The impact of sitosterol formulation particle size on the intestinal sterol absorption and the sterol status in various tissues in Dunkin Hartley guinea pigs was investigated. Three groups of animals (six each) were fed a basal diet ("control") or a basal diet containing either customary sitosterol ("customary", particle size: 10 000-90 000 nm) or nanoscale sitosterol ("nanoscale", particle size: 200-300 nm). The average daily sitosterol intake was 21 +/- 7 mg (control), 154 +/- 8 mg (customary), and 127 +/- 18 mg (nanoscale) for 2 weeks. Sitosterol and cholesterol were analyzed in samples of plasma, blood cells, bile, liver, kidney, jejunal mucosa/serosa, cecum, colon and feces. Concentrations of sitosterol in all analyzed matrices increased significantly in the supplemented groups when compared to control group. No differences in the sitosterol concentrations in analyzed matrices occurred between nanoscale and customary group. The cholesterol concentrations in tissues remained unchanged. Fecal fatty acid and sterol distributions were modified during sitosterol intervention. Both particle sizes equally increased sitosterol levels in cholesterol-metabolizing compartments in the guinea pig. No differences in body compartment accumulation and intestinal absorption of the different sitosterol particle sizes were observed.
Berry seeds are a tocopherol-rich by-product of fruit processing without specific commercial value. In a human intervention study, the physiological impact of blackcurrant seed press residue (PR) was tested. Thirty-six women (aged 24^3 years; twenty non-smokers, sixteen smokers) consumed 250 g bread/d containing 8 % PR for a period of 4 weeks (period 3). Comparatively, a control bread without PR (250 g/d) was tested (period 2) and baseline data were obtained (period 1). Blood, stool and 24 h urine were collected during a 5 d standardised diet within each period. Tocopherol and Fe intakes were calculated from food intake. In serum, tocopherol concentration and Fe parameters were determined. In urine, oxidative stress markers 8-oxo-2 0 -deoxyguanosine, 8-iso-PGF 2a and inflammatory response marker 15-keto-dihydro-PGF 2a were analysed. Stool tocopherol concentration, genotoxicity of faecal water (comet assay) and antioxidant capacity of stool (aromatic hydroxylation of salicylic acid) were determined. Fe and total tocopherol intake, total tocopherol concentrations in serum and stool, and genotoxicity of faecal water increased with PR bread consumption (P,0·05). The antioxidant capacity of stool decreased between baseline and intervention, expressed by increased formation of 2,3-and 2,5-dihydroxybenzoic acid in vitro (P,0·05). In smokers, 8-oxo-2 0 -deoxyguanosine increased with PR consumption (P, 0·05). Prostane concentrations were unaffected by PR bread consumption. In summary, the intake of bread containing blackcurrant PR for 4 weeks increased serum and stool total tocopherol concentrations. However, various biomarkers indicated increased oxidative stress, suggesting that consumption of ground berry seed may not be of advantage.
Background Evidence from controlled trials has shown that lanreotide autogel is effective in achieving biochemical and symptom control in patients with acromegaly. However, it is important to better understand the real-world patient population receiving lanreotide autogel treatment.
Methods In this non-interventional study the long-term treatment response to lanreotide autogel in adult patients with acromegaly from office-based centers or clinics in Germany, Austria and Switzerland was studied. Assessments included growth hormone and insulin-like growth factor-I levels, symptoms, quality of life, lanreotide plasma levels and tumor somatostatin receptor subtype expression. The primary endpoint was achievement of full biochemical control, defined as growth hormone ≤2.5 µg/L and insulin-like growth factor I normalization at month 12.
Results 76 patients were enrolled from 21 sites. 7/51 (13.7%) patients of the efficacy population had full biochemical control at baseline, 15/33 (45.5%) at month 12 and 10/26 (38.5%) at month 24 of treatment. At 12 months of treatment higher rates of biochemical control were observed in the following subgroups: older patients (>53 years [median]), females, treatment-naïve patients, and patients with a time since diagnosis of longer than 1.4 years (median). No clinically relevant differences in acromegaly symptoms or quality of life scores were observed. Median fasting blood glucose and glycated hemoglobin levels remained unchanged throughout the study. No new safety signals were observed. Overall tolerability of treatment with lanreotide autogel was judged by 80.8% of the enrolled patients at month 12 as ‘very good’ or ‘good’.
Conclusion Treatment with lanreotide autogel in a real-world setting showed long-term effectiveness and good tolerability in patients with acromegaly.
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