Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001483448
Ethics application status
Approved
Date submitted
27/09/2016
Date registered
25/10/2016
Date last updated
20/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Curcumin and long chain omega-3 fatty acids for management of cardiovascular health in individuals with type 2 diabetes
Scientific title
Curcumin and long chain omega-3 fatty acids for management of cardiovascular health in individuals with type 2 diabetes
Secondary ID [1] 290201 0
NONE
Universal Trial Number (UTN)
Trial acronym
CALFOR-CVD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 300363 0
Condition category
Condition code
Metabolic and Endocrine 300228 300228 0 0
Diabetes
Cardiovascular 300278 300278 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will be randomly allocated to these treatment arms for 6 weeks
1) 2 X placebo tablets (matching for curcumin) + 2 X placebo capsules (matching for fish oil) per day
2) 2 X 500 mg curcumin tablets + 2 X placebo capsules (matching for fish oil) per day
3) 2 X 1000 mg fish oil capsules + 2 X placebo tablets (matching for curcumin) per day
4) 2 X 500 mg curcumin tablets + 2 X 1000 mg fish oil capsules per day
To monitor adherence to intervention,
1. Capsule intake by participants will be measured on post-intervention visit
2. Compliance to the omega 3 fatty acids will be monitored by measuring participant's erythrocyte fatty acid content
3. Adherence to curcumin will be monitored by measuring curcumin content in the participant blood sample by using HPLC method.
Intervention code [1] 295959 0
Treatment: Other
Comparator / control treatment
Fish oil placebo - Corn oil
Curcumin Placebo - Microcrystalline cellulose and dicalcium phosphate anhydrous
Control group
Placebo

Outcomes
Primary outcome [1] 299708 0
Serum Triglycerides
Serum Triglycerides will be analyzed by Hunter New England Area Pathology Services (HAPS)
Timepoint [1] 299708 0
At baseline (o day) and post intervention (42 day)
Secondary outcome [1] 327902 0
Serum Total cholesterol
Serum Total cholesterol will be analyzed by Hunter New England Area Pathology Services (HAPS)
Timepoint [1] 327902 0
At baseline(0 day) and Post intervention (42 day)
Secondary outcome [2] 327903 0
Serum HDL-Cholesterol
Serum HDL-Cholesterol will be analyzed by Hunter New England Area Pathology Services (HAPS)
Timepoint [2] 327903 0
At baseline (0 day) and post - intervention (42 day)
Secondary outcome [3] 327905 0
Fasting LDL cholesterol in blood sample Analysed by Hunter New England Area Pathology Services (HAPS)
Timepoint [3] 327905 0
At baseline (0 day) and post - intervention (42 day)
Secondary outcome [4] 327906 0
Serum Adiponectin (ELISA method)
Timepoint [4] 327906 0
At base line (0 day) and post - intervention (42 day)
Secondary outcome [5] 327907 0
C-Reactive protein in blood sample Analysed by Hunter New England Area Pathology Services (HAPS)
Timepoint [5] 327907 0
At baseline (0 day) and post-intervention (42 day)
Secondary outcome [6] 327908 0
Fasting plasma glucose levels Analysed by Hunter New England Area Pathology Services (HAPS)
Timepoint [6] 327908 0
At baseline (0 day) and post - intervention (42 day)
Secondary outcome [7] 327909 0
Fasting plasma insulin levels Analysed by Hunter New England Area Pathology Services (HAPS)
Timepoint [7] 327909 0
At baseline (0 day) and post - intervention (42 day)

Eligibility
Key inclusion criteria
This study is suitable for you if
You are aged between 40 and 75 years;
You are diagnosed with type 2 diabetes (duration less than 15 years)
Your body mass index (BMI) lies between 25 and 45 kg/m2
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study is not suitable for you if:
You are pregnant, planning to become pregnant or breastfeeding
Cannot provide informed consent
You have type 1 diabetes
You are currently on insulin treatment
You are diagnosed with cancer
You have a glomerular filtration rate less than 45
You have been diagnosed with painful peripheral neuropathy
You have a cardiac pacemaker
You have a history of severe neurological diseases (Parkinson’s, multiple sclerosis, epilepsy)
You are consuming more than 2 serves of oily fish per week
You are taking regular dietary supplements known to influence blood lipid levels
You have sensitivity/ intolerance to the products involved in this study
You are unwilling to fast for 10 hours before giving blood sample

