Fat-Soluble Vitamins in Standard vs. Liposomal Form Enriched with Vitamin K2 in Cystic Fibrosis: A Randomized Multi-Center Trial.

BACKGROUND: We aimed to assess a liposomal fat-soluble vitamin formulation containing vitamin K2 with standard treatment in cystic fibrosis (CF). METHODS: A multi-center randomized controlled trial was carried out in 100 pancreatic-insufficient patients with CF. The liposomal formulation contained vitamin A as retinyl palmitate (2667 IU daily) and beta-carotene (1333 IU), D3 (4000 IU), E (150 IU), K1 (2 mg), and K2 as menaquinone-7 (400 µg). It was compared with the standard vitamin preparations in the closest possible doses (2500 IU, 1428 IU, 4000 IU, 150 IU, 2.14 mg, respectively; no vitamin K2) over 3 months. RESULTS: Forty-two patients finished the trial in the liposomal and 49 in the control group (overall 91 pts: 22.6 ± 7.6 years, 62.6% female, BMI 19.9 ± 2.8 kg/m2, FEV1% 70% ± 30%). The main outcome was the change of vitamin status in the serum during the study (liposomal vs. standard): all-trans-retinol (+1.48 ± 95.9 vs. -43.1 ± 121.4 ng/mL, p = 0.054), 25-hydroxyvitamin D3 (+9.7 ± 13.4 vs. +2.0 ± 9.8 ng/mL, p = 0.004), α-tocopherol (+1.5 ± 2.5 vs. -0.2 ± 1.6 µg/mL, p < 0.001), %undercarboxylated osteocalcin (-17.2 ± 24.8% vs. -8.3 ± 18.5%, p = 0.061). The secondary outcome was the vitamin status at the trial end: all-trans-retinol (370.0 ± 116.5 vs. 323.1 ± 100.6 ng/mL, p = 0.045), 25-hydroxyvitamin D3 (43.2 ± 16.6 vs. 32.7 ± 11.5 ng/mL, p < 0.001), α-tocopherol (9.0 ± 3.1 vs. 7.7 ± 3.0 µg/mL, p = 0.037), %undercarboxylated osteocalcin (13.0 ± 11.2% vs. 22.7 ± 22.0%, p = 0.008). CONCLUSION: The liposomal fat-soluble vitamin supplement containing vitamin K2 was superior to the standard form in delivering vitamin D3 and E in pancreatic-insufficient patients with CF. The supplement was also more effective in strengthening vitamin K-dependent carboxylation, and could improve vitamin A status.

The Effect of Sodium Butyrate Enemas Compared with Placebo on Disease Activity, Endoscopic Scores, and Histological and Inflammatory Parameters in Inflammatory Bowel Diseases: A Systematic Review of Randomised Controlled Trials.

INTRODUCTION: Administration of butyrate enemas might improve the health status of patients with inflammatory bowel disease (IBD). However, the results seem equivocal. Therefore, this systematic review aimed to assess the effect of sodium butyrate enemas on disease activity index (DAI), endoscopic scores, as well as histological and inflammatory parameters in IBD patients. METHODS: The PubMed, Scopus, Web of Science, and Cochrane databases were searched. Randomised controlled trials published in English that assessed the effect of butyrate enemas on DAI, clinical symptoms, inflammatory markers, as well as histological and endoscopic scores in patients with Crohn's disease (CD) and ulcerative colitis (UC) were included in the analysis. RESULTS: Eight studies involving 227 UC patients were included in this analysis. Only one study reported significant differences in DAI between groups. Besides, butyrate treatment groups did not differ significantly from controls concerning the effect on endoscopic and histological scores. Moreover, butyrate enemas exerted a significant effect on few inflammatory parameters measured in colonic mucosal biopsies. CONCLUSION: The current evidence is limited and does not support the application of butyrate enemas in UC. There are no reliable data regarding the efficacy of butyrate enemas in CD. The systematic review protocol was registered in the PROSPERO database (CRD42020163654).

Mulberry leaf extract decreases digestion and absorption of starch in healthy subjects-A randomized, placebo-controlled, crossover study.

PURPOSE: Mulberry (Morus alba L.) leaf tea has recently received much attention as a dietary supplement due to the wide range of putative health benefits, such as antidiabetic effects. Nevertheless, data evaluating its influence on carbohydrate metabolism in humans are scarce. The present study aims to investigate the effect of mulberry leaf extract supplementation on starch digestion and absorption in humans. MATERIALS AND METHODS: The study comprised of 25 healthy subjects, aged 19-27 years. In all subjects, a starch 13C breath test was performed twice in a crossover and single blind design. Subjects were initially randomized to ingest naturally 13C-abundant cornflakes (50g cornflakes+100ml low fat milk) either with the mulberry leaf extract (36mg of active component-1-deoxynojirimycin) or the placebo and each subject received the opposite preparation one week later. RESULTS: The cumulative percentage dose recovery was lower for the mulberry leaf extract test than for the placebo test (median [quartile distribution]: 13.9% [9.9-17.4] vs. 17.2% [13.3-20.6]; p=0.015). A significant decrease was detectable from minute 120 after the ingestion. CONCLUSIONS: A single dose of mulberry leaf extract taken with a test meal decreases starch digestion and absorption. These findings could possibly be translated into everyday practice for improvement of postprandial glycemic control.