Placebo controlled, double-blind study for efficacy of two herbal supplements (Trigonella foenum-graecum Seed Extract and Coccinia Grandis Extract) for Normalizing Elevated (pre-diabetic) blood Glucose and improving Insulin Sensitivity - a 3 arm study.
- Conditions
- pre-diabetesdiabetesMetabolic and Endocrine - DiabetesAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12618000031268
- Lead Sponsor
- Evidence Sciences Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 79
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.
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;
.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting and 2 hr blood glucose in oral glucose tolerance test, OGTT.<br>[Baseline, Week 6 and week 12 (which is the primary outcome)];Fasting and 2hr insulin in oral glucose tolerance test, OGTT.[Baseline, Week 6, Week 12 (which is primary outcome)]
- Secondary Outcome Measures
Name Time Method Glycosylated haemoglobin (HbA1c)[Baseline, week 6 and week 12];Lipid Studies on blood test[Baseline and week 12];Electrolyte / Liver Function blood test (composite blood test) <br>[Baseline, Week 12];Body weight[Baseline, week 12];Safety outcomes :<br>Full Blood Count (RBC)<br><br>[Baseline, Week 12];Reported adverse reactions - e.g irritation to nasal passages on application, or any gastrointestinal reactions.[Adverse reactions are monitored throughout the study be regular followup calls and scheduled clinic visits as well as assessment of the pathology results.]