Probíhající klinické studie a profesionální spolupráce

Abstract

- by European Food Safety Authority (EFSA) (2017)

The present opinion deals with the re-evaluation of konjac (E 425), comprising konjac gum (E 425 i) and konjac glucomannan (E 425 ii) when used as food additives. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that current use of konjac (E 425) was limited in all food categories to maximum permitted level (MPL) of 10 g/kg, and that the calculated indicative refined exposure assessment for all population groups was below 0.1 mg/kg body weight (bw) per day for the general population (mean and high level). Konjac gum and konjac glucomannan were unlikely to be absorbed intact and were significantly fermented by intestinal microbiota. The available database on toxicological studies was considered limited, however, no relevant adverse effects were seen in rats and dogs in 90-day feeding studies according to the SCF, the no-observed-effect level (NOEL) in rats being 1,250 mg konjac glucomannan/kg bw per day. Konjac gum and konjac glucomannan were of no concern with respect to the genotoxicity. After a daily dosage of 3,000 mg in adults for 12 weeks, several individuals experienced abdominal discomfort including diarrhoea or constipation. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that there was no safety concern for the general population at the refined exposure assessment for the reported uses of konjac gum (E 425 i) and konjac glucomannan (E 425 ii) as food additives under the current conditions of use of 10 g/kg. The Panel agreed with the conclusions of the SCF (1997) that the uses of konjac (E 425) as an additive at the levels up to 10 g/kg in food are acceptable, provided that the total intake from all sources stays below 3 g/day.

For the full study, click here

Abstract

Chitosan is a dietary fiber that acts by reducing absorption and thus as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of chitosan from the fungal origin in the treatment of excess weight in the absence of dietary restrictions. For the full study, click here.

- af KitoZyme (2015)

Introduktion

KiOnutrime-CsG® is a natural ingredient that is scientifically proven to help people to manage their weight. In a recently completed clinical trial1, it was found that overweight subjects consuming KiOnutrime-CsG® lost an average of 3.2kg over three months. This is compared with a small weight increase on average in the control group.

Produced by KitoZyme at its manufacturing facility in Belgium, KiOnutrime-CsG®, works by safely preventing some of the fat in food from being absorbed by the body. It is a cationic (positively charged) biopolymer that binds with anionic (negatively charged) molecules, such as fats and fatty acids and obstructs the emulsification and absorption of cholesterol. Taken just a few minutes before a meal, KiOnutrime-CsG® will bind dietary fat in the stomach to form a gel that is later excreted naturally without being absorbed. A previous study carried out using a lab-based model of the human gut, showed that KiOnutrime-CsG® can bind 42% of the fats ingested in a typical meal2, as shown below in Figure 1. The latest human study, which is awaiting publication in a peer-reviewed journal, confirms that this mechanism has a statistically significant impact on weight loss in healthy overweight people.

Read more about the studies here, click here.

- by C. Di Lorenzo et al. (2014)

Aims

The objective of this review was to collect available data on the following: (i) adverse effects observed in humans from the intake of plant food supplements or botanical preparations; (ii) the misidentification of poisonous plants; and (iii) interactions between plant food supplements/botanicals and conventional drugs or nutrients.

Methods

PubMed/MEDLINE and Embase were searched from database inception to June 2014, using the terms ‘adverse effect/s’, ‘poisoning/s’, ‘plant food supplement/s’, ‘misidentification/s’ and ‘interaction/s’ in combination with the relevant plant name. All papers were critically evaluated according to the World Health Organization Guidelines for causality assessment.

Results

Data were obtained for 66 plants that are common ingredients of plant food supplements; of the 492 papers selected, 402 (81.7%) dealt with adverse effects directly associated with the botanical and 89 (18.1%) concerned interactions with conventional drugs. Only one case was associated with misidentification. Adverse effects were reported for 39 of the 66 botanical substances searched. Of the total references, 86.6% were associated with 14 plants, including Glycine max/soybean (19.3%), Glycyrrhiza glabra/licorice (12.2%), Camellia sinensis/green tea ( 8.7%), and Ginkgo biloba/ginkgo (8.5%).

