The effect of nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') on blood glucose levels in prediabetes and type 2 diabetes- A pilot study - Trial ANZCTR12617000361303

Timeline & Enrollment

Primary Outcome

Change in blood glucose levels: This can be measured using glucometers and HbA1c measuring devices.

Summary

This study will investigate the potential of commercially available nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') is similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas. The gliptins block the action of DPP-4, an enzyme which inhibits a group of gastrointestinal hormones called incretins which stimulate the production of insulin post meal and reduce the production of glucagon by the liver during digestion. DPP-4 inhibitors help regulate blood glucose levels by inhibiting incretins reducing the financial burden for antidiabetic medicine equivalent to AU$193.8 million per year. This study aim:- To determine the effect of nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor on glycemic control in patients with type 2 diabetes mellitus. The study will include a total of 80 T2D participants recruited from the community. After an overnight fast (12-hr), participants will attend the clinical areas of the Medical Science Precinct, and the School of Health Sciences, University of Tasmania (UTAS) to undergo the following: 1) Medical & lifestyle questionnaires 2) Anthropometrics 3) Blood tests to measure blood glucose, HbA1c, serum lipids, insulin, & oxidative markers. 4) Glucose metabolism (2hr oral glucose tolerance test). 5) Hemodynamic measures (blood pressure, heart rate & ECG). 6) Urinary electrolytes & kidney function. 7) Pregnancy test for woman during their reproductive life. Venous blood & urine samples will be collected at the start and end of the two phases of the study. Nutraceutical supplements will be provided to the participants for 12 weeks. These natural products possess anti-diabetic activities & the suggested course of supplements will maintain a constant level of dosage of these nutraceutical supplements to improve the overall metabolic functions in T2D cohort. Biomarkers of metabolic response included in this study include measuring 8-hydroxy deoxyguanosine (8-OHdG) (oxidative DNA damage), total lipid peroxidation (lipid peroxidation) & resistin (adipocytokine response).

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