Salba-chia(Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double- blind randomized controlled trial

Background and Aim: Preliminary findings indicate that consumption of Salba-chia (Salvia hispanica L.), an ancient seed, improves management of type 2 diabetes and suppresses appetite. The aim of this study was to assesse the effect of Salba-chia on body weight, visceral obesity and obesity-related risk factors in overweight and obese adults with type 2 diabetes. Methods: A double-blind, randomized, controlled trial with two parallel groups involved 77 overweight or obese patients with type 2 diabetes (HbA1c: 6.5e8.0%; BMI: 25e40 kg/ m2). Both groups followed a 6-monthcalorie-restricted diet; one group received 30 g/ 1000 kcal/ day of Salba-chia, the other 36 g/ 1000 kcal/ day of an oat bran-based control. Primaryendpointwas change in bodyweight over 6-months. Secondary endpoints included changes inwaist circumference, body composition, glycemic control, C-reactive protein, and obesity-related satiety hormones. Results: At 6-months, participants on Salba-chia had lost more weight than those on control (1.9 +/- 0.5 kg and 0.3 +/- 0.4 kg, respectively; PZ0.020), accompanied by a greater reduction inwaist circumference (3.5 +/- 0.7 cm and 1.1 +/- 0.7 cm, respectively; P Z 0.027). C-reactive protein was reduced by 1.1 +/- 0.5 mg/ L (39 +/- 17%) on Salba-chia, compared to 0.2 +/- 0.4 mg/ L (7 +/- 20%) on control (P Z0.045). Plasma adiponectin on the test intervention increased by 6.5 +/- 0.7%, with no change observed on control (PZ0.022). Conclusions: The results of this study, support the beneficial role of Salba-chia seeds in promoting weight loss and improvements of obesity related risk factors, while maintaining good glycemic control. Supplementation of Salba-chia may be a useful dietary addition to conventional therapy in the management of obesity in diabetes. Registration: clinicaltrials. gov identifier: NCT01403571. (C) 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B. V. All rights reserved.