Tapioca Resistant Maltodextrin as a Carbohydrate Source of Oral Nutrition Supplement (ONS) on Metabolic Indicators: A Clinical Trial

Tapioca resistant maltodextrin (TRM) is a novel non-viscous soluble resistant starch that can be utilized in oral nutrition supplements (ONS). This study aims to evaluate acute and long-term metabolic responses and the safe use of ONS containing TRM. This study comprised of two phases: In Phase I, a randomized-cross over control study involving 17 healthy adults was conducted to evaluate three ONS formulations: original (tapioca maltodextrin), TRM15 (15% TRM replacement), and TRM30 (30% TRM replacement). Plasma glucose, serum insulin, and subjective appetite were evaluated postprandially over 180 min. In Phase II, 22 participants consumed one serving/day of ONS for 12 weeks. Blood glucose, insulin, lipid profile, and body composition were evaluated. Gastrointestinal tolerability was evaluated in both the acute and long-term period. During phase I, TRM30 decreased in area under the curve of serum insulin by 33.12%, compared to the original formula (2320.71 ± 570.76 uIU × min/mL vs. 3470.12 ± 531.87 uIU × min/mL, p = 0.043). In Phase II, 12-week TRM30 supplementation decreased HbA1C in participants (from 5.5 ± 0.07% to 5.2 ± 0.07%, p < 0.001), without any significant effect on fasting glucose, insulin, lipid profile, and body composition. The ONS was well-tolerated in both studies. TRM is therefore, a beneficial functional fiber for various food industries.     

Endocrine therapy and palbociclib within a compassionate use program in heavily pretreated hormone receptor-positive,HER2-negative metastatic breast cancer

This is a single center retrospective analysis of patients with hormone receptor-positive, HER2-negative metastatic breast cancer progressing after ≥ 4 treatment lines treated with palbociclib in combination with endocrine therapy within a compassionate use program. Thirty-four patients were included between 10/2015 and 02/2017, the majority (82.4%) being previously treated with mTOR inhibitors. Disease control rate was 52.9% and 24.4% at week 12 and 24. Overall progression-free survival was 3.1 months with no difference between mTOR inhibitor-pretreated (3.5 months) and -naïve patients (2.7 months; hazard ratio, 0.83). Toxicity profile in this population was comparable to that seen in previous trials.     

A double-blind, placebo-controlled study of antidepressant augmentation with mirtazapine.

BACKGROUND: A previous pilot study of open-label mirtazapine augmentation conducted by the authors in 20 depressed patients yielded a 55% response rate at week 4. A double-blind controlled trial was undertaken to further elucidate the efficacy of this intervention. METHODS: 26 adult outpatients with persistent major depression despite adequate antidepressant monotherapy were randomized to receive 4 weeks of mirtazapine or placebo augmentation. Mirtazapine was begun at 15 mg at bedtime, with possible titration to 30 mg at bedtime per physician's discretion after week 1. RESULTS: Categorical positive response rate at end point was 64% for active drug and 20% for placebo. Remission rates were 45.4% and 13.3% for active drug and placebo groups, respectively, Mirtazapine demonstrated statistically significant superiority to placebo on most major outcome measures, and was associated with improvement in overall functioning and quality of life. There were no significant group differences with regard to emergent side effects, weight change, or serum concentrations of primary antidepressants. CONCLUSIONS: Mirtazapine appears safe and effective for short-term antidepressant augmentation.