Supplementation of the diet with the functional fiber PolyGlycoplex is well tolerated by healthy subjects in a clinical trial.
BACKGROUND
The relationship of dietary fiber to overall health is of great importance, as beneficial effects have been demonstrated with the use of fiber from diverse sources, some traditional, other novel. PolyGlycopleX (PGX) is a unique proprietary product composed of three water-soluble polysaccharides, that when processed using novel technology give rise to a final product - a soluble, highly viscous functional fiber.


METHODS
Because of its potential use in food and dietary supplements, a randomized, double-blind, placebo controlled clinical study was conducted to evaluate the tolerance to PGX ingestion for 21 days, to a maximum dose level of 10 g per day, in healthy male and female volunteers. The main objective of the study was to evaluate the overall gastrointestinal (GI) tolerance, while secondary objectives were to evaluate possible changes in hematological, biochemical, urinary and fecal parameters.


RESULTS
Results show that PGX is well tolerated as part of a regular diet with only mild to moderate adverse effects, similar to those seen with a moderate intake of dietary fiber in general, and fruits and vegetables. Because PGX is a highly viscous, functional fiber, it also demonstrates several physiological responses including, but not limited to maintaining healthy total and LDL cholesterol and uric acid levels.
Carabin
Ioana G
IG
Burdock Group, Orlando, Florida, USA. icarabin@burdockgroup.com
Lyon
Michael R
MR
Wood
Simon
S
Pelletier
Xavier
X
Donazzolo
Yves
Y
Burdock
George A
GA
D000293:Adolescent; D000328:Adult; D000464:Alginates / Q000008:administration & dosage* / Q000009:adverse effects; D004043:Dietary Fiber / Q000008:administration & dosage* / Q000009:adverse effects; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage* / Q000009:adverse effects
D000464:Alginates; D004043:Dietary Fiber; D004338:Drug Combinations; C540519:PolyGlycoplex; D011135:Polysaccharides, Bacterial