Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000956505
Ethics application status
Approved
Date submitted
25/08/2015
Date registered
11/09/2015
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Date results provided
4/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Plant sterols and Curcumin for the Prevention of Cardiovascular Disease
Scientific title
Complementary and/or synergistic effects of phytosterols and curcumin on cardiovascular disease risk factors in hypercholesterolaemic adults.
Secondary ID [1] 287344 0
Nil known
Universal Trial Number (UTN)
U1111-1173-6120
Trial acronym
PAC-CVD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia 295994 0
Inflammation 295995 0
Cardiovascular disease 296086 0
Condition category
Condition code
Cardiovascular 296276 296276 0 0
Other cardiovascular diseases
Diet and Nutrition 296347 296347 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 296395 296395 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effects of dietary supplementation of 2.0g of phytosterols (phytosterol-enriched margarine) with or without curcumin (capsules) each day. This randomised control trial is a 2x2 factorial placebo-controlled design.
Hypercholesterolaemic individuals will be randomly assigned to one of the following treatment arms for 4 weeks:
Arm 1: Placebo: 25g Regular canola-based margarine spread plus placebo (2 x 500mg capsules) per day.
Arm 2: 25g Logicol margarine spread (i.e. 2g phytosterols) plus placebo (2 x 500mg capsules) per day.
Arm 3: 25g Regular canola-based margarine spread plus Curcumin (2 x 500mg capsules) per day.
Arm 4: 25g Logicol margarine spread (i.e. 2g phytosterols) and Curcumin (2x 500mg capsules) per day.

The margarine will be pre-weighed into individual containers containing the daily dosage and all of the daily dose of margarine (i.e. 25g) is to be consumed. Participants will be instructed on how to consume the margarine at their initial visit to the research clinic. The margarine is to be consumed as a regular margarine or butter spread would normally be used (i.e. spread on bread, crackers, muffins etc) however, not used for cooking or melted on top of vegetables.

To assess compliance:
1. Participants will be asked to record their daily consumption of the two intervention products in a standardised log provided to them.
2. Participants will be asked to return all margarine containers and capsule bottles at the end of the trial for record and weighing of any remaining products.
Intervention code [1] 292675 0
Treatment: Other
Intervention code [2] 292676 0
Prevention
Comparator / control treatment
Phytosterol placebo - low-fat, canola-based margarine (commercially available)
Curcumin placebo capsules - microcrystalline cellulose and dicalcium phosphate anhydrous
Control group
Placebo

Outcomes
Primary outcome [1] 295931 0
Total cholesterol concentration in blood plasma
Timepoint [1] 295931 0
At baseline (week zero) and at week 4 (end of study)
Primary outcome [2] 295932 0
Low-density lipoprotein cholesterol concentration in blood plasma
Timepoint [2] 295932 0
At baseline (week zero) and at week 4 (end of study)
Secondary outcome [1] 316947 0
Inflammatory mediators (i.e. CRP, fibrinogen, IL-6, IL-1beta, IkB, iCAM)
Timepoint [1] 316947 0
At baseline (week zero) and week 4 (end of study)
Secondary outcome [2] 316948 0
Cardiovascular Disease Risk - using the Framingham cardiovascular disease risk algorithm.
Timepoint [2] 316948 0
At baseline (week zero) and week 4 (end of study)

Eligibility
Key inclusion criteria
* Age: 18-70 years
* Gender: both males and females
* Total cholesterol levels greater than or equal to 5.5mmol/L (after a 10 hour fast)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or lactating
* History of cardiovascular events (e.g. stroke, heart attack, angina, aneurysm, hemorrhage, myocardial infarction etc)
* People with pace maker implants
* Diabetes mellitus
* A chronic inflammatory disease and/or condition (e.g. cancer)
* Hypertension
* Liver or renal disease
* Taking anti-inflammatory medications/supplements (e.g. Aspirin, Atacand, Celebrex)
* Taking hypolipidaemic medications/supplements (e.g. Lipitor, Crestor, Zocor)
* Taking regular dietary supplements known to influence blood lipid levels (e.g. fish oil, fibre, curcumin)
* Already consuming phytosterol-enriched products on a daily and/or regular basis (approximately 4 days/week)
* Strong allergies/intolerance/sensitivities or food aversions to the foods involved in this study
* History of gastric ulcers, lung and respiratory diseases
* History of severe neurological diseases or seizures
* BMI greater than 40

