Maggie Laidlaw

Yo Jyo Hen Shi Ko (YHK) improves transaminases in nonalcoholic steatohepatitis (NASH): a randomized pilot study.

NASH is a common condition with a rising incidence. There is progression to cirrhosis in some cases and the potential for mortality or requirement of liver transplantation. Currently, there is no approved therapy for NASH. The natural compound YHK has both anti-inflammatory and antifibrotic properties, and can lead to improvement in transaminases in viral hepatitis. Improvement in transaminases may correlate with improved histology in NASH and hence may impact on the natural history. We sought to determine the effects of YHK on NASH. We performed a randomized, double-blind, placebo-controlled pilot study to determine the effects of YHK on transaminases and on quality of life (QoL) in patients with biopsy-confirmed NASH and a persistently abnormal ALT or AST. Eight patients were randomized to YHK or placebo for 8 weeks. The ALT and AST were measured at baseline and weeks 4, 8, and 12. SF-36 surveys were serially completed. All five patients in the YHK group but none in the placebo group had a marked decrease in ALT at both week 4 and week 8 compared to baseline. After discontinuing YHK the ALT returned toward baseline at week 12. The mean decrease in ALT compared to baseline was significantly greater in the YHK group than in the placebo group at both week 4 (−42.8 ± 23.2 vs. −6.3 ± 6.7 U/L; P = 0.036) and week 8 (−45.4 ± 23.4 vs. 6.0 ± 24.6 U/L; P = 0.036). There was also a nonsignificant decrease in AST in the YHK group compared to placebo. QoL was not affected and no severe adverse events were reported. In this controlled pilot study we found the novel nutraceutical agent YHK to be effective at reducing ALT values in patients with NASH. YHK is well tolerated. Further studies are justified to assess the impact of YHK in the natural history of NASH.

Effects of a breast-health herbal formula supplement on estrogen metabolism in pre- and post-menopausal women not taking hormonal contraceptives or supplements: a randomized controlled trial.

Introduction Both indole-3-carbinol and dietary lignans have beneficial effects on estrogen metabolism and breast cancer risk. There is no published literature on the effects of a combination product. This study was designed to investigate the impact of a combination product on estrogen metabolism. The major trial objective was to determine whether a breast health supplement containing indole-3-carbinol and hydroxymatairesinol lignan would alter estrogen metabolism to favour C-2 hydroxylation and reduce C-16 hydroxylation. Higher concentrations of C-2 metabolites and lower concentrations of C-16 metabolites may reduce breast cancer risk and risk for other hormonally-related cancers. Methods Forty-seven pre-menopausal and forty-nine post-menopausal women were recruited for this study, and were divided by random allocation into treatment and placebo group. The treatment supplement contained HMR lignan, indole-3-carbinol, calcium glucarate, milk thistle, Schisandra chinesis and stinging nettle, and each woman consumed either treatment or placebo for 28 days. At day 0 and day 28, blood samples were analysed for serum enterolactone concentrations, and first morning random urine samples were assessed for estrogen metabolites. Repeated measures ANOVA statistical testing was performed. Results In pre-menopausal women, treatment supplementation resulted in a significant increase (P < 0.05) in urinary 2-OHE concentrations and in the 2:16α-OHE ratio. In post-menopausal women, treatment supplementation resulted in a significant increase in urinary 2-OHE concentrations. In pre- and post-menopausal women combined, treatment supplementation produced a significant increase in urinary 2-OHE concentration and a trend (P = 0.074) toward an increased 2:16α-OHE ratio. There were no significant increases in serum enterolactone concentrations in the treatment or placebo groups. Conclusions Supplementation with a mixture of indole-3-carbinol and HMR lignan in women significantly increased estrogen C-2 hydroxylation. This may constitute a mechanism for the reduction of breast cancer risk as well as risk for other estrogen-related cancers. Further studies with higher numbers of subjects are indicated. Trial Registration ClinicalTrials.gov registration #NCT01089049.

Development of a Standardized Clinical Protocol for Ranking Foods and Meals Based on Postprandial Triglyceride Responses: The Lipemic Index

Postprandial triglyceride levels are being increasingly recognized as an independent risk factor for the development of cardiovascular disease (CVD). There is a need for developing a standardized clinical protocol which allows foods and meals to be ranked based on the resulting postprandial triglyceride response. This pilot study offers a novel approach to standardize such testing based on equicaloric intakes, allowing for increased flexibility in comparing different food and meal offerings, as well as a high potential for public knowledge transfer. Our laboratory has developed a standardized 2100 kJ beverage, consisting of fat, protein, and simple carbohydrates (LIXR) with the goal of eliciting a reference postprandial triglyceride response. As we hypothesized, a certain commercial product which gave favourable glycemic responses yielded significantly higher triglyceride responses than our reference solution, indicating an important gap in current methods of identifying low-risk foods for subjects at risk for CVD. The lipemic index may eventually be used in combination with other nutritional tools to provide an enhanced overall assessment of health risks associated with consuming certain foods.