Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000088246
Ethics application status
Approved
Date submitted
24/11/2017
Date registered
19/01/2018
Date last updated
19/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the impact of curcumin on metabolic and inflammatory markers in healthy men
Scientific title
Measuring postprandial inflammatory and metabolic markers in blood to assess the health impact of curcumin or turmeric in healthy male participants after a fatty meal
Secondary ID [1] 293356 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic disorder 305476 0
Condition category
Condition code
Diet and Nutrition 304731 304731 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 26 participants will attend in groups of 1-4. Each participant will be invited to attend 4 study visits with a washout period of ~7 days. In each of the study visits, participants will arrive at the Human Nutirtion Research Unit either in Auckland or Palmerston North, Massey university. They will be given a meal containing potatoes and 40g of fat from cream, Each meal will also contain 1 of 4 ingredients:

A= raw turmeric
B= turmeric powder
C= curcumin powder
D= no curcumin or turmeric

The meals will be equivalent to 400mg of curcumin and matched for moisture and dry weight (using corn starch). All meals contain around 550 kcals (foodworks 9, 2016 NZ food files).

A cannula will be inserted into the forearm of the participant and blood will be taken before the meal is consumed or every hour for 6 hours after the meal is consumed.

The participants will also be asked to fill out an appetite assessment questionnaire before and after the meal is consumed.

The blood will be collected from a cannula by an experienced Massey University staff member
Intervention code [1] 299614 0
Treatment: Other
Comparator / control treatment
Since this is a crossover design trial, each participant will serve as their own control. The control meal will contain potatoes and cream without any turmeric or curcumin
Control group
Placebo

Outcomes
Primary outcome [1] 303946 0
Measure the bioavailabilty of curcumin in the blood (using Cmax and AUC) as assessed by HPLC
Timepoint [1] 303946 0
0, 1, 2,3, 4 and 6 hours post meal
Primary outcome [2] 303954 0
Measure blood triglyceride level (using Cmax and AUC) as assessed by Medlab central Palmerston North
Timepoint [2] 303954 0
0, 1, 2,3, 4 and 6 hours post meal
Primary outcome [3] 303955 0
Measure hydrogen peroxide in the blood as assessed by a colorimetric assay
Timepoint [3] 303955 0
0, 1, 2,3, 4 and 6 hours [primary timepoint] post meal
Secondary outcome [1] 340534 0
Measure LPS Binding Protein levels in blood as assessed by an ELISA kit
Timepoint [1] 340534 0
0, 1, 2,3, 4 and 6 hours post meal
Secondary outcome [2] 340535 0
The assessment of appetite sensation will be done using visual analogue scales 100mm long with words at each side expressing the lowest and the highest rate
Timepoint [2] 340535 0
Before and 45 minutes after consuming the meal

Eligibility
Key inclusion criteria
• Healthy Male
• Aged between 18 and 40 years
• Normal body weight (BMI between 18 and 26 Kg/m2)
• Not allergic to spicy food
• Do not use herbal supplements
• Don’t take any medication
• Non-smokers
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Take any lipid lowering drugs or supplements or hypertensive drugs
• Are dieting or have any eating disorders and have lost more than 20 Kg weight in the last 6 months
• Have intolerance or allergy to dairy spices
• Dislike dairy or spices
• Have a history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerosis
• Have a history of diabetes, hypertension, high cholesterol
• Have a history of gastrointestinal disorder or liver disease
• Recently donated blood or have fear of needles

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)
Since this is a crossover trial, allocation concealment is not applicable. All participants will consume all 4 meals in separate visits.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which the meals will be given to participants will be determined using 4 pre-generated unique sequences. Each participant will be randomly allocated to one of the 4 sequences using simple randomization generated from a calculator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
The sample size was calculated using G*power (version 3.1.9.2) a priori, 2-tailed t-test, difference between 2 dependent means. The sample size was calculated using an anticipated mean difference between time to maximum postprandial chylomicron triglyceride levels and a standard deviation of 101.6 which was assumed based on a previous study. Based on the calculated effect size, 90% power with a level of significance of 0.05 a minimum of 23 participants would be required for each interventional treatment. Allowing for 10% dropouts and non-compliant participants, we will recruit n=26 male participants for each study.

We will be using area under the curve, Cmax, T-test, anova and repeated measure analysis to measure statistical significance

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 9359 0
New Zealand
State/province [1] 9359 0

Funding & Sponsors
Funding source category [1] 297980 0
Other
Name [1] 297980 0
Riddet Centre of Research Excellence
Country [1] 297980 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country
New Zealand
Secondary sponsor category [1] 297048 0
None
Name [1] 297048 0
Address [1] 297048 0
Country [1] 297048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299021 0
Massey University Human Ethics Committee
Ethics committee address [1] 299021 0
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Ethics committee country [1] 299021 0
New Zealand
Date submitted for ethics approval [1] 299021 0
26/02/2017
Approval date [1] 299021 0
27/03/2017
Ethics approval number [1] 299021 0
SOA 17/10

Summary
Brief summary
The main aim of this study is to investigate if there is a difference in how the bioactive compound curcumin behaves in isolation compared to when it is within turmeric. To test this we will be undertaking a single meal crossover study in healthy male participants and fat-induced blood markers measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79014 0
Dr Noha Ahmed Nasef
Address 79014 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 79014 0
New Zealand
Phone 79014 0
+6469519421
Fax 79014 0
Email 79014 0
[email protected]
Contact person for public queries
Name 79015 0
Noha Ahmed Nasef
Address 79015 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 79015 0
New Zealand
Phone 79015 0
+6469519421
Fax 79015 0
Email 79015 0
[email protected]
Contact person for scientific queries
Name 79016 0
Noha Ahmed Nasef
Address 79016 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 79016 0
New Zealand
Phone 79016 0
+6469519421
Fax 79016 0
Email 79016 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.