None listed
Conditions
Brief summary
We have demonstrated that an extract from the dahlia plant significantly improved glucose concentrations in diabetic mice and men with pre-diabetes. This study will extend this to test different times of administration, frequency and doses in people with pre-diabetes and type 2 diabetes.
Interventions
The intervention is a Dahlia spp. extract, the subject of previous study described in application ACTRN12617001605381. THis is an oral capsule. This study is a placebo controlled dose-ramping study randomised for dose frequency and time of administration. Participants will be randomised into four equal groups stratified by metformin use and by HbA1c. Each group will then complete a dose-ramping protocol over four weeks as outlined in the protocol. Two groups will receive the extract three times
The intervention is a Dahlia spp. extract, the subject of previous study described in application ACTRN12617001605381. THis is an oral capsule. This study is a placebo controlled dose-ramping study randomised for dose frequency and time of administration. Participants will be randomised into four equal groups stratified by metformin use and by HbA1c. Each group will then complete a dose-ramping protocol over four weeks as outlined in the protocol. Two groups will receive the extract three times per day and two groups twice per day. For both conditions, one group with take it immediately prior to a meal and the other one hour prior to meals. In week one all participants will receive placebo. In week two the extract dose will be 30mg (BD or TDS as above). week three, 60mg and week four 120mg. Adherence will be monitored with capsule return and count using blister packing for each week. Participants will have a subcutaneous continuous glucose monitor for all four weeks of the study.
Sponsors
Aroma NZ
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Males 18 years and over Pre-diabetes or type 2 diabetes with HbA1c between 45 mmol/mol and 60 mmol/mol Willing to maintain a stable lifestyle throughout the study
Exclusion criteria
• Using any diabetes drug other than Metformin • Previous bariatric surgery • Pregnancy or breast feeding • Liver disease or AST/ ALT >3x ULN • Diabetic nephropathy with an eGFR <60. • Stage 3 or 4 NYHF heart failure • Proliferative retinopathy • Allergy to sports tape • Any other long-term condition considered inappropriate by principal investigator.
Outcome results
None listed