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Trial registered on ANZCTR

Registration number

ACTRN12617000713392

Ethics application status

Approved

Date submitted

9/05/2017

Date registered

17/05/2017

Date last updated

17/05/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Metabolic effects of consuming carbonated water or kiwifruit on a daily basis over seven-weeks

Scientific title

The effect on healthy adults of consuming a kiwifruit preload on glucose and lipid metabolism

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1196-3977

Trial acronym

Linked study record

Health condition

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

Hyperinsulinaemia

Hyperglycaemia

Blood lipids

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This will be a parallel randomized trial of two groups over seven-weeks. One group will consume two gold kiwifruit and 500mL carbonated water as a preload to breakfast each day (consumed within the 30 minutes leading up to breakfast). Prior to the intervention, participants’ normal breakfasts will be characterized by asking them to fill in weighed breakfast records for 7 days. The intervention will involve reducing breakfast by an amount equivalent to the carbohydrate contained in the gold kiwifruit preload. For example, if a person ate two slices of jam on toast for breakfast, one of those slices would be replaced by gold kiwifruit. This strategy may produce measurable benefit to metabolic markers over seven weeks; sufficient time for changes in lipids and glycaemic markers to occur. We will obtain breakfast records and train people how to substitute part of their breakfast with the gold kiwifruit. If the habitual breakfast contains fat, this will be removed propotionately with amount of CHO that is substituted with gold kiwifruit, providing a mechanism by which blood lipids would be affected. To monitor adherence we will record kiwifruit/carbonated water collection visits and obtain diet records during the intervention period. This intervention will be conducted by a postgraduate student with a Master of Science in Human Nutrition as part of her PhD with supervision by senior university and Crown Research Institute staff.

Intervention code [1]

Lifestyle

Comparator / control treatment

The comparison group will consume 500 mL carbonated water as a preload to their habitual breakfast each day (consumed within the 30 minutes leading up to breakfast) to encourage compliance, while water is unlikely to have an effect on lipids and glucose.

Control group

Active

Outcomes

Primary outcome [1]

Between group difference in fasting plasma insulin concentration, adjusted for baseline, using blood obtained via venipuncture at visits 1, 2, 5, and 6. Plasma insulin will be analysed using a Roche Elecsys electrochemiluminescence immunoanalyser

Timepoint [1]

From 0 to 7 weeks

Primary outcome [2]

Between group difference in fasting blood glucose concentration, adjusted for baseline, using blood obtained via capillary at visits 1, 2, 5, and 6. Blood glucose will be measured using a Hemocue instrument.

Timepoint [2]

From 0 to 7 weeks

Secondary outcome [1]

Change in plasma total cholesterol

Timepoint [1]

From 0 to 7 weeks

Secondary outcome [2]

Change in plasma triglycerides

Timepoint [2]

From 0 to 7 weeks

Secondary outcome [3]

Change in plasma uric acid

Timepoint [3]

From 0 to 7 weeks

Secondary outcome [4]

Change in plasma metabolomics

Timepoint [4]

From 0 to 7 weeks

Eligibility

Key inclusion criteria

Healthy adults

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

fasting glucose level above the normal range (>6.0mmol/L)
a BMI >30kg/m2
have had gastrointestinal surgical procedures
have a known allergy to kiwifruit
females who are pregnant

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)

A biostatistician will randomise treatments and place these in sealed envelopes. Each time a new participant presents, the investigator will take the next envelope and open it to reveal the group allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A total of 40 participants (20 per group) would be required to detect a clinically meaningful difference of 1 standard deviation in plasma glucose and insulin concentration with 80% power and a significance level of 0.05

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

23/05/2017

Actual

Date of last participant enrolment

Anticipated

27/06/2017

Actual

Date of last data collection

Anticipated

29/09/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

High Value Nutrition

Address [1]

Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand

Country [1]

New Zealand

Primary sponsor type

Government body

Name

Plant & Food Research Limited

Address

Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4474

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Otago

Address [1]

Department of Human Nutrition
PO Box 56
Dunedin 9054

Country [1]

New Zealand

Secondary sponsor category [2]

Commercial sector/Industry

Name [2]

Zespri International Ltd

Address [2]

PO Box 4043
Mount Maunganui South
400 Maunganui Road
Mount Maunganui 3116
New Zealand

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

Human Ethics Committee
PO Box 56
Dunedin
9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/04/2017

Approval date [1]

23/04/2017

Ethics approval number [1]

H17/048

Summary

Brief summary

Kiwifruit preloads to breakfast have been found to acutely modify the postprandial blood glucose response compared with a non-preload condition. Our aim is to test whether there is a longer-term effect of kiwifruit preload on metabolic markers over 7-weeks. The intervention group will consume 2 kiwifruit and a 500mL bottle of carbonated water 30 min prior to the remainder of breakfast whilst the control group will consume carbonated water in the 30min prior to breakfast. Main outcomes will be differences in fasting plasma glucose and insulin between groups adjusted for baseline. Secondary outcomes will be differences in fasting lipids and uric acid between groups adjusted for baseline.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bernard Venn

Address

Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054

Country

New Zealand

Phone

+6434795068

Fax

[email protected]

Contact person for public queries

Name

John Monro

Address

Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North
4474

Country

New Zealand

Phone

+646953 7700

Fax

[email protected]

Contact person for scientific queries

Name

John Monro

Address

Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North
4474

Country

New Zealand

Phone

+646953 7700

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			372897-(Uploaded-21-04-2021-06-42-09)-Basic results summary.xlsx

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Metabolic and Blood Pressure Effects of Consuming Two Kiwifruit Daily for 7 Weeks: A Randomised Controlled Trial.	2022	https://dx.doi.org/10.3390/nu14132678

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically