Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000656235
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
24/04/2018
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Date results information initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of rutin on insulin secretion in prediabetes
Scientific title
Identifying the efficacy of the plant-origin flavonoid rutin and targeting amylin to restore insulin secretion and prevent progression to diabetes in prediabetic participants
Secondary ID [1] 293931 0
None
Universal Trial Number (UTN)
U1111-1206-1915
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 306419 0
Condition category
Condition code
Metabolic and Endocrine 305507 305507 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rutin Intervention Study (daily for 12 weeks)
Arm 1: Rutin (5o0mg) enriched yoghurt (200g) + control capsules (2x 250mg)
Arm 2: Control yoghurt (200g) + rutin 500mg capsule (2x 250mg)

OGTT will take place at baseline and 12 weeks.
Participants will be fasted for 10-12hrs prior to each study visit.
Participants will be asked to bring back the lids from the yoghurt pottles and the bottle containing capsules to check for compliance at each visit.
Yoghurt will be consumed in one setting in a pottle with 200g yoghurt (enriched with 500mg rutin).
Control yoghurt will be plain yoghurt with vanilla custard flavour. The rutin-enriched yoghurt is also vanilla custard flavour.
Intervention code [1] 300198 0
Prevention
Comparator / control treatment
Control yoghurt + control capsules

Each control capsule contains 250mg maltodextrin. Pariticipants will take 500mg daily (2 capsules)
Control group
Placebo

Outcomes
Primary outcome [1] 304640 0
Pancreatic beta cell insulin secretion assessed as incremental area under the curve for C-peptide and glucose during OGTT from Intervention Study. C-peptide and glucose will be assessed using blood collected during OGTT.
Timepoint [1] 304640 0
OGTT will occur at baseline and 12 weeks post commencement of study. Assessments on these days will occur at time 0min, 30min, 60min, 90min, 120min (primary endpoint).
Secondary outcome [1] 345554 0
Fasted blood samples from Intervention Study:
HbA1c
Timepoint [1] 345554 0
Fasted blood samples will be taken at baseline and 12 weeks post commencement of study
Secondary outcome [2] 345555 0
Blood samples from Intervention Study:
Glucose
Timepoint [2] 345555 0
OGTT will occur at baseline and 12 weeks post commencement of study. Assessments on these days will occur at time 0min, 30min, 60min, 90min, 120min.
Secondary outcome [3] 345556 0
Blood samples from Intervention Study:
Insulin
Timepoint [3] 345556 0
OGTT will occur at baseline and 12 weeks post commencement of study. Assessments on these days will occur at time 0min, 30min, 60min, 90min, 120min.
Secondary outcome [4] 345557 0
Blood samples from Intervention Study:
C-peptide
Timepoint [4] 345557 0
OGTT will occur at baseline and 12 weeks post commencement of study. Assessments on these days will occur at time 0min, 30min, 60min, 90min, 120min.
Secondary outcome [5] 345558 0
Blood samples from Intervention Study:
Amylin
Timepoint [5] 345558 0
OGTT will occur at baseline and 12 weeks post commencement of study. Assessments on these days will occur at time 0min, 30min, 60min, 90min, 120min.
Secondary outcome [6] 345559 0
Fasted blood samples from Intervention Study:
Full lipid profile (cholesterol, triglycerides, LDL-C, HDL-C)

Full lipid profile will be assessed from blood collected.
Timepoint [6] 345559 0
Fasted blood samples will be taken at baseline and 12 weeks post commencement of study.
Secondary outcome [7] 345560 0
Fasted blood samples from Intervention Study:
Cytokines (Il-6, TNF, IFN)

Cytokines will be assessed from blood collected.
Timepoint [7] 345560 0
Fasted blood samples will be taken at baseline and 12 weeks post commencement of study.
Secondary outcome [8] 345561 0
Fasted blood samples from Intervention Study:
hsCRP
Timepoint [8] 345561 0
Fasted blood samples will be taken at baseline and 12 weeks post commencement of study.
Secondary outcome [9] 345562 0
Fasted blood samples from Intervention Study:
Adiponectin
Timepoint [9] 345562 0
Fasted blood samples will be taken at baseline and 12 weeks post commencement of study.

