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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001062314p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
12/08/2026
Date registered
Help: Date registered
27/08/2026
Date last updated
Help: Date last updated
27/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of apple extract on glycaemia in healthy adults.
Scientific title
The acute effect of an apple extract prototype product on glycaemia, in a randomised crossover study with healthy adults.
Additional trial identifiers [1] 318140 0
Nil
Universal Trial Number (UTN)
U1111-1341-1095
Trial acronym
GREEN
Related trial records

Health condition
Health condition(s) studied:
Metabolic health 343192 0
Diabetes 343193 0
Condition category
Condition code
Metabolic and Endocrine 339278 339278 0 0
Diabetes
Diet and Nutrition 339279 339279 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a four-arm, randomised, crossover, placebo-controlled study which includes four study days separated by a washout period of at least 72 hours.

The two study interventions are:

Arm 2: 100 mL water + apple extract (2 capsules each containing 0.5 g of extract) + 50 g maltodextrin (carbohydrate challenge) in 250mL water
Arm 3: 100 mL water + apple extract (2 capsules each containing 0.5 g of extract) + 75 g sucrose (carbohydrate challenge) in 250mL water

Study visits will take approximately 2.5 hours and a participant will be in the study for about 1-2 months.

By the end of the study, participants would have completed all four study arms.

Participants must consume their intervention as quickly as possible. The interventions will be delivered to participant in the Human Clinical Research Facility, face-to-face, by a member of the research team, who will supervise the participant to monitor adherence.

The participant-facing members of the research team each have 10 plus years of experience managing clinical studies.
Intervention code [1] 335026 0
Prevention
Description of the comparator or control

The two placebo arms are:

Arm 1: 100 mL water + placebo (2 capsules) + 50g maltodextrin (carbohydrate challenge) in 250mL water
Arm 4: 100 mL water + placebo (2 capsules) + 75g sucrose (carbohydrate challenge) in 250mL water

Study visits will take approximately 2.5 hours and a participant will be in the study for about 1-2 months.

By the end of the study, participants would have completed all four study arms.

Participants must consume their intervention as quickly as possible. The interventions will be delivered to participant in the Human Clinical Research Facility, face-to-face, by a member of the research team, who will supervise the participant to monitor adherence.

The participant-facing members of the research team each have 10 plus years of experience managing clinical studies.
Control group
Placebo

Outcomes
Primary outcome [1] 346505 0
Postprandial blood glucose concentration
Timepoint [1] 346505 0
Baseline (as soon as consumption of the carbohydrate begins) and 15, 30, 45, 60, 75, 90 and 120 minutes after consumption of carbohydrate. These timepoints will be assessed for each of the four interventions.
Secondary outcome [1] 466157 0
Nil
Timepoint [1] 466157 0
Nil

Eligibility
Key inclusion criteria
An individual of any sex, aged 25 - 75 years of age.

Participants must have a Body Mass Index (BMI) of 25.0-34.9 kg/m2, and a fasting blood glucose level of less than 6.1 mmol/L.
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Volunteers will be excluded if they are unwilling or unable to comply with the study procedures.

Volunteers cannot take part if they are taking part in another study at the same time.

They will also be excluded if they are allergic to (or intolerant of) apple or the constituents of the placebo capsule. Volunteers will be excluded if they are pregnant, planning to get pregnant in the near future or are breast feeding. They must not have any of the following: (i) blood-borne diseases (e.g. hepatitis), (ii) recent bacterial or viral illness, (iii) are taking medication that affects the properties of blood (e.g. blood clotting), (iv) have a strong fear or dislike of needles and/or the sight of blood (v) have a chronic illness (e.g. cancer), (vi) are taking medication for weight loss (e.g. Wegovy, Ozempic, Saxenda) or medications that affect blood sugar (e.g. diabetic medications), (vii) smoke or vape, (viii) any gastrointestinal disorders (e.g. IBS, IBD).

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 via central randomisation.
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant numbers have been set at n = 20. This exceeds the minimum number (n=10) specified by the current ISO method (ISO 26642:2010) for determination of glycaemic index and is typical of studies involving comparisons of foods.

All study data will be captured on study-specific worksheets and transcribed to an access-restricted database maintained by the Bioeconomy Science Institute (BSI). Analysed data will be presented as mean values and standard errors of the mean. Statistical significance for the comparison between timepoints and intervention groups will be assessed using Student’s t-tests. Where multiple comparisons are required, a two-way ANOVA mixed design will be applied. Where appropriate, the original data will be transformed to achieve normality and constant variance in the residuals. Statistical significance for all indices will be set at P < 0.05 with a confidence level of 95%. All statistical analyses will be completed by a statistician at BSI.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2026
Actual
Date of last participant enrolment
Anticipated
11/11/2026
Actual
Date of last data collection
Anticipated
21/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 28424 0
New Zealand
State/province [1] 28424 0

Funding & Sponsors
Funding source category [1] 322693 0
Other
Name [1] 322693 0
Bioeconomy Science Institute
Country [1] 322693 0
New Zealand
Primary sponsor type
Other
Name
Bioeconomy Science Institute
Address
Country
New Zealand
Secondary sponsor category [1] 325624 0
None
Name [1] 325624 0
Address [1] 325624 0
Country [1] 325624 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321146 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 321146 0
Ethics committee country [1] 321146 0
New Zealand
Date submitted for ethics approval [1] 321146 0
07/09/2026
Approval date [1] 321146 0
Ethics approval number [1] 321146 0

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

Contacts
Principal investigator
Name 152814 0
Dr Suman Mishra
Address 152814 0
Bioeconomy Science Institute, 23 Batchelar Road, Palmerston North, 4410
Country 152814 0
New Zealand
Phone 152814 0
+64 06 355 6146
Fax 152814 0
Email 152814 0
[email protected]
Contact person for public queries
Name 152815 0
Suman Mishra
Address 152815 0
Bioeconomy Science Institute, 23 Batchelar Road, Palmerston North, 4410
Country 152815 0
New Zealand
Phone 152815 0
+64 06 355 6146
Fax 152815 0
Email 152815 0
[email protected]
Contact person for scientific queries
Name 152816 0
Suman Mishra
Address 152816 0
Bioeconomy Science Institute, 23 Batchelar Road, Palmerston North, 4410
Country 152816 0
New Zealand
Phone 152816 0
+64 06 355 6146
Fax 152816 0
Email 152816 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.