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

INTERVENTION: This study will investigate the potential of commercially available nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') 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. This study has one intervention: Intervention 1 (week zero to week 12): To use nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP‐4 inhibitor in patients with type 2 diabetes mellitus. Thompson’s Super Bioflavonoid Complex 'Registered Trademark': Active Compounds: Citrus bioflavonoid extract, ascorbic acid, rutin, sodium ascorbate. Composition: Citrus Bioflavonoid Extract‐500 mg; Ascorbic Acid‐ 390 mg; Rutin‐ 100 mg; Sodium ascorbate‐ 125.3 mg. Number of Tablets in each pack: 120 Mode of Administration: Two tablets per day before/with meal (NOT AFTER MEAL) Strategies used to monitor adherence to the intervention: Participants will be asked to complete a logbook to record the day and time they take the tablets. CONDITION: Type 2 Diabetes mellitus PRIMARY OUTCOME: Change in blood glucose levels: This can be measured using glucometers and HbA1c measuring devices. SECONDARY OUTCOME: Change in levels of oxidative stress: Oxidative stress can be chemically measured using 8‐Hydroxy deoxyguanosine ELISA kit and Human resistin ELISA kit. Change in the levels of Dipeptidyl Peptidase 4 (DPP‐4) enzyme activity: Using DPP‐4 ELISA kit. Changes in the levels of serum lipids: Serum lipids can be measured chemically using ELISA kits. INCLUSION CRITERIA: For all participants 1. Have been clinically diagnosed with type 2 diabetes. 2. Aged between (25 and 75) years. 3. Lean, overweight or obese (BMI 19 to 35 kg/m2). 4. Have normal or controlled blood pressure. 5. Normotensive (seated brachial blood pressure less than 140/90 mmHg). 6. Have given signed informed consent to participate in the study. 7. Clinically diagnosed T2D on diet and lifestyle intervention or metformin only treatment (e.g. fasting plasma glucose equal or more than 7.0mM, HbA1c). 8. Willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks. 9. Negative pregnancy test for the woman during their reproductive life.