Healthy Clinical Trial
Official title:
Double-blind, Randomized, Placebo Controlled Study to Investigate the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
The purpose of this study is to re-confirm the already established health effects and dose tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food ingredient.
Isomalto-oligosaccharide (IMO) is a mixture of natural resistant carbohydrates consisting of
short-chains of glucose molecules. IMO is made by enzymatic conversion of starch and uses as
a health food ingredient with health benefits of a low calorie sweetener, prebiotic and
dietary fiber. IMO have been ingested by humans for last many centuries as it is naturally
found in rice miso, sake and soy sauce. IMO already got approval from FDA (GRAS) and from
Health Canada.
There are number of published studies (in humans and animals) regarding the health benefits
of IMO as an effective prebiotic, and its role in improving overall human gastric health.
Studies also showed that IMO have found to be most tolerable with least adverse effects
compared to other short-chain resistant oligosaccharides. Current clinical studies are
conducted to verify the above given health benefits in BioNeutra's manufactured
VitaSugar/VitaFiber-IMO products which including quantitative analysis of Bifidobacteria
spp., Lactic acid bacteria group and clostridium spp. The production of short-chain
fatty-acids (SCFA) and effect on blood glucose level are also analyzed in addition to the
dose tolerance in term of lower and upper permissible dosage with resultant adverse effects
if any are also observed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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