Phase I Trial Assessing the Safety of Carb Starver

Phase I Trial Assessing the Safety of a metabolic metaboliser, Carb Starver in healthy volunteers.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001561178

Acronym

SOCS

Enrollment

Registered

2019-11-12

Start date

2019-11-14

Completion date

2019-12-04

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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

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

Outcome results