Testing functional benefits

Subjects were randomly assigned to consume daily 70 g of normal dried rye bread (placebo group, = 30), rye bread in which 8% of the rye flour was substituted with phloem powder (low phloem, LP, group, = 30) or bread in which 14% of the rye flour was substituted with phloem powder (high phloem, HP, group, n = 15). Study breads used in our study were different in fiber, lignan and catechin content. The nutrient content of the phloem powder and 

In our study we used serum enterolactone as a marker of bioavailability of phloem polyphenols from the wood matrix. As a result of the four-week 

Substantial individual differences were observed in the response to study breads and the ranges of enterolactone concentration changes in the groups were as follows -54.5-60.0 nmol/1 (placebo), -26.2-101.3 nmol/1 (LP), -19.6-81.8 nmol/1 (HP). This was something that could have been expected as in several studies dietary factors have explained only 10% of the variation in serum enterolactone (Vanharanta et al, 2002b Kilkkinen et al., 2001). This gives further support to the major role of intestinal bacteria in the synthesis of enterolactone. Decreased concentrations of enterolactone may occur due to an increased fiber intake, which may shorten the retention time in the colon and lead to incomplete metabolism of plant lignans. Constipation was earlier shown to be associated with an increased level of serum enterolactone (Kilkkinen et al., 2001). 

In our study, consumption of rye bread or rye bread with phloem did not have an effect on serum lipids (total, LDL or HDL cholesterol or triglycerides) (Table 14.4). This is contrary to a recent finding suggesting that soluble fiber from rye bread decreased the concentrations of cholesterol (Leinonen et al., 2000). In that study ingestion of rye bread (220 g/d) with naturally high amounts of insoluble (18 g/d) and soluble fiber (4 g/d) decreased the LDL concentrations by 8% in hypercholesterolemic men. The researchers speculated that soluble fiber, maybe P-glucan, was responsible for the hypocholesterolemic effect. The amount of rye bread (70 g/d vs 220 g/d), the amount of total (5.9-11.8 g/d vs 22.1 g/d) and soluble fiber (0.6-1.3 g/d vs 4 g/d) ingested in this study was considerably less, and could explain the lack of effects on blood lipids in our study. 

Despite the fact that phloem is rich in catechins the amount of these ingested daily in our phloem study was rather small when compared to previously conducted studies. In similar studies the amount of catechins ingested in the form of tea or red wine per day has varied from 81 mg to as high as 2490 mg (de Rijke et al., 1996 Carbormeau et al., 1997 Nigdikar et al., 1998 Princen et al., 1998). It would be interesting to test in the future whether increasing the ingested amount of phloem would further reduce the inhibition of lipid peroxidation. 

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The development and testing function may be part of the analyst s responsibility or may reside with a separate group. The former can be beneficial because it adds to the challenge of the analyst s work and draws on the analyst s knowledge of the specific process, but requires that management allot sufficient time to perform both routine and research functions. The latter approach may benefit from the broad knowledge of specialists devoted entirely to development and testing. 

Reticulated Bacterial Cellulose. A cellulose with an intertwined reticulated structure, produced from bacteria, has unique properties and functionalities unlike other conventional celluloses. When added to aqueous systems, reticulated bacterial cellulose improves the fluid rheology and the particle suspension over a wide range of conditions [1836]. Test results showed advantages in fluid performance and significant economic benefits by the addition of reticulated bacterial cellulose. 

Eplivanserin (39) is a 5-HT2A antagonist initially developed for a broader spectrum of psychiatric disorders but that has been tested recently for insomnia. Within this latter indication, phase II studies showed benefits in sleep maintenance, but not in induction [9]. Compound 39 is currently in phase III, to assess the efficacy for the treatment of sleep maintenance insomnia, evaluating both sleep and daytime functioning [96]. 

Sexual function One of the potential benefits of hypericum is the apparent reduced or lack of adverse effects upon sexual function, compared to pharmaceutical antidepressants. The SSRIs are particularly notorious for inhibition of sexual function, whereas antidepressants with dopaminergic actions (e.g., bupropion) do not, and may actually enhance sexual function (Rosen et al. 1999 Piazza et al. 1997). Anecdotal reports and the fact that there are no clinical reports of sexual dysfunction with hypericum is encouraging, but it remains to be tested empirically. 

Hepatotoxicity Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease, nor a serious underlying medical condition. If liver function tests are abnormal, discontinue treatment. In patients with raised liver enzymes or an active liver disease or who have experienced liver toxicity with other drugs, do not start treatment unless the expected benefit exceeds the risk of hepatic injury. In such cases, liver enzyme monitoring is necessary. 

Monitor patients who develop abnormal liver function tests during concomitant therapy with cyclosporine, and evaluate the risk/benefit of continuing therapy. Pregnancy Category C. 

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