Safety and tolerability of a novel oral nutritional supplement in healthy volunteers.

Clinical Nutrition : Official Journal of the European Society of Parenteral and Enteral Nutrition
Annalisa BonelliMaurizio Muscaritoli

Abstract

Foods for Special Medical Purposes (FSMPs) are formulated to support the nutritional needs of subjects with impaired capacity to ingest, digest or absorb ordinary food or nutrients. Polglumyt® is a proprietary highly purified, high quality glycogen obtained from mussels. Here we report the results of a single-center, single dose, open label, single arm study carried out to investigate acceptance (i.e. gastrointestinal tolerance and palatability), metabolic profile and safety of a low osmolarity, high-density energy Polglumyt®-based drink (the investigational product, IP) as a novel FSMP. Twelve healthy subjects received a single oral administration of the IP under fasting conditions. The study endpoints were: changes in gastrointestinal system tolerability at 3 h, 6 h and 24 h after IP intake; IP palatability evaluation; metabolic evaluation through the kinetic profile of circulating glucose, insulin and C-peptide from 0 h to 6 h after IP intake and changes from baseline in circulating triglycerides at 3 h and 6 h after IP intake. The IP showed a good gastrointestinal tolerability and an acceptable palatability. The IP did not affect the physiological glycemic profile and the triglycerides levels 6 h after the intake. The IP wa...Continue Reading

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Sep 20, 2016·Clinical Nutrition : Official Journal of the European Society of Parenteral and Enteral Nutrition·T CederholmP Singer
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Aug 2, 2019·Current Gastroenterology Reports·Berkeley N LimketkaiKaren Allen

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