Eligibility
Key inclusion criteria
• Aged between 18-65 years
• BMI between 23-35kg/m2
• Fasting plasma glucose (FPG) greater than or equal to 5.6 – 6.9 mmol/L
• FINDRISC greather than or equal to 12
• Otherwise healthy by self-report
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Power calculation for the Intervention study was conducted using SYSTAT 13 (Systat Software Inc., Chicago, IL) and was based on a known mean (±SD) adult incremental area under the curve of C-peptide: glucose (0.53 nmol/mmol ± 0.23) following a standard 75g oral glucose tolerance test (OGTT). A sample size of 81 participants in total would have at least 80% power at 5% level of significance to detect a 20% difference in pancreatic ß cell function.
With an estimated 10% dropout rate, a total sample size of 93 participants, 31 participants per group, will be recruited in the Intervention Study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2018
Actual
30/06/2018
Date of last participant enrolment
Anticipated
21/12/2018
Actual
31/01/2019
Date of last data collection
Anticipated
21/06/2019
Actual
30/04/2019
Sample size
Target
93
Accrual to date
Final
87
Recruitment outside Australia
Country [1] 9543 0
New Zealand
State/province [1] 9543 0
Auckland

Funding & Sponsors
Funding source category [1] 298560 0
Government body
Name [1] 298560 0
NZ government National Science Challenge
Country [1] 298560 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] 297708 0
None
Name [1] 297708 0
None
Address [1] 297708 0
None
Country [1] 297708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299527 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 299527 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299527 0
New Zealand
Date submitted for ethics approval [1] 299527 0
15/03/2018
Approval date [1] 299527 0
10/04/2018
Ethics approval number [1] 299527 0
18/CEN/52

Summary
Brief summary
As part of National Science Challenge (NSC) - High Value Nutrition (HVN) Metabolic program, the trial will investigate the efficacy of 500 mg rutin, in a double blind randomised 3arm placebo controlled parallel study over 6 months in male and female participants, with demonstrated prediabetes (fasting plasma glucose: = 5.6-6.9mmol/
L). Each participant will be required to consume once daily either: yogurt control +
capsule control OR yogurt with 500 mg rutin + capsule control OR capsule 500 mg rutin + yogurt control, as part of their breakfast meal or as a later snack.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80730 0
Prof Sally Poppitt
Address 80730 0
University of Auckland Human Nutrition Unit, 18 Carrick Place, Mt Eden, Auckland 1024
Country 80730 0
New Zealand
Phone 80730 0
+6496305160
Fax 80730 0
Email 80730 0
[email protected]
Contact person for public queries
Name 80731 0
Mr Wilson Yip
Address 80731 0
University of Auckland Human Nutrition Unit, 18 Carrick Place, Mt Eden, Auckland 1024
Country 80731 0
New Zealand
Phone 80731 0
+6496301162
Fax 80731 0
Email 80731 0
[email protected]
Contact person for scientific queries
Name 80732 0
Mr Wilson Yip
Address 80732 0
University of Auckland Human Nutrition Unit, 18 Carrick Place, Mt Eden, Auckland 1024
Country 80732 0
New Zealand
Phone 80732 0
+6496301162
Fax 80732 0
Email 80732 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
9197Informed consent form  [email protected] 374418-(Uploaded-22-03-2020-07-42-55)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Stats analysis are underway, results will be updat... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a 12-Week Polyphenol Rutin Intervention on Markers of Pancreatic beta-Cell Function and Gut Microbiota in Adults with Overweight without Diabetes.2023https://dx.doi.org/10.3390/nu15153360
N.B. These documents automatically identified may not have been verified by the study sponsor.