Conclusion

Considering the length of time examined and the number of plants included in the review, it is remarkable that: (i) the adverse effects due to botanical ingredients were relatively infrequent if assessed for causality; and (ii) the number of severe clinical reactions was very limited, but some fatal cases have been described. Data presented in this review were assessed for quality in order to make the results maximally useful for clinicians in identifying or excluding deleterious effects of botanicals. For the full study, click here.

- by European Food Safety Authority (EFSA) (2014)

Abstract

Following an application from InQpharm Europe Ltd, submitted for authorization of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a standardized aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. The Panel considers that the food is sufficiently characterized. A reduction in body weight is a beneficial physiological effect for overweight individuals. The applicant identified a total of four human intervention studies which investigated the effects of the aqueous extract from white kidney bean on body weight as being pertinent to the claim. No conclusions could be drawn from two of these four studies. In weighing the evidence, the Panel took into account that one human intervention study showed an effect of the standardised aqueous extract from white kidney bean in reducing body weight when consumed for 12 weeks, that the reduction in body weight was mostly through a reduction in body fat and that the effect of the standardized aqueous extract from white kidney bean on body weight was supported by a second study of shorter duration. However, the Panel also took into account that the first study was at risk of bias, that the supportive study suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardized aqueous extract from white kidney bean could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of the standardized aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. For the full study, click here.

- by European Medicines Agency (2012)

Introduction

Ginger (Zingiberis rhizoma) consists of the whole or cut rhizome of Zingiber officinale Roscoe (Zingiberaceae), with the cork removed, either completely or from the wide, flat surfaces only [European Pharmacopoeia 2011]. Ginger plants have been extremely popular – for cooking as spice and to treat a host of ailments – throughout Asia, especially in India and China, for over 5000 years. The species Zingiber officinale originates from Southeast Asia. It is not known to occur wild [Teuscher 2006; Langner et al. 1998; Germer et al. 1997]. It is a perennial herb, up to 1.5 metre in height, with asymmetric flowers. Due to the long period of breeding in different continents, different types of the species have developed. The herbal substance ginger, that complies with the monograph of the European Pharmacopoeia, originates from the West Indian type (Jamaica-ginger) with the cork removed or from Indian types (Bengal-ginger, Cochin-ginger) peeled on the flattened sides only. Constituents: Volatile oil 1-4 % (minimum 15 ml/kg essential oil (anhydrous drug) according to the Ph. Eur.). More than 100 compounds are identified, most of them terpenoids mainly sesquiterpenoids (α-zingiberene, β-sesquiphellandrene, β-bisabolene, α-farnesene, ar-curcumene (zingiberol) and smaller amounts of monoterpenoids (camphene, β-phellandrene, cineole, geraniol, curcumene, citral, terpineol, borneol). The composition of the oil depends on the origin of the material [Afzal et al 2001; Ahmad et al. 2008; Ali et al. 2008; Chen & Ho 1988; Connell 1970; Erler et al. 1988; Lawrence 1984]. The pungent principles, the gingerols (4-7.5%) are a homologous series of phenols. The principal one of these is 6-gingerol. Gingerols with other chain-lengths, e.g., 8-gingerol and 10-gingerol, are present in smaller amounts. During drying and storage, gingerols are partly dehydrated to the corresponding shogaols which may undergo further reduction to form paradols, also present in stored ginger [Afzal et al. 2001; Bradley 1992; Connell 1970; Farthing & O’Neill 1990; Jolad et al. 2005; Kim et al. 2008; Steinegger & Stucki 1982]. Other constituents are starch, up to 50%, lipids 6-8%, proteins, and inorganic compounds [Awang 1992; ESCOP 2009]. The requirements of the US Pharmacopoeia for ginger are: gingerols and gingerdiones not less than 0.8%, volatile oil not less than 1.8 ml per 100 g, starch not less than 42% and shogaols not more than 0.18% [Bradley 1992; USP 2009]. For the full study, click here.

