Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: A double-blind, randomized, placebo-controlled, and dose-ranging trial.

Bifidobacterium animalis subsp. lactis HN019 (HN019) ameliorates chronic idiopathic constipation. Our aim was to determine the efficacy and safety of 28-day supplementation with 1 × 109 or 1 × 1010 CFU of HN019/day for constipation. A total of 228 adults who were diagnosed with functional constipation according to the Rome III criteria were randomized in a double-blind and placebo-controlled trial. Colonic transit time (CTT), the primary outcome, and secondary outcomes that were measured using inventories-patient assessment of constipation symptoms (PAC-SYM) and quality of life (PAC-QoL), bowel function index (BFI), bowel movement frequency (BMF), stool consistency, degree of straining, bowel emptying, bloating, and pain severity-were assessed. Ancillary parameters and harms were also evaluated. There were no statistically significant differences in the primary or secondary outcomes between interventions. A post hoc analysis of 65 participants with fewer than 3 bowel movements per week (BMF ≤ 3/week) showed a physiologically relevant increase in weekly BMF in the high- (+2.0) and low-dose (+1.7) HN019 groups-by RMANOVA, the HN019 groups with BMF ≤ 3/week, pooled together, had a higher BMF versus placebo (P value = 0.01). Thus, improving low stool frequency could be a target of future interventions with HN019. High-dose HN019 also decreased the degree of straining at Day 28 versus placebo in those with BMF ≤ 3/week (P value = 0.02). Three unlikely related AEs-2 with low-dose HN019 and 1 with placebo-were followed until full recovery. In conclusion, although there were no differences in the primary analysis, HN019 is well tolerated and improves BMF in adults with low stool frequency.

A High Rate of Non-Compliance Confounds the Study of Whole Grains and Weight Maintenance in a Randomised Intervention Trial-The Case for Greater Use of Dietary Biomarkers in Nutrition Intervention Studies.

Observational studies consistently find an inverse relationship between whole-grain intake and weight gain. We aimed to confirm this in an open-label researcher-blinded parallel design randomised trial. A total of 179 overweight/obese women with a habitually low whole-grain intake (<16 g/day) were randomised to a weight maintenance diet with refined-grain (RG) or whole-grain (WG) foods (80 g/day) for 12 weeks after an initial weight loss program over 8 weeks. Body weight and composition was assessed at baseline, after the initial weight loss, and after the 12-week dietary intervention. During the 12-week dietary intervention phase, there were no group differences in changes in body weight and total fat mass %, whereas abdominal fat mass tended to increase more during the dietary intervention phase in the WG compared to the RG group (0.7 (SD 3.6) vs. -0.3 (SD 3.8) %; p = 0.052). Plasma alkylresorcinol concentrations, biomarkers of wholegrain wheat and rye intake, indicated poor compliance, particularly in the WG group, where >60% of participants had alkylresorcinol concentrations below 70 nmol/L, a concentration indicating low or no intake of whole-grain wheat. Further, weight regain was lower than expected in both intervention groups, further supporting a lack of compliance to the post-weight-loss diet. The rate of compliance was too low to conclude any effect of whole grain on weight maintenance, and reinforces the need to use objective measures of compliance in nutrition intervention studies.

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.