Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000747628p
Ethics application status
Submitted, not yet approved
Date submitted
15/06/2023
Date registered
10/07/2023
Date last updated
10/07/2023
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Glucoraphanin vegetable soup and blood extracellular vesicles.
Scientific title
Effects of a glucoraphanin-containing vegetable soup on the composition and functional activities of blood extracellular vesicles in healthy human volunteers
Secondary ID [1] 309876 0
None
Universal Trial Number (UTN)
U1111-1293-5125
Trial acronym
GLOBE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 330331 0
Oxidative stress 330333 0
Dietary and Nutrition disorders 330524 0
Condition category
Condition code
Diet and Nutrition 327182 327182 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 327376 327376 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will involve two randomized treatments provided as soups to the participants.
Treatment A- commercially available glucoraphanin-containing vegetable soup (1 Serving;250ml).

On the screening visit (Visit 1), height and weight will be measured using a stadiometer and a clinical body weighing scale, respectively. Waist circumference will be measured at the screening visit (Visit 1) midway between the inferior margin of the lower rib and the iliac crest using a non-stretchable metal tape.

Participants will be instructed to avoid consuming cruciferous vegetables (broccoli, spinach, cabbage, cauliflower, bok choy, brussels sprouts, collard greens) and condiments like mustard, mustard greens, horseradish, and wasabi in the 2 days (48h) preceding each treatment visit and during the treatment visits; participants will be asked to record their dietary intake for the 2 days immediately preceding the treatment visits.

After the screening visit (Visit 1), participants will be asked to attend the Clinical Research Unit (CRU) of the Liggins Institute in an overnight fasted state (10-12 hours) on 6 further occasions; Treatment visit (Visit 2 and Visit 5) and Interim Visits (Visit 3, Visit 4, Visit 6 and Visit 7), separated by a one week washout period between the two treatment visits.

Prior to treatment visits (2 and 5), participants will be asked to take dinner between 7:30 and 9 pm on the previous night before the visit, and after the dinner, they are not allowed to eat anything except water till they come over to the CRU. There is no restriction on what the participant eat for dinner, but we will request the participant to avoid eating broccoli, spinach, cabbage, cauliflower, bok choy, brussels sprouts, collard greens and condiments like mustard, mustard greens, horseradish, and wasabi. On the treatment day, a venous cannula will be inserted, and a baseline (fasting) blood sample will be collected. A baseline urine sample will also be collected. Participants will be asked to consume a glucoraphanin-containing vegetable soup at one treatment visit and a non-glucoraphanin-containing vegetable soup at the other treatment visit in a randomly assigned order. Participants will be requested to consume the soup within 10 minutes.
Postprandial blood following soup consumption will be sampled at regular intervals of 30, 60, 120, 180, 240, 360, and 480 min using the cannula for blood collection and then at two interim visits (24h and preferably at 48h). All Interim visits will involve blood collection using a butterfly needle for venipuncture. Urine samples will be collected across 48h, with a time frame of 0, 0-2, 2-4, 4-6, 6-8h, 8-24h and preferably 24-48h after consumption of the soup. A standard breakfast at 60 min (to be consumed in 10 minutes) and lunch at 180 min (to be consumed in 20 minutes) will be provided during each treatment visit.
Intervention code [1] 326301 0
Prevention
Comparator / control treatment
Treatment B- commercially available vegetable soup without glucoraphanin (1 Serving) matched for energy and macronutrient composition.
Control group
Active

Outcomes
Primary outcome [1] 335059 0
To examine changes in the composition and abundance of antioxidant proteins in the circulatory extracellular vesicle as a composite primary outcome- an exploratory outcome.

Plasma samples will be analyzed to characterise blood extracellular vesicles by ultracentrifugation, size exclusion chromatography, NTA NS300, transmission electron microscopy, BCA protein assay and western blot. ELISA/LC-MS will analyse the EVs' protein composition.
(randomized cross-over design)
Timepoint [1] 335059 0
On 6 different occasions:
Treatment Visits (Randomly assigned) 2 & 5; at baseline and 30, 45, 60, 90, 120, 180, 240, 360 and 480 min
Interim Visits 3,4, 6 and 7: 24 hr and 48 hr respectively
Secondary outcome [1] 422886 0
Changes in the plasma metabolites of sulforaphane metabolism- exploratory outcome