- by Gaurav Kumar et al. (2011)

Introduction

Herbs and plants have been in use as a source of therapeutic compounds in traditional medicinal system since ancient time. Medicines plants play an important role in traditional health care systems as well as in international herbal and pharmaceutical markets. The medicinal value of these plants lies in some chemical substances that produce a definite physiological action on the human body. The most important of these bioactive constituents of plants are alkaloids, tannins, flavonoids and phenolic compounds. Z. officinale (Zingiberaceae) is an important plant with several ethnomedicinal and nutritional values therefore, used extensively worldwide as a spice, flavouring agent and herbal remedy. Traditionally, Z. officinale is used in Ayurveda, Siddha, Chinese, Arabian, Africans, Caribbean and many other medicinal systems to cure a variety of diseases viz, nausea, vomiting, asthma, cough, palpitaion, inflammation, dyspepsia, loss of appetite, constipation, indigestion and pain. In last few decades, Z. officinale is extensively studied for its medicinal properties by advanced scientific techniques and a variety of bioactive compounds have been isolated from the different parts of the plant and were analysed pharmacologically. The plant is reported for antimicrobial activity, anticancer activity, antioxidant activity, antidiabetic activity, nephroprotective activity, hepatoprotective activity, larvicidal activity, analgesic activity, anti-inflammatory activity and immunomodulatory activities. The present review is focused an overall outline of the morphology, distribution, phytochemistry and medicinal properties of Z. officinale and its future prospects for the further scientific investigation for the development of effective therapeutic compounds. For the full study, click here.  

- by Mikkelsen, M. G. (2011).

Introduction

Dietary recommendations in heart failure management are contradictory to findings established by the obesity paradox. The objective of this study was to investigate if a weight reduction could reduce symptoms of heart failure; thus resulting in an improvement of body composition, plasma lipid profile, and functional status and thereby positively affect cardiac function.

Methods

We enrolled 26 obese patients with heart failure and NYHA II or III. They were randomly assigned to adhere to a low-calorie diet (Nupo VLCD: 700 kcal/day + 100 kcal of supplementary food) or a conventional diet for 12 weeks. In the study, we assessed body weight and -composition, plasma lipid profile, NT-proBNP, functional status, and quality of life.

Results

Of the 26 patients, 18 completed the study (11 in the intervention group and 7 in the control group). The mean weight loss with the low-calorie diet (LCD) was 11.3% of initial body weight and the difference in mean weight loss between the low-calorie diet group and conventional diet group was 11.7 kg at the end of the study (95% CI: 6.8, 16.6, p<0.0001). Patients following the low-calorie diet significantly reduced their body mass index (p<0.0001, 95% CI: 2.3, 5.3), waist circumference (p<0.0001, 95% CI: 5.9, 15.3), and hip circumference (p<0.0010, 95% CI: 5, 15.2,) compared to the patients following the conventional diet. The walking distance significantly improved between baseline and week 12, the between-group difference amounted to 172m after 12 weeks p<0.0005. There was a significant mean difference for cholesterol- (p<0.0006), triglyceride-(p<0.0100), and low-density lipoprotein (p=0.0265) concentrations between baseline and week 8. Mean differences in plasma lipid levels were not significant at week 12.

Conclusion

In this small pilot study, a low-calorie diet led to a significant improvement in body weight and -composition and functional status in patients with heart failure. Larger studies need to confirm these preliminary findings.

For the full study,click here.

- by European Food Safety Authority (EFSA) (2010)

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to konjac mannan (glucomannan) and reduction of body weight, reduction of post-prandial glycaemic responses, maintenance of normal blood glucose concentrations, maintenance of normal (fasting) blood concentrations of triglycerides, maintenance of normal blood cholesterol concentrations, maintenance of normal bowel function and decreasing potentially pathogenic gastrointestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from the Member States or directly from stakeholders. The food constituent that is the subject of the health claims is konjac mannan (glucomannan). The Panel considers that konjac mannan (glucomannan) is sufficiently characterized. For the full study, click here.