Phase I Trial Assessing the Safety of Carb Starver

Not Applicable

• Conditions: Ketosis; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12619001561178
• Lead Sponsor: Carb Starver Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-12
• Last Update Posted: 18 November 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Observational
• Study Design: Not specified