Using a variety of in vivo and in vitro techniques, researchers from Wyeth Nutrition, Wyeth Research, The University of Reading, and the University of Illinois report that consumption of oligofructose at a dietary level of 9.9 per cent did not produce any adverse effects.
The results are published in the Food and Chemical Toxicology, and used Beneo-Orafti’s Orafti P95 (formerly Raftilose 95) derived from chicory root inulin by enzymatic hydrolysis.
The clean safety bill of the ingredient is important, as Beneo’s ingredients have been added to about 80 products in the past year to bring the total to 330 worldwide.
“Despite the extensive use of prebiotic-supplemented formulas in Japan and their recent addition to formulas in Europe, few safety studies have been published,” explained lead author Frances Boyle.
“Since limited preclinical safety data are available, we evaluated the safety and efficacy of OF in rats fed diets containing up to 9.9 per cent oligofructose for 13 weeks.”
Study details
The researchers used both a 13-week rat feeding study and in vitro mutagenicity tests to determine the safety of oligofructose.
Rats were assigned to consume either a control diet, or the control diet supplemented with different doses of oligofructose doses, ranging from 0.55 to 9.91 per cent of the diet.
Boyle and co-workers report significant reductions in total, HDL, and LDL-cholesterol levels in the groups supplemented with oligofructose, compared to controls. The largest effects were observed in male animals receiving the highest oligofructose dose.
Reductions in weight gain were also observed in the male rats receiving the highest dose during the 13 weeks, but there were no significant differences in body weights at the end of study, said the researchers.
Levels of bifidobacteria in the faeces of the animals increased as a result of prebiotic supplementation.
In vitro cells studies showed no pathologic or histopathologic differences between the groups.
“The oligofructose evaluated in this study demonstrated an excellent safety profile, both in a 13-week in vivo study and in a variety of in vitro analyses,” wrote the researchers.
“Based on these data, the no adverse effect observed level (NOAEL) of oligofructose in the diet is 9.91 per cent.
“Although oligosaccharides such as OF are not found in human milk, there may be functional benefits of addition to infant formula or products for use in early childhood,” they concluded.
Source: Food and Chemical ToxicologyVolume 46, Issue 9, Pages 3132-3139“Safety evaluation of oligofructose: 13 Week rat study and in vitro mutagenicity”Authors: F.G. Boyle, J.M. Wrenn, B.B. Marsh, W.I. Anderson, F.A. Angelosanto, A.L. McCartney, E.L. Lien