Plasma metabolites will be analyzed using LC-MS (randomized cross-over design)
Timepoint [1] 422886 0
On 6 different occasions:
Treatment Visits (Randomly assigned) 2 & 5; at baseline and 30, 45, 60, 90, 120, 180, 240, 360 and 480 min
Interim Visits 3,4, 6 and 7: 24 hr and 48 hr respectively
Secondary outcome [2] 422887 0
Change in the abundance of miRNAs in extracellular vesicles-exploratory outcome
Timepoint [2] 422887 0
At baseline and 30, 45, 60, 90, 120, 180, 240, 360 and 480 min and 24 hr and 48 hr respectively.
Secondary outcome [3] 423056 0
Changes in the Urine metabolites of sulforaphane metabolism- exploratory outcome
Urine samples will be analyzed using LC-MS. Participants will be provided with a urine collection bottle to carry home for 24hr and then for a 24-48-hour visit after consumption of the soup.
Timepoint [3] 423056 0
At baseline and 0-2, 2-4, 4-6, 6-8hr, 8-24hr and 24-48h, respectively.
(randomized cross-over design)

Eligibility
Key inclusion criteria
•Ethnicity: All
•Gender: Males and females
•Age: >55yr
•BMI:18.5-30 kg/m2
•Non-smokers
•Able and willing to attend all site visits
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Current illness or condition which in the view of the investigator and/or advising clinician at the Liggins Institute would affect the compliance or safety of the individual taking part.
• Gastrointestinal disorder that alters nutrient digestion and absorption (e.g., ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy).
• Current use of medications which may interfere with normal digestive processes including proton pump inhibitors, laxatives, and antacids.
• Have used antibiotics within the previous one month or are currently on long-term antibiotics.

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 sequence will be set up through a web-based secure database. Sequences will not be accessible to the research team prior to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized to receive the interventions or the control as the first in a crossover sequence using computer-generated sequences.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Differences in the primary outcome will be compared between treatment groups using repeated measures ANOVA or non-parametric tests where appropriate and followed-up with post-hoc tests. The relationship between secondary outcomes will be assessed using multiple regression analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2023
Actual
Date of last participant enrolment
Anticipated
14/08/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 25588 0
New Zealand
State/province [1] 25588 0
Auckland

Funding & Sponsors
Funding source category [1] 314061 0
University
Name [1] 314061 0
University of Auckland
Country [1] 314061 0
New Zealand
Primary sponsor type
University
Name
Liggins Institute, The University of Auckland
Address
85 Park Road, Grafton, 1023, Auckland
Country
New Zealand
Secondary sponsor category [1] 316012 0
None
Name [1] 316012 0
Address [1] 316012 0
Country [1] 316012 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313197 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 313197 0
Ethics committee country [1] 313197 0
New Zealand
Date submitted for ethics approval [1] 313197 0
22/05/2023
Approval date [1] 313197 0
Ethics approval number [1] 313197 0

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

Contacts
Principal investigator
Name 127314 0
Dr Farha Ramzan
Address 127314 0
Liggins Institute University of Auckland 85 Park Road Grafton Auckland 1023
Country 127314 0
New Zealand
Phone 127314 0
+6499231852
Fax 127314 0
Email 127314 0
[email protected]
Contact person for public queries
Name 127315 0
Farha Ramzan
Address 127315 0
Liggins Institute University of Auckland 85 Park Road Grafton Auckland 1023
Country 127315 0
New Zealand
Phone 127315 0
+6499231852
Fax 127315 0
Email 127315 0
[email protected]
Contact person for scientific queries
Name 127316 0
Farha Ramzan
Address 127316 0
Liggins Institute University of Auckland 85 Park Road Grafton Auckland 1023
Country 127316 0
New Zealand
Phone 127316 0
+6499231852
Fax 127316 0
Email 127316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the Individual participant data (including data dictionaries) collected during the trial will be available after de-identification, along with the study protocol.
When will data be available (start and end dates)?
Data will be available beginning 3 months following the first publication of study results and ending 36 months following publication.
Available to whom?
Data will be available to investigators who provide a methodologically sound proposal approved by the Study Steering Committee, for use to achieve the aims in the approved proposal. Proposals should be directed to the principal investigator. To gain access, requests will need to sign a data access agreement.
Available for what types of analyses?
For use to achieve the aims in an approved proposal.
How or where can data be obtained?
Proposals should be directed to the principal investigator ([email protected]). To gain access, requests will need to sign a data access agreement.


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.