title: Efficacy and tolerance of a diabetes specific formula in patients with type 2 diabetes mellitus: An open label, randomized, crossover study.
abstract: OBJECTIVE
  This study evaluated the effect of a diabetes specific formula on acute glucose, insulin, and triglyceride responses in patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This open-label, randomized, crossover, pilot single center study had two phases (pre-treatment and treatment). After screening, the patients entered run-in period and were counseled on diet and exercise regime. They were then randomly allocated to receive either diabetes specific formula (Nutren Diabetes, Nestlé Health Science, Switzerland; Group A) or isocaloric meal (Cornflakes and milk; Group B). Blood samples were collected to estimate blood glucose, insulin and triglyceride levels (Baseline at 0 min and post-meal at 30, 60, 120, and 180 min).
  
  
  RESULTS
  Area under curve for blood glucose post-meal at 30 min, 60 min, 120 min, and 180 min was significantly lower for Group A as compared with Group B (p=0.003, 0.0001, 0.0001, 0.0001, respectively). Increase in serum insulin levels from baseline was also lower for Group A post-meal at 120 and 180 min, respectively, as compared to Group B (p=0.0001 and 0.0002, respectively).
  
  
  CONCLUSIONS
  The Diabetes specific formula tested in this study showed lower post-meal blood glucose and insulin levels as compared with isocaloric meal. Thus, diabetes specific formula may be an option for diabetic and hyperglycemic patients in need of nutritional support.
authors.affiliation: Diabetes Foundation (India), SDA, New Delhi, India; National Diabetes, Obesity and Cholesterol Foundation (N-DOC), SDA, New Delhi, India; Center of Nutrition & Metabolic Research (C-NET), SDA, New Delhi, India.
authors.forename: Seema
authors.initials: S
authors.lastname: Gulati
authors.affiliation: Diabetes Foundation (India), SDA, New Delhi, India; National Diabetes, Obesity and Cholesterol Foundation (N-DOC), SDA, New Delhi, India; Center of Nutrition & Metabolic Research (C-NET), SDA, New Delhi, India; Fortis C-DOC Center for Excellence for Diabetes, Metabolic Disease and Endocrinology, New Delhi, India; Fortis Flt. Lt. Rajan Dhall Hospital, Vasant Kunj, New Delhi, India. Electronic address: anoopmisra@metabolicresearchindia.com.
authors.forename: Anoop
authors.initials: A
authors.lastname: Misra
authors.affiliation: National Diabetes, Obesity and Cholesterol Foundation (N-DOC), SDA, New Delhi, India; Center of Nutrition & Metabolic Research (C-NET), SDA, New Delhi, India.
authors.forename: Kriti
authors.initials: K
authors.lastname: Nanda
authors.affiliation: All India Institute of Medical Sciences (AIIMS), New Delhi, India.
authors.forename: Ravindra M
authors.initials: RM
authors.lastname: Pandey
authors.affiliation: Nestlé India Limited, Gurgaon, India.
authors.forename: Vivek
authors.initials: V
authors.lastname: Garg
authors.affiliation: Nestlé India Limited, Gurgaon, India.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Ganguly
authors.affiliation: Nestlé Health Science, AOA region, Singapore.
authors.forename: Lorena
authors.initials: L
authors.lastname: Cheung
mesh_terms: D015415:Biomarkers / Q000097:blood*; D001786:Blood Glucose / Q000032:analysis; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000178:diet therapy*; D005260:Female; D005500:Follow-Up Studies; D005526:Food, Formulated; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D012307:Risk Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D014280:Triglycerides
keywords: Diabetes specific formula; Postprandial glucose; Type 2 diabetes mellitus