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What does it mean that Calorie Fighter is a medical device?

A medical device is products that are used to diagnose, prevent, relieve or treat illnesses, handicap or injuries. Slim Boost+ Calorie Fighter is CE-approved, which verifies that the device is compliant with the standard for medical devices and that the product’s quality, safety, and performance are documented.

Calorie Fighter is regulated by Lægemiddelstyrelsen / Klasse IIb – and prescription is not required! ALWAYS read the leaflet thoroughly before using the product.

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KiOnutrime-CsG® – The proven weight management tool

– by KitoZyme (2015)

Introduction

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, 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.

For the full study, click here.

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Re-evaluation of konjac gum (E 425 I) and konjac glucomannan (E 425 II) as food additives

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

Abstract

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.

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Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction

– by V. R. Trivedi et al. (2016)

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.

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Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality

– 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.

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Scientific Opinion on the substantiation of a health claim related to a standardized aqueous extract from white kidney bean

– 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.