering therapies (ezetimibe, colesevelam, torcetrapib, avasimibe, implitapide, niacin aspirin and clopidogrel therapy, Angiotensin-Converting Enzyme (ACE/ABC) therapy) within the 6 weeks prior to clinic 1. Additionally, participants will be excluded in cases where participants are suffering with substance abuse or use tobacco products.

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)
A third-party researcher will randomise participants for treatment order (placebo, treatment; treatment, placebo) using the permuted blocks randomisations design ensuring balances groups. The key will be stored in individual sealed envelopes in a locked cabinet in a lockable room at the University. Once all the measurements have been completed, blinding will be broken to code cases where participants have consumed the placebo drink or the active Prickly Pear juice
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A third-party researcher will randomise participants for treatment order (placebo, treatment; treatment, placebo) using the permuted blocks randomisations design ensuring balances 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
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Once all the measurements have been completed, blinding will be broken to code cases where participants have consumed the placebo drink or the active Prickly Pear juice. Data will be analysed using descriptive statistics generated using Statistical Software for Social Sciences (‘SPSS’; Version 23). Comparisons will be drawn between the effects of Prickly Pear fruit juice or ‘placebo drink’ based on the individual physiological or biochemical responses measured via a One-way-ANOVA. Significance between comparison between ‘active’ and placebo measures will be investigated using a paired Student’s t test, where the significance will be set at 95%. A comparison between ‘active’ and placebo products will determine the significance of the observed responses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2018
Actual
18/09/2019
Date of last participant enrolment
Anticipated
31/07/2019
Actual
15/11/2019
Date of last data collection
Anticipated
1/12/2019
Actual
22/11/2019
Sample size
Target
23
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 300612 0
University
Name [1] 300612 0
University of Canberra: Higher Degree By Research (PhD) Allocated funding
Country [1] 300612 0
Australia
Primary sponsor type
University
Name
Faculty of Health
Address
University Drive, University of Canberra, Bruce, Canberra, ACT, 2617
Country
Australia
Secondary sponsor category [1] 300118 0
None
Name [1] 300118 0
x
Address [1] 300118 0
x
Country [1] 300118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301401 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 301401 0
Ethics committee country [1] 301401 0
Australia
Date submitted for ethics approval [1] 301401 0
06/08/2018
Approval date [1] 301401 0
31/08/2018
Ethics approval number [1] 301401 0
20181503

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

Contacts
Principal investigator
Name 86874 0
Ms Caroline Gouws
Address 86874 0
University Drive, University of Canberra Hospital, ACT 2617
Country 86874 0
Australia
Phone 86874 0
+61 411349104 (Country Code +61, Number: 0411349104)
Fax 86874 0
Email 86874 0
[email protected]
Contact person for public queries
Name 86875 0
Caroline Gouws
Address 86875 0
University Drive, University of Canberra Hospital, ACT 2617
Country 86875 0
Australia
Phone 86875 0
+61 411349104 (Country Code +61, Number: 0411349104)
Fax 86875 0
Email 86875 0
[email protected]
Contact person for scientific queries
Name 86876 0
Caroline Gouws
Address 86876 0
University Drive, University of Canberra Hospital, ACT 2617
Country 86876 0
Australia
Phone 86876 0
+61 411349104 (Country Code +61, Number: 0411349104)
Fax 86876 0
Email 86876 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.