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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
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

Study type
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
Comparator / control treatment
No control group
Control group
Dose comparison

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
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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 10338 0
New Zealand
State/province [1] 10338 0

Funding & Sponsors
Funding source category [1] 299244 0
Government body
Name [1] 299244 0
NZ government National Science Challenge
Address [1] 299244 0
Building 505
85 Park Road
Auckland 1023
New Zealand
Country [1] 299244 0
New Zealand
Primary sponsor type
University of Auckland Research Office
Level 10, Building 620
49 Symonds St
Auckland 1010
New Zealand
New Zealand
Secondary sponsor category [1] 298518 0
Name [1] 298518 0
Address [1] 298518 0
Country [1] 298518 0

Ethics approval
Ethics application status
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
Ethics committee country [1] 300166 0
New Zealand
Date submitted for ethics approval [1] 300166 0
Approval date [1] 300166 0
Ethics approval number [1] 300166 0

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

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
Fax 82758 0
Email 82758 0
Contact person for public queries
Name 82759 0
Dr 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
Fax 82759 0
Email 82759 0
Contact person for scientific queries
Name 82760 0
Dr 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
Fax 82760 0
Email 82760 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 12465 0
Study protocol
Citation [1] 12465 0
Link [1] 12465 0
Email [1] 12465 0
Other [1] 12465 0
Type [2] 12466 0
Informed consent form
Citation [2] 12466 0
Link [2] 12466 0
Email [2] 12466 0
Other [2] 12466 0
Type [3] 12467 0
Ethical approval
Citation [3] 12467 0
Link [3] 12467 0
Email [3] 12467 0
Other [3] 12467 0
Summary results
No Results