None listed
Conditions
Brief summary
The aim of this study is to assess the efficacy of Trigonella foenum-graecum (Fenugreek) Seed Extract and Coccinia indica in reducing elevated normal blood glucose levels through reducing insulin levels (B-cell function) and reducing insulin resistance (blood glucose) in pre-diabetics. In addition, other parameters associated with altered metabolism that contribute to the development of diabetes, HBa1c, lipid studies, body weight will also be assessed.
Interventions
Arm 1: Trigonella foenum-graecum Seed Extract, 250mg twice per day (500mg/day) for 12 weeks. capsule taken orally.
Arm 2: Coccinia Grandis Extract, 500mg twice per day (1000mg.day) for 12 weeks, capsule taken orally.
Arm 3: Placebo (maltodextrin), 2 capsules per day, for 12 weeks,
Sponsors
Evidence Sciences Pty. Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and females at least 18 years of age at time of entry on study; Impaired Fasting blood glucose levels and/or insulin resistance; BMI is greater than 25; Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment; Agree to undergo venipuncture on multiple occasions; Agree to adhere to the study protocol, including not changing diet or major exercise patterns over the 12 week study period.
Exclusion criteria
Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: - Physical examination; Clinical chemistry; Haematology; Urinalysis; Vital signs; - Diagnosis of Type II Diabetes Mellitus - Taking Anti-Obesity medications such as Orlistat - Taking oral blood glucose-lowering medications such as Sulfonylureas, Biguanides, Alpha-glucosidase inhibitors, Thiazolidinediones - Taking any dietary supplements or herbal medicines specifically for supporting blood sugar including lipoic acid and gymnemia etc. - Have recent episodes of symptomatic coronary arterial disease, stroke, and any cardiovascular events including infarction (heart attack) - Having treatment for cancers within last 5 years; - Taking anti-coagulants such as warfarin; - Having any allergies or past reactions to ingredients in treatment and placebo supplements, including fenugreek seeds, cucumber or maltodextrin; - Alcohol abuse; - The use of any illicit drugs; - (Women only) Pregnancy or nursing of an infant; or not taking adequate precautions to prevent pregnancy; or not having had a normal menstrual cycle. - Commencing lifestyle interventions such as major dietary changes and increasing exercise duration/intensity; .
Outcome results
None listed