Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001561178
Ethics application status
Approved
Date submitted
25/09/2019
Date registered
12/11/2019
Date last updated
12/11/2019
Date data sharing statement initially provided
12/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I Trial Assessing the Safety of Carb Starver
Scientific title
Phase I Trial Assessing the Safety of a metabolic metaboliser, Carb Starver in healthy volunteers.
Secondary ID [1] 298968 0
None
Universal Trial Number (UTN)
Trial acronym
SOCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ketosis 313956 0
Condition category
Condition code
Diet and Nutrition 312361 312361 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Weeks
Description of intervention(s) / exposure
Carb starver consists of: D,B-hydroxybutryate, 1,3-butanediol, Sodium, Potassium and Bicarbonates

Dose: 15mg per kilo of body weight
Regimen: 2 times a day over an 8 hour period on one day.
Route: Oral
Adherence: Each dose will be given to the person with the research assistant present at the trial site. A case report form for the day trial will record when the dose was taken, the amount taken, any reactions and any direct observations from the research assistant.
Intervention code [1] 315236 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320988 0
Blood ketone levels will be assessed by laboratory and monitor assay of serum samples.
Timepoint [1] 320988 0
The times points will be baseline (0), 1, 2, 6, 8 and 48 hours.
Secondary outcome [1] 373638 0
Safety will be monitored by blood pathology tests on liver function (GGT, ALT, ALP, LH) and kidney (creatinine, eGFR).
Timepoint [1] 373638 0
The times points will be baseline (0), 1, 2, 6, 8 and 48 hours.
Secondary outcome [2] 376370 0
Adverse events as per the study specific questionnaire in the case report form. e.g. Nausea, fatigue, diarrhoea, stomach discomfort and reduced appetite.
Timepoint [2] 376370 0
1 day and 7th day
Secondary outcome [3] 376585 0
Blood glucose levels will be assessed by laboratory and monitor assay of serum samples.
Timepoint [3] 376585 0
The times points will be baseline (0), 1, 2, 6, 8 and 48 hours.

Eligibility
Key inclusion criteria
1. Generally healthy, no current major disease e.g. cardiovascular failure, undergoing treatment for cancer, acute auto-immune disease
2. Aged 18 years or older
3. Must be able to speak and understand English sufficiently to comprehend the purpose and risks of this study and to provide consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosis of type 1 Diabetes mellitus or are insulin dependent
2. Taking sodium-glucose cotransporter-2 inhibitor (SGCT-2) medication
3. Attempting to conceive, is currently pregnant or breastfeeding
4. History of cardiac failure, renal impairment or hepatic cirrhosis
5. An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, sibling or child whether biological, step or legally adopted.
6. Any clinically significant abnormalities on clinical chemistry, heamatology, urinalysis, physical examination, medical history or vital signs (permission from general practitioner is required)
7. History of significant hypersensitivity to drugs

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Basic descriptive statistics will be incorporated with the low numbers. Paired T-tests will be completed and safety data examined for side effects and changes in liver and renal pathology. Safety will also be examined for glucose and ketone levels and qualitative analyses will be conducted for end of study evaluation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/11/2019
Actual
Date of last participant enrolment
Anticipated
4/12/2019
Actual
Date of last data collection
Anticipated
11/12/2019
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 28356 0
4103 - Annerley
Recruitment postcode(s) [2] 28357 0
4006 - Fortitude Valley
Recruitment postcode(s) [3] 28358 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 303509 0
Commercial sector/Industry
Name [1] 303509 0
Carb Starver Pty Ltd
Country [1] 303509 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Carb Starver Pty Ltd
Address
Level 16, 239 George St,
Brisbane, Queensland, Australia 4000
Country
Australia
Secondary sponsor category [1] 303563 0
None
Name [1] 303563 0
None
Address [1] 303563 0
None
Country [1] 303563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304034 0
Endeavour College of Natural Health Human Research Ethics Committee
Ethics committee address [1] 304034 0
269 Wickham St, Fortitude Valley, 4006 QLD
Ethics committee country [1] 304034 0
Australia
Date submitted for ethics approval [1] 304034 0
07/08/2019
Approval date [1] 304034 0
15/08/2019
Ethics approval number [1] 304034 0
20190815-JS-1

Summary
Brief summary
This is a safety trial looking at a powder that produces ketones in the body. Ketones are naturally occurring modules that are produced when someone is fasting or haven't eaten for 6 hours or longer. The body can use them as an energy source when blood glucose is low. This project will be recruiting 10 healthy individuals and will test 2 doses of the powder given to them on one day. This will be compared to their blood glucose, ketone level and blood safety markers 2 days later to see if there are any changes. The aim of the project is ensure the safety of the product in humans so it can be used in clinical trials.
Trial website
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 95610 0
Dr Janet Schloss
Address 95610 0
Endeavour College Of Natural Health,
Office of research
Level 2, 269 Wickham Street,
Brisbane, Queensland, Australia 4006
Country 95610 0
Australia
Phone 95610 0
+61 7 3253 9579
Fax 95610 0
Email 95610 0
[email protected]
Contact person for public queries
Name 95611 0
Dr Janet Schloss
Address 95611 0
Endeavour College Of Natural Health,
Office of Research
Level 2, 269 Wickham Street,
Brisbane, Queensland, Australia 4006
Country 95611 0
Australia
Phone 95611 0
+61 7 3253 9579
Fax 95611 0
Email 95611 0
[email protected]
Contact person for scientific queries
Name 95612 0
Dr Janet Schloss
Address 95612 0
Endeavour College Of Natural Health,
Office of Research
Level 2, 269 Wickham Street,
Brisbane, Queensland, Australia 4006
Country 95612 0
Australia
Phone 95612 0
+61 7 3253 9579
Fax 95612 0
Email 95612 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small safety trial, ten participants only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3870Ethical approval  [email protected] 378138-(Uploaded-16-10-2019-14-58-58)-Study-related document.pdf



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.