title: Safety and efficacy of the nonsystemic chewable complex carbohydrate dietary supplement PAZ320 on postprandial glycemia when added to oral agents or insulin in patients with type 2 diabetes mellitus.
abstract: OBJECTIVE
  Our primary objective was to evaluate the effect of the dietary supplement PAZ320 on postprandial glucose excursion. PAZ320 is derived from glucomannan and acts by blocking carbohydrate hydrolyzing enzymes and by binding to ingested polysaccharides. Endpoints included area under the curve during postprandial glucose excursion (gAUC) and adverse reactions.
  
  
  METHODS
  In an open-label, sequential dose-escalation, prospective study, we examined the efficacy and safety of PAZ320 in 24 subjects with type 2 diabetes treated with oral agents and/or insulin. Subjects consumed 75 g jasmine rice alone or with low-dose (8 g) or high-dose (16 g) PAZ320. A real-time blinded continuous glucose monitor (CGM) was used to assess 3-hour postprandial glycemia.
  
  
  RESULTS
  We found that 45% of subjects responded to high-dose PAZ320 as evidenced by a decrease in gAUC of 40% compared to baseline in a dose-dependent manner. The effect of PAZ320 does not correlate with duration of diabetes and seems to work regardless of concurrent diabetes medications. The responders had higher postmeal glucose elevation at baseline, while the nonresponders showed no effect or paradoxic glucose response to PAZ320. There was no severe hypoglycemia, and the gastrointestinal side effects were mild.
  
  
  CONCLUSIONS
  PAZ320 may be useful as an adjunct to decrease postprandial glycemia in type 2 diabetes, although patients should verify its effect on postprandial glucose due to a possible paradoxic response. Its safety profile is reassuring. Further study is required to determine its long-term effects on glycated hemoglobin (HbA1c) and to further define which subpopulation may respond to PAZ320.
authors: Dartmouth-Hitchcock Medical Center, Endocrinology Section, Department of Medicine, Lebanon, NH, USA.
authors: Laura E
authors: LE
authors: Trask
authors: Natasha
authors: N
authors: Kasid
authors: Karen
authors: K
authors: Homa
authors: Sushela
authors: S
authors: Chaidarun
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism*; D019587:Dietary Supplements; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008351:Mannans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D019518:Postprandial Period / Q000187:drug effects
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008351:Mannans; C000598421:PAZ320