Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000047291
Ethics application status
Approved
Date submitted
18/12/2017
Date registered
16/01/2018
Date last updated
16/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutritional supplements for prevention of type 2 diabetes - postprandial study
Scientific title
Effects of Curcumin and/or Omega 3 fatty acids on postprandial glycaemic parameters in healthy individuals.
Secondary ID [1] 293629 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 305905 0
Condition category
Condition code
Metabolic and Endocrine 305094 305094 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will visit Nutraceuticals clinical research rooms after an overnight fast of at least 10 hours. Following arrival, study participants will be randomly allocated to a single dose of these treatment arms on four visit days before receiving a standardised meal.
1. Placebo: 4 oral capsules (2 each for matching for curcumin and matching for fish oil placebos)
2. Curcumin (2 tablets @500 mg each) providing 180 mg curcumin plus 2 placebo matching for fish oil capsule
3: Fish oil (2 capsules @1000mg each) providing 1.2g EPA/DHA plus 2 placebo matching for curcumin capsules.
4: Curcumin (2 tablets @500 mg each providing a total of 180 mg curcumin) and fish oil (2 capsules @1000mg each providing a total of 1.2g EPA/DHA)
Standardised meal included: 2 toasted white bread slices, 22g of peanut spread and chocolate flavoured milk.
Participants receive treatments with a washout period of one week.
Tablets/Capsules will be provided to the participants by the study investigator and are consumed before investigator. Participants are advised consuming the meal within 20 minutes.
Intervention code [1] 299892 0
Prevention
Comparator / control treatment
Fish oil placebo - Corn oil
Curcumin Placebo - Microcrystalline cellulose and dicalcium phosphate anhydrous
Control group
Placebo

Outcomes
Primary outcome [1] 304270 0
Blood glucose level
Timepoint [1] 304270 0
60 minutes post standard meal consumption
Secondary outcome [1] 341438 0
Serum Insulin
Timepoint [1] 341438 0
fasting, 1-hour and 2-hour postprandial serum insulin levels
Secondary outcome [2] 341439 0
Serum Triglycerides
Timepoint [2] 341439 0
Fasting, 1-hour and 2-hour postprandial serum triglycerides

Eligibility
Key inclusion criteria
This study is suitable for you if:
You are aged between 18-45 years
You have body mass index (BMI) < 30 Kg/m2
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
This study is not suitable for you if you have/are :
Chronic or metabolic disease (eg: type 2 diabetes, cardiovascular disease)
Auto-immune disease (rheumatoid arthritis, type 1 diabetes, lupus)
Liver disease and Anaemia
On medications for control of blood glucose levels
Neurological diseases or seizures
On regular dietary supplements are known to influence blood glucose level
Pregnant, planning to become pregnant or breastfeeding
Difficulties in providing blood sample
Difficulties in providing informed consent
Sensitivity/ intolerance to the products involved in this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Placebo-controlled, cross-over
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/09/2017
Date of last participant enrolment
Anticipated
Actual
17/11/2017
Date of last data collection
Anticipated
Actual
22/11/2017
Sample size
Target
15
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298246 0
University
Name [1] 298246 0
University of Newcastle
Country [1] 298246 0
Australia
Funding source category [2] 298247 0
Commercial sector/Industry
Name [2] 298247 0
EPAX
Country [2] 298247 0
Norway
Funding source category [3] 298248 0
Commercial sector/Industry
Name [3] 298248 0
Indena S.p.A
Country [3] 298248 0
Italy
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 297363 0
None
Name [1] 297363 0
Address [1] 297363 0
Country [1] 297363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299254 0
Human Research Ethics Committee (HREC) - University of Newcastle
Ethics committee address [1] 299254 0
University of Newcastle Callaghan, NSW 2308 AUSTRALIA
Ethics committee country [1] 299254 0
Australia
Date submitted for ethics approval [1] 299254 0
23/08/2017
Approval date [1] 299254 0
13/09/2017
Ethics approval number [1] 299254 0
H-2014-0385

Summary
Brief summary
Postprandial (post-meal consumption) blood sugar level has been implicated in the development of obesity, type 2 diabetes and cardiovascular disease. It has been indicated that a rapid rate of rise followed by slower decline in the blood glucose levels post meal consumption are linked with fat deposition and adversely affect metabolic health. Curcumin, a bio-active ingredient obtained from the spice turmeric, is a potent anti-inflammatory agent, which is being now evaluated for its effects for controlling post meal blood sugar levels. Long chain omega 3 fatty acids (eicosapentanoic acid and docosahexaenoic acid) are established triglyceride lowering agents which are primarily obtained from fish or fish oil. The current purpose of this study is to evaluate the efficacy of a single dose of dietary supplements (curcumin and/or fish oil) on the post meal blood glucose rise in healthy individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79802 0
Prof Manohar Garg
Address 79802 0
Nutraceuticals Research Group 305C Medical Science Building University Dr University of Newcastle Callaghan, NSW 2308
Country 79802 0
Australia
Phone 79802 0
+61 2 4921 5647
Fax 79802 0
Email 79802 0
[email protected]
Contact person for public queries
Name 79803 0
Mr Rohith Thota
Address 79803 0
Nutraceuticals Research Group MS3-05 Medical Science Building University Dr University of Newcastle Callaghan, NSW 2308
Country 79803 0
Australia
Phone 79803 0
+61-2-4921 5636
Fax 79803 0
Email 79803 0
[email protected]
Contact person for scientific queries
Name 79804 0
Prof Manohar Garg
Address 79804 0
Nutraceuticals Research Group 305C Medical Science Building University Dr University of Newcastle Callaghan, NSW 2308
Country 79804 0
Australia
Phone 79804 0
+61 2 4921 5647
Fax 79804 0
Email 79804 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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