The effect of the Nutrition-Care Gluco-Metabolism Formula on glucose levels in pre-diabetic adults: The Gluco-Metabolism Trial

INTERVENTION: Randomised double‐blind placebo‐controlled trial of 12 weeks duration investigating the effect and tolerability of the Nutrition‐Care Gluco‐Metabolism‐Herbal Formula on glucose levels in pre‐diabetic adults. The intervention will comprise of 2x3 Gluco‐Metabolism tablets (active group) or placebo (control group) daily for 12 weeks. The active tablets contain a gymnema silvestre, cinnamon cassia, bitter melon, fenugreek, nigella sativa, portulaca oleracea, alpha‐lipoic acid, chromium picolinate, and biotin. Daily dosage is 25g/ day. Compliance will be assessed by returned tablet count at 4‐weekly visits. CONDITION: Metabolic and Endocrine ‐ Diabetes Pre‐diabetes; ; Pre‐diabetes PRIMARY OUTCOME: Ambulatory glucose profile (incl mean glucose levels) by continuous glucose monitoring using a permanently fitted Glucose Sensor (Abbott Freestyle Libre)[Twice continuously over a 2 week period: At enrolment (weeks 1+2) and at end of the study (weeks 11+12) ] Fasting plasma glucose measured by fingerprick test and blood Glucose Meter[4,8,12 weeks of intervention compared to baseline] Post‐prandial plasma glucose measured by fingerprick test and blood Glucose Meter[12 weeks compared to baseline] SECONDARY OUTCOME: fasting insulin by blood test[0 and 12 weeks] HbA1c by microspot blood test[0 and 12 weeks] Visceral fat by body impedance analysis (BIA)[0 and 12 weeks] Zonulin stool spot test [0 and 12 weeks] INCLUSION CRITERIA: 1) Pre‐diabetes: FPG: 5.5‐7.0 mmol/l and/or PPG: 7.8‐11.1 mmol/l Assessment done with Accu‐Chek Mobile Blood Glucose Meter (Roche) & disposable strips