Fibermalt is well tolerated in healthy men and women at intakes up to 60 g/d: a randomized, double-blind, crossover trial

Abstract

In this randomized, double-blind crossover trial, the digestive tolerance of a novel dietary fibre (fibermalt, an indigestible maltose alternan oligosaccharide) was assessed in healthy men and women. Twenty-nine subjects consumed 0 (control), 45 or 60 g of fibre in two doses per day for 2-week treatment periods, each separated by a 2-week washout. Results indicated no differences between treatments in composite gastrointestinal (GI) symptom scores (sum of six GI symptom ratings), individual GI symptoms (nausea, bloating, GI rumbling, gas/flatulence, abdominal pain, diarrhoea), bowel characteristics (frequency, faecal consistency, faecal hardness, straining, discomfort and incomplete evacuation) or average daily faecal output. The symptom scores were consistently low for each treatment period with means averaging below 1 out of a possible range of 0-12 for the composite score. The results of this study suggest that fibermalt is well tolerated at intakes up to 60 g of fibre per day.

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults

“…The BTQ used in this study was similar to that used in previous tolerability studies [ 38 , 39 ]. Ten tolerability issues were included in the BTQ: gas/flatulence, nausea, vomiting, abdominal cramping, stomach rumbling, burping, reflux (heartburn), diarrhea, headache, and dizziness.…”

Type-4 Resistant Starch in Substitution for Available Carbohydrate Reduces Postprandial Glycemic Response and Hunger in Acute, Randomized, Double-Blind, Controlled Study

“…A GI Tolerability Questionnaire [ 21 ] was administered at visits 2 and 3 (days 0 and 7) to assess the presence and severity of selected GI symptoms including nausea, GI rumblings, abdominal pain, bloating, flatulence, and diarrhea during the 0–180 min time period, where t = 0 min was the start of study product consumption. GI symptoms were scored as follows: 0 = none, 1 = no more than usual, 2 = somewhat more than usual, and 3 = much more than usual.…”

Precision Microbiome Modulation with Discrete Dietary Fiber Structures Directs Short-Chain Fatty Acid Production

“…The severity of each symptom was reported on a 3-points scale, with '0' denoting 'no symptoms/no more than usual', '1' denoting 'somewhat more than usual', and '2' denoting 'much more than usual'. A composite GI tolerability score was then calculated as the sum of each individual symptom score, with a range from 0 to 12 (representing complete tolerance and poor tolerance, respectively) (Maki et al, 2013;Stewart et al, 2018). Subjects also completed a bowel movement habit diary at baseline and over the two days preceding each clinic visit, recording bowel movement frequency, fecal consistency using the Bristol Stool Scale (scale of 1 [hard] to 7 [liquid]), and subjectively rating perceived fecal hardness (scale of 1 [soft] to 4 [very hard]), straining during bowel movement, discomfort during bowel movement, sensation of incomplete evacuation (all with a scale of 1 [none] to 4 [severe]) (Maki et al, 2013).…”