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Trial registered on ANZCTR


Registration number
ACTRN12618000630213
Ethics application status
Approved
Date submitted
18/04/2018
Date registered
20/04/2018
Date last updated
7/07/2021
Date data sharing statement initially provided
7/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying the efficacy of the plant-origin flavonoid rutin in 2 doses (250mg and 500mg) and 2 delivery forms (yoghurt and capsules)
Scientific title
Comparison the pharmocokinetics properties of 2 doses of rutin (250mg and 500mg) in 2 delivery forms (yoghurt and capsules) in 6 healthy participants
Secondary ID [1] 294628 0
None
Universal Trial Number (UTN)
U1111-1206-1915
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 307466 0
Condition category
Condition code
Metabolic and Endocrine 306552 306552 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacokinetics (PK) Study (one off dosing, 2 weeks wash-out)
Rutin (250mg) enriched yogurt
Rutin (500mg) enriched yogurt
Rutin (250mg) in capsule
Rutin (500mg) in capsules

All participants take all deliery forms of rutin.
Each capsule contain 250mg rutin, 1 capsule for the 250mg and 2 capsules for the 500mg.
The rutin dose administration will be taken in no particular order and is randomised.
The whole study will be monitor by direct observation by a research staff.
Intervention code [1] 300932 0
Prevention
Comparator / control treatment
No control group
Control group
Dose comparison

Outcomes
Primary outcome [1] 305554 0
Plasma rutin from PK Study:
Time to reach maximum concentration
Maximum plasma concentration
Terminal elimination half-life
Timepoint [1] 305554 0
Time 0min , 5min, 10min, 20min, 40min, 60min, 90min, 120min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 20h, 24h.
There is no primary endpoint for PK study.
Time 0min is the time for the administration of the rutin dose. All time points in mins and hrs are post-ingestion of the rutin dose.
Secondary outcome [1] 345738 0
Plasma rutin from PK Study:
Area under the concentration curve
Clearance/bioavailability
Volume of distribution/bioavailability
Terminal elimination rate constant
Timepoint [1] 345738 0
Time 0min, 5min, 10min, 20min, 40min, 60min, 90min, 120min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 20h, 24h

Time 0min is the time for the administration of the rutin dose. All time points in mins and hrs are post-ingestion of the rutin dose.
Secondary outcome [2] 345739 0
Urine rutin concentration from PK Study
Timepoint [2] 345739 0
Pooled urine samples collected from 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-16, 16-20, 20-24h

Time 0 is the time for the administration of the rutin dose. All time points are post-ingestion of the rutin dose.

Eligibility
Key inclusion criteria
• Aged between 18-65 years
• BMI between 23-35 kg/m2
• Fasting plasma glucose (FPG) < 5.6 mmol/L
• Healthy, as per self-report
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Type 2 or type 1 diabetes
• Other significant disease including cardiovascular disease, pancreatic disease or cancer; or digestive disease including inflammatory bowel syndrome/disease (IBS/D), ulcerative colitis (UC), Crohn's disease
• Medications controlling glycaemia
• Current use of rutin or quercetin supplements
• Recent body weight loss/gain >10% within previous 3 months or taking part in an active diet program; or current medications for weight loss
• Dislike or unwilling to consume food items included in the study, or hypersensitivities or allergies to these foods, i.e. rutin allergy, lactose intolerant, does not consume yogurt
• Pregnant or breastfeeding women
• Unwilling/unable to comply with study protocol
• Concurrent participation in other clinical studies, or such participation within the last 3 months

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)
Allocation is concealed - done centrally based on the sequence generated by Latin square design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based upon a Latin square design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
12/12/2022
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 10338 0
New Zealand
State/province [1] 10338 0
Auckland

Funding & Sponsors
Funding source category [1] 299244 0
Government body
Name [1] 299244 0
NZ government National Science Challenge
Country [1] 299244 0
New Zealand
Primary sponsor type
University
Name
University of Auckland Research Office
Address
Level 10, Building 620
49 Symonds St
Auckland 1010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 298518 0
None
Name [1] 298518 0
None
Address [1] 298518 0
None
Country [1] 298518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300166 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 300166 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300166 0
New Zealand
Date submitted for ethics approval [1] 300166 0
15/03/2018
Approval date [1] 300166 0
10/04/2018
Ethics approval number [1] 300166 0
18/CEN/52

Summary
Brief summary
The effect of dose and form of rutin delivery on pancreatic function has not been previously studied. As part of National Science Challenge (NSC) - High Value Nutrition (HVN) Metabolic program, the trial will assess pharmacokinetics of 2 doses; 250 and 500 mg rutin (once a day), in 2 delivery methods;
encapsulated and in a food, in a crossover study over 24 hr in 6 healthy male and female participants. They will be a randomised to receive each treatment (rutin capsule, 250 mg; rutin capsule, 500 mg; yogurt with rutin 250 mg; yogurt with rutin 500 mg) with 2 week washout between treatments. Participants can complete 2 x encapsulated rutin or 2 x enriched food rutin; or all 4 treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82758 0
Prof Sally Poppitt
Address 82758 0
University of Auckland Human Nutrition Unit, 18 Carrick Place, Mt Eden, Auckland 1024
Country 82758 0
New Zealand
Phone 82758 0
+6496305160
Fax 82758 0
Email 82758 0
[email protected]
Contact person for public queries
Name 82759 0
Ivana Sequeira
Address 82759 0
University of Auckland Human Nutrition Unit, 18 Carrick Place, Mt Eden, Auckland 1024
Country 82759 0
New Zealand
Phone 82759 0
+6496301162
Fax 82759 0
Email 82759 0
[email protected]
Contact person for scientific queries
Name 82760 0
Ivana Sequeira
Address 82760 0
University of Auckland Human Nutrition Unit, 18 Carrick Place, Mt Eden, Auckland 1024
Country 82760 0
New Zealand
Phone 82760 0
+6496301162
Fax 82760 0
Email 82760 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12465Study protocol    374925-(Uploaded-27-03-2020-12-05-19)-Study-related document.docx
12466Informed consent form    374925-(Uploaded-27-03-2020-12-07-33)-Study-related document.docx
12467Ethical approval    374925-(Uploaded-05-05-2020-13-22-34)-Study-related document.pdf



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.