ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1278-8201

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prediabetes

Metabolic Syndrome

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Metabolic and Endocrine

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]

Treatment: Other

Intervention code [2]

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]

The primary outcome will be change in HbA1c as measured by finger prick sampling using a Cobas 101 cartridge.

Timepoint [1]

Participants will have their HbA1c measured at baseline (visit 1) and after 12 weeks of supplementation.

Primary outcome [2]

Fasting glucose will be measured by fingerprick blood sampling using a caresens dual handheld glucometer, with testing strips and lancets for fingerprick.

Timepoint [2]

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]

Lipid profile as measured by finger prick sampling using a Cobas 101 cartridge.

Timepoint [1]

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]

Blood pressure will be monitored using a portable blood pressure cuff.

Timepoint [2]

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]

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]

12 weeks post intervention (study visit 2)

Secondary outcome [4]

Body Composition will be measured via bioelectrical impedance analysis.

Timepoint [4]

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?

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

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Massey University School of Health Sciences

Address [1]

Massey University,
PO Box 756,
Wellington 6140

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

03/06/2022

Approval date [1]

28/06/2022

Ethics approval number [1]

2022 EXP 11682

Summary

Brief summary

People with prediabetes have impaired glucose tolerance and a 70% chance of progressing to type 2 diabetes mellitus during their lifetime. Early detection of prediabetes and introduction of appropriate interventions can reverse symptoms and delay the onset of T2DM, improving quality of life and health outcomes. Foods rich in polyphenols and other bioactive compounds can improve blood glucose control in healthy subjects and people living with T2DM. 
Beetroot is high in both dietary nitrate and phytochemicals. Nitric oxide can be derived from dietary nitrate and helps mediate glucose uptake in the intestines and skeletal muscle, meaning it has an important role in regulation of blood glucose. Blackcurrants are high in the anthocyanin subclass of polyphenols which may modify blood glucose regulation through increasing insulin sensitivity.
Previous research has shown that regular consumption of foods high in anthocyanins and polyphenols such as black tea and berries can improve biomarkers of glycaemic control and glucose metabolism such as 2-h postprandial glucose, HbA1c, fasting insulin, fasting blood sugar and insulin sensitivity. Furthermore, chronic supplementation with dietary nitrate has been shown to improve insulin sensitivity and glucose control in a rat model, however we are unaware of robust studies being conducted in a chronic setting in humans.

This project will be conducted at Massey University and is an intervention trial consisting of four arms. The aims of the project are: 
- To investigate the impact of chronic supplementation of beetroot and blackcurrant compounds on measures of metabolic syndrome and glucose metabolism such as HbA1c, fasting blood sugar and lipid profiles in people with prediabetes.

We hypothesise that 12 weeks of supplementation of blackcurrant anthocyanins or beetroot compounds will improve HbA1c and measures of metabolic syndrome compared to placebo.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Cameron Haswell

Address

Massey University – Albany
College of Health, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745

Country

New Zealand

Phone

+642041752779

Fax

c.haswell@massey.ac.nz

Contact person for public queries

Name

Cameron Haswell

Address

Massey University – Albany
College of Health, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745

Country

New Zealand

Phone

+642041752779

Fax

c.haswell@massey.ac.nz

Contact person for scientific queries

Name

Cameron Haswell

Address

Massey University – Albany
College of Health, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745

Country

New Zealand

Phone

+642041752779

Fax

c.haswell@massey.ac.nz

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16293	Study protocol					384150-(Uploaded-30-06-2022-11-48-32)-Study-related document.docx
16294	Informed 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.

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