Effects of herbal supplements on postprandial glucose spikes in prediabetic adults: A randomized, double-blind, placebo-controlled, crossover study.

INTERVENTION: Intervention1: LN19183 ‐ 450 mg/dl: One capsule daily, 10‐20 min before breakfast on day 1 to 14 of each period Control Intervention1: Placebo: One capsule daily, 10‐20 min before breakfast on day 1 to 14 of each period CONDITION: PRIMARY OUTCOME: Change from baseline to end of study in ; Post‐prandial glucose response during 120 minutes Incremental area under the curve, iAUC for glucose at fasting and post‐breakfast at 15, 30, 45, 60, 90 and 120 minutes expressed as millimoles per minute per liter.Timepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. SECONDARY OUTCOME: Change from baseline to end of study in ; ; Hunger using visual analog scale, 100 mm VAS ; Timepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; ; Standard deviation, coefficient of variation, and Mean amplitude of glycemic excursions on CGM ; Timepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; Desire to eat using visual analog scale, 100 mm VASTimepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; Fasting Blood Glucose. ; Timepoint: Baseline I, Period 1: Day 14, Baseline II, Period II Day 14. Change from baseline to end of study in ; Fatigue using visual analog scale, 100 mm VASTimepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; Fullness using visual analog scale, 100 mm VAS ; Timepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; Mood using visual analog scale, 100 mm VASTimepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; percentage of time in range on CGM 70 to 120 mg per dL and percentage time above and below target range on CGMTimepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. Change from baseline to end of study in ; Prospective food consumption using visual analog scale, 100 mm VASTimepoint: Baseline I, Period 1: Days 1, 14, Baseline II, Period II Days 1, 14. INCLUSION CRITERIA: Male and female subjects aged 25‐45 years with a Body Mass Inde Xof 22 to 29.9 kg per meter square. 2.Subjects with Fasting Blood Glucose 100‐125 mg per dl. 3.Subject with HbA1c value of 5.7 ‐ 6.4 percent. 4.Subjects agree to use continuous glucose monitoring device as per study protocol. 5.No history of diabetes, metabolic, or cardiovascular disease. 6.Subjects with normal thyroid profile. 7.Willing and able to read and sign informed consent and complete all tests and procedures as listed in the protocol. 8.Subject willing to maintain diet tracker, and agrees to maintain current dietary habits through end of study period. 9.Females of childbearing potential who are sexually active must agree to use adequate non‐hormonal contraception during the study. Female subjects of non childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy