The maximum single dose of resistant maltodextrin that does not cause diarrhea in humans.
The objective of the present study was to determine the maximum dose of resistant maltodextrin (Fibersol)-2, a non-viscous water-soluble dietary fiber), that does not induce transitory diarrhea. Ten healthy adult subjects (5 men and 5 women) ingested Fibersol-2 at increasing dose levels of 0.7, 0.8, 0.9, 1.0, and 1.1 g/kg body weight (bw). Each administration was separated from the previous dose by an interval of 1 wk. The highest dose level that did not cause diarrhea in any subject was regarded as the maximum non-effective level for a single dose. The results showed that no subject of either sex experienced diarrhea at dose levels of 0.7, 0.8, 0.9, or 1.0 g/kg bw. At the highest dose level of 1.1 g/kg bw, no female subject experienced diarrhea, whereas 1 male subject developed diarrhea with muddy stools 2 h after ingestion of the test substance. Consequently, the maximum non-effective level for a single dose of the resistant maltodextrin Fibersol-2 is 1.0 g/kg bw for men and >1.1 g/kg bw for women. Gastrointestinal symptoms were gurgling sounds in 4 subjects (7 events) and flatus in 5 subjects (9 events), although no association with dose level was observed. These symptoms were mild and transient and resolved without treatment.
Matsutani Chemical Industry Co., Ltd.
Yuka
Y
Kishimoto
Sumiko
S
Kanahori
Katsuhisa
K
Sakano
Shukuko
S
Ebihara
D000328:Adult; D000368:Aged; D003967:Diarrhea / Q000139:chemically induced* / Q000150:complications; D004043:Dietary Fiber / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D005243:Feces; D005260:Female; D005740:Gases; D006801:Humans; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D012737:Sex Factors; D055815:Young Adult
D004043:Dietary Fiber; D005740:Gases; D011134:Polysaccharides; C008315:maltodextrin