Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001347550
Ethics application status
Approved
Date submitted
12/10/2024
Date registered
7/11/2024
Date last updated
24/11/2024
Date data sharing statement initially provided
7/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of interstitial fluid (ISF) Collection Methods and Metabolite Profiles in Healthy Humans.
Scientific title
Evaluation of interstitial fluid (ISF) Collection Methods and Metabolite Profiles in Healthy Humans for Relative Quantification of Endogenous Metabolites
Secondary ID [1] 313174 0
NCRC-AU-2024/004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolomics for biomarker profiles 335457 0
Condition category
Condition code
Metabolic and Endocrine 332017 332017 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective study with enrolment of normal healthy participants in the community, unlinked
and de-identified. This study will be multi-stage (Stage 1 to 3) with interim analyses following completion of each stage.

Interim analyses between stages will determine if any optimizations or design changes for the Nutromics ISF Collector are required in order to better achieve the primary objective. Additionally, the metabolite profiles between ISF and plasma matrices will be analyzed and reviewed. Based on these analyses, we will modify the protocol as needed to improve the identification of common metabolites across matrices.

Each stage will have no more than 10 participants. Recruitment for Stage 2 and 3 will not commence until the preceding stage interim analysis are completed. Participants may participate in more than one stage of the Study, subject to their continued eligibility. This registration covers Stages 1-3

: Potential participants will be recruited by advertising using flyers posted on community, university, and
Nutromics Operations noticeboards. The flyer will also be digitally posted on Social Media. Interested participants will express interest via email to clinical.researchcentre@nutromics.com after which they will be sent an Online Health Screening. Nutromics employees are able to participate in this study.

Participants who meet the inclusion criteria (as per the Online Health Screening Survey) will be contacted for a brief phone screening for inclusion/exclusion criteria, including an explanation of the study details. A copy of the patient information sheet and consent form will be given to the participants who meet the inclusion criteria and still express interest in participating in the study following the phone discussion. Eligible participants who agree to participate in the study will be given time to consider their decision. Eligible participants who agree to participate in the study will be asked to attend an on-site Visit, where written consent will be obtained before any study procedures are conducted.

The Nutromics ISF Collector is applied to the participants by a study team member and is stuck to the skin by a standard medical adhesive liner. Hollow microneedles insert into the skin~ 3mm. Participants at the onsite visit with remain in the Nutromics Clinical Research Centre and be observed by a study team member for the duration of the study.

On Site Visit; to be performed by the Principal Investigator or Clinical Research Coordinator (for Stages 1-3)
1. On Site Visit (~ 3 hours)
1. Written informed consent will be obtained
2. Blood is collected for Pregnancy test in all participants with childbearing potential, The pregnancy test must be processed before proceeding to Step #3 to confirm eligibility.
o Participants who are not of childbearing potential skip to Step #3.
3. Pathology test bloods (FBC, UEC, LFT and CRP) and bloods for metabolite analyses are collected prior to application of first set of Collectors.
4. Two Collectors are applied to the same upper arm of the participant for 10 minutes (ie; first set of Collectors), after which they are removed and handled in accordance with the Instructions For Use.
o Participants will complete a Pain Assessment following the application and removal of the first set of Collectors to assess the pain associated with their application.
o Images of the application site prior to the application of the first set of Collectors, and after their removal will be taken.
5. Two hours following the first set of Collectors are applied, another two Collectors (ie; the second set are collectors) are applied to the same upper arm applied the first set of Collectors in Step #5 of the participant for 10 minutes, after which they are removed and handled in accordance with the Instructions For Use
o Participants will complete a Pain Assessment following the application and removal of the second set of Collectors to assess the pain associated with their application.
o Images of the application site prior to the application of the second set of Collectors, and after their removal will be taken.
6. Following the removal of the second set of Collectors, pathology test bloods (FBC, UEC, LFT and CRP) and blood for metabolite analyses are collected.
7. Participant is observed for 15 minutes to monitor any adverse events, after which they are discharged from the site.

Follow Up Survey
The participant will be sent a follow-up survey, within the 48 hours following discharge. The survey will require a Pain Assessment and an image of the application sites of the Collectors.
Intervention code [1] 329747 0
Early detection / Screening
Comparator / control treatment
No Control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339620 0
The efficacy of the Collector in collecting ISF.
Timepoint [1] 339620 0
At two time points, 2 hours apart at the On-Site Visit. Each Collector is applied for 10 minutes.
Secondary outcome [1] 440630 0
Identify and relatively quantification of endogenous metabolites in ISF and contemporaneous plasma samples.
Timepoint [1] 440630 0
Samples collected at two time points, 2 hours apart at the On-Site Visit. Each Collector is applied for 10 minutes.
Secondary outcome [2] 440963 0
To evaluate the safety of the Nutromics ISF Collector
Timepoint [2] 440963 0
o Blood tests for Safety Evaluation are collected prior to the application of the first set of Collectors, and following removal of the Second set of Collectors.
o Photos are taken before the application and following the removal of each set of Collectors and a pain survey is conducted following the application and removal of each set of Collectors
o Assess adverse events are assessed at the On-Site Visit, and in the Follow Up Survey which will occur within 48 hours following discharge from the Site.
Secondary outcome [3] 441458 0
Characterize the impact of hydration on the ability of the ISF Collector to obtain interstitial fluid.
Timepoint [3] 441458 0
Serum Osmolality will be collected prior to application of the first set of collectors, and following removal of the second set of collectors. ISF is collected on two occasions, two hours apart.

Eligibility
Key inclusion criteria
• Participants self-declaring healthy without any disease, condition or syndrome or on any current medical treatments
• Aged 18 and above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants are pregnant, planning to become pregnant, breastfeed, or donate ova.
• Participants who declare previous allergic reactions to metals, plastics, and adhesives.
• Participants who have a history of fainting or experiencing vasovagal reactions during blood draws
• Non-English speaking participants

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
28/11/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317617 0
Commercial sector/Industry
Name [1] 317617 0
Nutromics Operations
Country [1] 317617 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nutromics Operations
Address
Country
Australia
Secondary sponsor category [1] 319935 0
None
Name [1] 319935 0
Address [1] 319935 0
Country [1] 319935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316321 0
Nutromics Diagnostics HREC
Ethics committee address [1] 316321 0
Ethics committee country [1] 316321 0
Australia
Date submitted for ethics approval [1] 316321 0
19/10/2024
Approval date [1] 316321 0
29/10/2024
Ethics approval number [1] 316321 0

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

Contacts
Principal investigator
Name 137518 0
Dr Kevin Friedman
Address 137518 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 137518 0
Australia
Phone 137518 0
+17707143679
Fax 137518 0
Email 137518 0
kevin.friedman@nutromics.com
Contact person for public queries
Name 137519 0
Emily Birthisel
Address 137519 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 137519 0
Australia
Phone 137519 0
+61 450695551
Fax 137519 0
Email 137519 0
emily.birthisel@nutromics.com
Contact person for scientific queries
Name 137520 0
Emily Birthisel
Address 137520 0
Nutromics; 420 Victoria Street, Brunswick VIC, Australia
Country 137520 0
Australia
Phone 137520 0
+61 450695551
Fax 137520 0
Email 137520 0
emily.birthisel@nutromics.com

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?

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.