Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001108707
Ethics application status
Approved
Date submitted
3/06/2022
Date registered
11/08/2022
Date last updated
31/08/2023
Date data sharing statement initially provided
11/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the effect of 12 weeks of supplementation with beetroot compounds and blackcurrant anthocynanins on glucose control in adults who are prediabetic?
Scientific title
Effects of beetroot compounds and blackcurrants anthocynanins on glucose control in prediabetes: A pilot study
Secondary ID [1] 307256 0
None
Universal Trial Number (UTN)
U1111-1278-8201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 326511 0
Metabolic Syndrome 326512 0
Condition category
Condition code
Metabolic and Endocrine 323774 323774 0 0
Diabetes
Metabolic and Endocrine 323775 323775 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive beetroot juice, blackcurrant juice, a mix, or placebo daily for 12 weeks. The beetroot juice (~67g made up to 200ml) will contain 600mg of nitrate, the blackcurrant juice (~9g made up to 50ml) 300mg of anthocyanins and the mix (~76g made up to 200ml) will contain both 600mg of nitrate and 300mg of anthocyanins.

The intervention drinks will be made up by an independent randomisation officer and participants will be asked to make the dilutions at home to decrease the quantity of juice they must store.

Adherence will be monitored by an online compliance diary to filled out weekly by the participants using Qualtrics survey software.
Intervention code [1] 323693 0
Treatment: Other
Intervention code [2] 323694 0
Prevention
Comparator / control treatment
A placebo beverage will be used as a control. The control group will receive 100ml of a purple/pink coloured blackcurrant flavoured beverage daily for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 331531 0
The primary outcome will be change in HbA1c as measured by finger prick sampling using a Cobas 101 cartridge.
Timepoint [1] 331531 0
Participants will have their HbA1c measured at baseline (visit 1) and after 12 weeks of supplementation.
Primary outcome [2] 331532 0
Fasting glucose will be measured by fingerprick blood sampling using a caresens dual handheld glucometer, with testing strips and lancets for fingerprick.
Timepoint [2] 331532 0
Fasting glucose will be measured at baseline at visit 1 and after 12 weeks during visit 2. Participants will also measure their own fasting glucose using lancets and the glucometers provided (caresens dual) once weekly for the duration of the 12 weeks:

Timepoints are:
Baseline (0 weeks)
1 week post-intervention
2 weeks post-intervention
3 weeks post-intervention
4 weeks post-intervention
5 weeks post-intervention
6 weeks post-intervention
7 weeks post-intervention
8 weeks post-intervention
9 weeks post-intervention
10 weeks post-intervention
11weeks post-intervention
12 weeks post-intervention (study visit 2).
Secondary outcome [1] 410200 0
Lipid profile as measured by finger prick sampling using a Cobas 101 cartridge.
Timepoint [1] 410200 0
Fasting lipid profiles will be measured at baseline at visit 1 and after 12 weeks of intervention during visit 2.

Timepoints are:
Baseline (0 Weeks
12 weeks post-intervention
Secondary outcome [2] 410202 0
Blood pressure will be monitored using a portable blood pressure cuff.
Timepoint [2] 410202 0
Blood pressure will be measured at baseline at visit 1 and after 12 weeks of intervention during visit 2.

Timepoints are:
Baseline (0 weeks)
12 weeks post-intervention
Secondary outcome [3] 410203 0
Feasibility will be measured via a questionnaire filled out by participants during study visit 2. The questionnaire includes questions and feedback about the palatability of the beverages and the frequency of consumption. It was designed specifically for this study, adapted from a previous study within Massey University (trial no. ACTRN12622000462785).
Timepoint [3] 410203 0
12 weeks post intervention (study visit 2)
Secondary outcome [4] 411371 0
Body Composition will be measured via bioelectrical impedance analysis.
Timepoint [4] 411371 0
Body composition will be measured at baseline at visit 1 and after 12 weeks of intervention during visit 2.

Timepoints are:
Baseline (0 weeks)
12 weeks post-intervention

Eligibility
Key inclusion criteria
• 30-65 years of age
• BMI 18.5 - 40.0 kg/ m2
• HbA1c 41-49 mmol/ mol
• Fasting glucose > 5.6 mmol/ L
• Not taking any medications that include blood glucose/sugar lowering prescriptions
• Not pregnant or breastfeeding
• Not allergic to beetroot or blackcurrant
• Non-smoker
• Able to communicate well in English
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Use insulin
• Chronic kidney disease
• Significant weight loss in previous 12 months
• Regularly participating in >5hrs exercise weekly
• On strict dietary restrictions
• Other medical factors that may affect 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)
The allocation will be concealed by the randomisation officer using numbered containers. Only the randomisation officer will know which beverages are which as all beverages will be diluted to the same quantity and are matched in colour.

The randomisation officer will also be in charge of delivering the drinks to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will take place using a sequenced randomisation generator splitting into 4 groups; A, B, C and D. The randomisation officer will be responsible for which drink adheres to which letter.

Groups will be split by age (30-50, 50-65) and gender (male and female).
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t-test analyses will be used to compare HbA1c, CRP, lipids, body composition and blood pressure before and after the twelve-week intervention. Fasting glucose samples will be compared using a one-way ANOVA with a repeated measures design. A p-value <0.05 will be considered statistically significant. Analysis will be performed using SPSS statistics software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/05/2023
Actual
31/05/2023
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
160
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 24818 0
New Zealand
State/province [1] 24818 0
Auckland

Funding & Sponsors
Funding source category [1] 311551 0
University
Name [1] 311551 0
Massey University School of Health Sciences
Country [1] 311551 0
New Zealand
Primary sponsor type
University
Name
Massey University School of Health Sciences
Address
Massey University,
PO Box 756,
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 312968 0
None
Name [1] 312968 0
Address [1] 312968 0
Country [1] 312968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311003 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 311003 0
Ethics committee country [1] 311003 0
New Zealand
Date submitted for ethics approval [1] 311003 0
03/06/2022
Approval date [1] 311003 0
28/06/2022
Ethics approval number [1] 311003 0
2022 EXP 11682

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119658 0
Mr Cameron Haswell
Address 119658 0
Massey University – Albany
College of Health, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 119658 0
New Zealand
Phone 119658 0
+642041752779
Fax 119658 0
Email 119658 0
[email protected]
Contact person for public queries
Name 119659 0
Cameron Haswell
Address 119659 0
Massey University – Albany
College of Health, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 119659 0
New Zealand
Phone 119659 0
+642041752779
Fax 119659 0
Email 119659 0
[email protected]
Contact person for scientific queries
Name 119660 0
Cameron Haswell
Address 119660 0
Massey University – Albany
College of Health, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 119660 0
New Zealand
Phone 119660 0
+642041752779
Fax 119660 0
Email 119660 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
16293Study protocol    384150-(Uploaded-30-06-2022-11-48-32)-Study-related document.docx
16294Informed consent form    384150-(Uploaded-03-06-2022-12-04-06)-Study-related document.docx



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.