2 resultados para PLACEBO-CONTROLLED TRIALS

em Doria (National Library of Finland DSpace Services) - National Library of Finland, Finland


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Sea buckthorn (Hippophaë) berries are ingredients of the Chinese traditional medicine. In addition to China, they are nowadays cultivated for food in several European countries, Russia, Canada, the USA, and Japan. Sea buckthorn berries are a rich source of flavonoids, mainly flavonol glycosides and proanthocyanidins. Depending on the genetic background, growth conditions, and ripeness of the berries, vitamin C concentrations up to over 1 g/100 ml juice, have been reported. Sea buckthorn berries contain inositols and methyl inositols, components of messenger molecules in humans. Sea buckthorn seed oil is rich in essential aplha-linolenic and linoleic acids, whereas the most abundant fatty acids in the berry oil are palmitoleic, palmitic and oleic acids. Other potentially beneficial lipophilic compounds of sea buckthorn seeds and berries include carotenoids, phytosterols, tocopherols and tocotrienols. The effects of sea buckthorn fractions on inflammation, platelet aggregation, oxidation injuries, the liver, skin and mucosa, among others, have been reported. The aim of the thesis work was to investigate the health effects of sea buckthorn berries and oil in humans. The physiological effects of sea buckthorn berries, berry components, and oil have mostly been studied in vitro and in animal models, leaving a demand for more clinical trials. In the first randomized, placebo-controlled trial of this thesis healthy adults consumed 28 g/day of sea buckthorn berries for three months. The main objective was to investigate the effects on the common cold. In addition, effects on other infections, inflammation and circulating lipid markers associated with cardiovascular disease risk were studied. In the second randomized, placebocontrolled trial participants reporting dry eye symptoms consumed 2 g/day of sea buckthorn oil from the seeds and berries for three months. The effects on symptoms and clinical signs of dry eye were monitored. In addition, the effects on circulating markers of inflammation and liver functions were analyzed. Sea buckthorn berries did not affect the common cold or other infections in healthy adults. However, a decrease in serum C-reactive protein was detected, indicating effects on inflammation. Fasting concentrations of serum flavonols, typical to sea buckthorn berry, increased without affecting the circulating total, HDL, LDL cholesterol, or triacylglycerol concentrations. Tear film hyperosmolarity and activation of inflammation at the ocular surface are among the core mechanisms of dry eye. Combined sea buckthorn berry and seed oil attenuated the rise in tear film osmolarity taking place during the cold season. It also positively affected some of the dry eye symptoms. Based on the tear film fatty acid analysis, the effects were not mediated through direct incorporation of sea buckthorn oil fatty acids to tear film lipids. It is likely that the fatty acids, carotenoids, tocopherols and tocotrienols of sea buckthorn oil affected the inflammation of the ocular surface, lacrimal and/or meibomian glands. The effects on the differentiation of meibomian gland cells are also possible. Sea buckthorn oil did not affect the serum concentrations of inflammation markers or liver enzymes investigated. In conclusion, this thesis work suggests positive effects of sea buckthorn berries and oil on inflammation and dry eye, respectively, in humans.

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Despite over 50 years of investigation, the precise cause of infant colic crying remains unresolved and the long-term consequences unrevealed, and an effective treatment is lacking. Indeed, a more profound understanding of the complex nature of infants’ excessive crying is needed. The purpose of this series of studies was to investigate the association between gut microbiota composition and infant crying, to evaluate the impact of colic crying on children’s later health and to study the possibilities of treating and preventing excessive crying with pro- and prebiotics. The material comprised three on-going, prospective randomized controlled trials of the probiotic Lactobacillus rhamnosus GG (ATCC 53103, LGG) or a mixture of prebiotics administered in early infancy. The study populations consisted of term infants (n=89), preterm infants (n=94) and term colic infants (n=30). Early crying was found to be inversely associated with the number of Bifidobacterium and Lactobacillus. Furthermore, at the age of 13 years functional gastrointestinal disorders (FGID) were manifested more frequently among children with previous colic crying than in those without. In preterm infants pro- and prebiotic supplementation during the first months of life reduced the frequency of excessive crying when compared to placebo. In parallel, probiotic LGG in tandem with a cow’s milk elimination diet and behavioral counseling reduced the daily crying amount among term colic infants when compared to placebo. In conclusion, the composition of the gut microbiota is associated with infant crying and colic, and probiotic LGG might provide a safe and effective treatment or preventive option to alleviate excessive crying in early infancy in term and preterm infants. Furthermore, early colic crying might be associated with the later development of FGID.