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)
Interested subjects will contact the study investigator who will then assess the subject's eligibility to participate over the phone. If the participant is deemed eligible, the participant will be sent a consent form, participant information statement and will be enrolled in the study. They will also be sent a series of self-administered questionnaires (medical history, physical activity, 3-day food record) along with instructions. All forms will need to be completed and returned upon baseline visit.
Allocation to treatments will be based on the computer generated block randomization method to ensure well-balanced groups. The allocation concealment will be conducted using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatments will be based on the computer generated block randomization method to ensure well-balanced groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination:
Twenty participants in a 2x2 factorial study design will give 80% power to detect a 10% drop in total cholesterol levels at alpha = 0.05. We will recruit 4x20 = 80 participants according to the inclusion criteria.

Baseline data:
Baseline measures will be used as covariates. Gender, age and other potentially confounding variables such as anthropometrics, physical activity levels, and duration of hypercholesterolaemia may be added as covariates if they are significantly correlated with the outcome measures.

Treatment effects:
All the data relating the significant effects of phytosterols and/or curcumin will be expressed as mean+/- SEM. The effect of interventions on blood lipids and pro-inflammatory markers between groups will be estimated using two-way ANOVA with post-hoc comparisons (Tukey’s significant difference). Significance (P-value set at 0.05) indicates the changes from the baseline values. Changes from baseline will be determined using non-parametric analysis (Wilcoxon’s signed ranked test). This statistical analysis will help to determine whether there will be a significant main effect for each independent variable by testing for between subject effects. The statistical analysis by this method will be performed to evaluate the synergistic effects between Phytosterols and Curcumin.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/09/2015
Actual
7/09/2015
Date of last participant enrolment
Anticipated
Actual
28/10/2016
Date of last data collection
Anticipated
Actual
2/12/2016
Sample size
Target
80
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 10204 0
2308 - Newcastle University
Recruitment postcode(s) [2] 10205 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 291905 0
Self funded/Unfunded
Name [1] 291905 0
Country [1] 291905 0
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan, NSW
2308
Country
Australia
Secondary sponsor category [1] 290574 0
None
Name [1] 290574 0
Address [1] 290574 0
Country [1] 290574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293412 0
Human Research Ethics Committee
Ethics committee address [1] 293412 0
Ethics committee country [1] 293412 0
Australia
Date submitted for ethics approval [1] 293412 0
Approval date [1] 293412 0
25/08/2015
Ethics approval number [1] 293412 0
H-2015-0162

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

Contacts
Principal investigator
Name 59822 0
Prof Manohar Garg
Address 59822 0
Nutraceuticals Research Group
305C Medical Science Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 59822 0
Australia
Phone 59822 0
+61-2-4921 5647
Fax 59822 0
+61-2-4921 2028
Email 59822 0
[email protected]
Contact person for public queries
Name 59823 0
Manohar Garg
Address 59823 0
Nutraceuticals Research Group
305C Medical Science Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 59823 0
Australia
Phone 59823 0
+61-2-4921 5647
Fax 59823 0
+61-2-4921 2028
Email 59823 0
[email protected]
Contact person for scientific queries
Name 59824 0
Manohar Garg
Address 59824 0
Nutraceuticals Research Group
305C Medical Science Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 59824 0
Australia
Phone 59824 0
+61-2-4921 5647
Fax 59824 0
+61-2-4921 2028
Email 59824 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
SourceTitleYear of PublicationDOI
EmbaseAssociation of Plasma Neurofilament Light Chain With Glycaemic Control and Insulin Resistance in Middle-Aged Adults.2022https://dx.doi.org/10.3389/fendo.2022.915449
N.B. These documents automatically identified may not have been verified by the study sponsor.