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)
Participants will be recruited from the general public through media advertising and from GP practices. Advertisements will be placed on noticeboards at the University of Newcastle and pharmacies and distributed via departmental email lists. Participants will also be recruited from the Hunter Medical Research Institute (HMRI) Volunteer Register. Participants will complete a medical questionnaire to ensure that inclusion criteria are met. Randomization of participants to one of the intervention will be performed by one of the researchers in the research group. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of participants to one of the treatment arms will be performed by randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Factorial
Other design features
factorial, randomized, double-blinded, placebo-controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination
Based on the data of the triglyceride levels of people with type 2 diabetes from previous studies, with the mean deviation of 0.5 units in triglycerides, a sample size of seventeen participants in each treatment group will give 80% power to detect a 0.5 units drop in triglycerides at type 1 error (alpha)= 0.05. To allow for dropouts we will recruit 4x20 = 80 participants according to the inclusion criteria.
Treatment effects
Data obtained from all participants will be analyzed according to the intention to treat theory. Normality of baseline data will be examined using histograms with a normal distribution curve overlayed and Shapiro Wilk’s test. Based on the distribution of data, the outcome measures will be analyzed using ANOVA (normal distribution) or Wilcoxon signed rank test (non-parametric data). Two-way ANOVA with post hoc comparisons will be used to determine the effect of the intervention on different variables and also to determine synergistic or complementary effects of two interventions (curcumin and LCn-3PUFA). ANCOVA will be used to assess the effects of confounding factors on treatment that include age, gender, BMI physical activity levels and dietary intake. Significance will be set at P-value <0.05. Statistical analysis will be performed using GraphPad Prism version 6 and IBM SPSS 22 software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/10/2016
Date of last participant enrolment
Anticipated
1/05/2018
Actual
Date of last data collection
Anticipated
16/07/2018
Actual
Sample size
Target
80
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14354 0
2308 - Newcastle University
Recruitment postcode(s) [2] 14355 0
2310 - Hunter Region
Recruitment postcode(s) [3] 14356 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 294568 0
University
Name [1] 294568 0
University of Newcastle
Country [1] 294568 0
Australia
Funding source category [2] 294761 0
Commercial sector/Industry
Name [2] 294761 0
EPAX
Country [2] 294761 0
Norway
Funding source category [3] 294762 0
Commercial sector/Industry
Name [3] 294762 0
Indena S.p.A
Country [3] 294762 0
Italy
Primary sponsor type
University
Name
The University of Newcastle
Address
University drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 293608 0
None
Name [1] 293608 0
Address [1] 293608 0
Country [1] 293608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296002 0
Hunter New England Human Research Ethics Committe
Ethics committee address [1] 296002 0
Research Ethics & Governance Office
Locked Bag 1 New Lambton NSW
Ethics committee country [1] 296002 0
Australia
Date submitted for ethics approval [1] 296002 0
30/08/2016
Approval date [1] 296002 0
23/09/2016
Ethics approval number [1] 296002 0

Summary
Brief summary
The prevalence of type 2 diabetes (T2D) and its associated complications represents a major global health hazard. According to the Diabetes Australia, the number of individuals with T2D reached 1.7 million with 1.2 million diagnosed and registered cases. Individuals with T2D are associated with two-four fold increased the risk of cardiovascular diseases (CVD) such as stroke, peripheral vascular disease, myocardial infarction and angina pectoris. CVD accounts for more than 70% of deaths in patients with T2D. Epidemiological studies documented T2D as an independent risk factor for CVD in both men and women. Despite effective glucose control measures and advances in the management of CVD in T2D, several other chronic risk factors like high blood pressure, abnormal triglycerides, small dense LDL particles, low HDL-C and insulin resistance increase the risk of developing CVD in individuals with type 2 diabetes. T2D related changes in the plasma lipid levels are key factors among the other factors that are manageable by interventions to control the CVD risk. It is well documented that combination of high plasma triglyceride levels and low HDL-C (HDL-C2) is well associated with cardiovascular risk. The previous meta-analysis has reported that every 1mmol/L increase in triglyceride increase cardiovascular disease risk by 32% in men and 76% increase in women. Along with the triglycerides, the glycosylation and oxidation of LDL particles differ in type 2 diabetes when compared with non-diabetic individuals. Several randomized controlled trials have supported the association of the reduction of LDL-C (up to 1mmol/L) with reduced cardiovascular disease. Targeting blood lipids and inflammation in type 2 diabetes individuals who are at a high risk of developing CVD will help to resolute these modifiable risk factors and presumably reduce the overall risk of developing CVD. In the present study, we propose to evaluate the complementary and/or synergistic effects of curcumin and n-3PUFA in modulating lipid profiles (decrease in triglycerides and small dense LDL-C particles) in individuals with type 2 diabetes through a 6 weeks factorial randomised controlled trial . We also evaluate the effects of curcumin and LCn-3PUFA on secondary outcomes such as inflammation, blood glucose, and blood pressure.


Trial website
Trial related presentations / publications
Public notes
Fish oil capsules and Curcumin were provided by EPAX, Norway, and Indena, Italy at free of cost for this study. These companies have no involvement in study design, data collection or analysis.

Contacts
Principal investigator
Name 69218 0
Prof Manohar Garg
Address 69218 0
Nutraceuticals Research Group 305C Medical Science Building university drive, University of Newcastle Callaghan, NSW 2308 AUSTRALIA
Country 69218 0
Australia
Phone 69218 0
+61 2 4921 5647
Fax 69218 0
+61 2 4921 2028
Email 69218 0
[email protected]
Contact person for public queries
Name 69219 0
Mr Rohith Thota
Address 69219 0
Nutraceuticals Research Group 3-05 Medical Science Building, university drive, University of Newcastle Callaghan, NSW 2308
Country 69219 0
Australia
Phone 69219 0
+61-2-4921 5636
Fax 69219 0
+61 2 4921 2028
Email 69219 0
[email protected]
Contact person for scientific queries
Name 69220 0
Prof Manohar Garg
Address 69220 0
MS305C Nutraceuticals Research Group, university drive, University of Newcastle Callaghan, NSW 2308
Country 69220 0
Australia
Phone 69220 0
+61-2-4921 5636
Fax 69220 0
+61 2 4921 2028
Email 69220 0
[email protected]

No information has been provided regarding IPD availability


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.