Randomized, double-blind, placebo-controlled, clinical study on the effect of Diabetinol® on glycemic control of subjects with impaired fasting glucose

Abstract

BackgroundThis study investigated the efficacy of Diabetinol® in people with diabetes on medication but not meeting the American Association of Clinical Endocrinologists and American Diabetes Association glycemic, blood pressure, and lipid targets.Subjects and methodsFifty subjects, aged 18–75 years, with fasting blood glucose ≤15.4 mmol/L, hemoglobin A1c levels ≤12%, and a body mass index between 25 and 40 kg/m2, were enrolled in a 24-week, randomized, double-blind, placebo-controlled, parallel study. Diabetinol® or placebo was administered as 2×525 mg capsules/day.ResultsIn the Diabetinol® group, 14.3% versus 0% in the placebo group, 33.3% versus 15.4% in placebo, 20.0% versus 12.5% in placebo, and 83.3% versus 60% in placebo achieved the American Association of Clinical Endocrinologists and American Diabetes Association targets for hemoglobin A1c, low-density lipoprotein, total cholesterol, and systolic blood pressure, respectively. There was no difference in the maximum concentration (Cmax) of serum glucose or area under the curve (AUC)0–240 minutes. The time to Cmax was longer for participants on Diabetinol® than placebo group at week 12 (P=0.01). Fasting blood glucose increased from baseline to week 24 in both groups; however, this increase was 14.3 mg/dL lower in the Diabetinol® group versus placebo. The Diabetinol® group showed an increase of 5.53 mg/dL in fasting insulin at week 12 (P=0.09) and 3.2 mg/dL at week 24 (P=0.41) over and above the placebo group. A decrease of 1.5% in total cholesterol, 5.8% in low-density lipoprotein, and a 1.6% increase in high-density lipoprotein concentrations were seen in the Diabetinol® group. Diabetinol® improved 6-month oral glucose tolerance test and 2-hour postprandial glucose profiles in participants between 40 and 60 years of age.ConclusionThe current study suggests a role for Diabetinol® as an adjunctive therapy for glycemic maintenance and for decreasing the risk of diabetes-associated comorbidities in type 2 diabetic patients on conventional therapies.

Citrus polymethoxyflavones attenuate metabolic syndrome by regulating gut microbiome and amino acid metabolism

“…Hence, there remains an urgent need for the development of effective and safe therapeutic agents. Citrus PMFs are attractive candidates due to their potent protective effects against MetS as well as safety in rodent experimental models ( 17 , 18 ). Here, we used an optimized and standardized method to purify PMFs from citrus peels based on macroporous resin chromatography.…”

Nobiletin exerts anti-diabetic and anti-inflammatory effects in anin vitrohuman model andin vivomurine model of gestational diabetes

“…Given this promising data, there is room for the possible use of the nobiletin as a supplementation therapy for GDM in humans. Already, in non-pregnant humans, clinical trials have found that supplementation of either citrus flavonoids or Diabetinol ® (of which nobiletin is the primary active ingredient) has been found to significantly improve cardiometabolic parameters, including fasting glucose and lipid profiles [78,79]. In contrast, there remains a lack of clinical information on the effect of nobiletin supplementation on pregnancy and long-term offspring outcome.…”

Effectiveness and Safety of a Mixture of Nobiletin and Tangeretin in Nocturia Patients: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study

“…NoT are flavonoids, a kind of polyphenol obtained from the rind of Citrus depressa, which is a type of lemon native to Okinawa in Japan, Taiwan, and China. For example, NoT has been reported to be effective for metabolic disorders [11] or memory impairment [12] as a dietary supplement, although it is not approved for medical use in clinics. From the perspective of chronobiology, a randomized clinical trial was conducted to evaluate the effectiveness and safety of NoT in patients with nocturia (NoT-nocturia study).…”