Metabolic Syndrome is a pathology characterized by the presence of metabolic disorders (insulin resistance, dyslipidemia and hypertension), associated with anthropometric parameters alterations (overweight, abdominal obesity), interconnected factors that directly increase the risk of developing cardiovascular diseases and type 2 diabetes mellitus.
Contributes to normal energy metabolism.
In combination with a properly balanced diet and a healthy lifestyle, it promotes weight control, a reduction in the sense of hunger and the normalisation of alterations typical of obesity and metabolic syndrome.
Limenorm® - Totally Natural
Limenorm® is a blend of cocoa bean fibre (Theobroma cacao L.) and Sweet Orange Essential Oil (Citrus aurantium var. dulcis Hayne) with a high Limonene content.
Cacao supports metabolic activity and normal mood. Orange Essential Oil may support digestive function and the elimination of intestinal gas. Limonene has a selective antimicrobial action, with beneficial effects on the intestinal microbiota. Cocoa fibre contains flavonoids with antioxidant action and contributes to the product’s eubiotic activity.
Limenorm® can be used as a raw material for food supplements with eubiotic action to restore proper energy metabolism.
Preclinical scientific studies in a mouse model of obesity have demonstrated the efficacy of Limenorm® in positively modulating the intestinal microbiota by reducing the presence of specific bacterial strains that negatively impact blood levels of triglycerides and glucose. A randomised, double-blind clinical trial in patients suffering from Metabolic Syndrome is currently underway.
Patented in Europe
Limenorm® is the second patent designed entirely by Targeting Gut Disease S.r.l. The patent covers the formulation and its manufacturing technology (European Patent Application n°20178426.1).
What is Metabolic Syndrome?
What are gut Microbiota and Microbiome?
Gut Microbiota is the largest population of microorganisms (bacteria, fungi and viruses) that resides in the intestine and, living in symbiosis with our body, plays a crucial role in maintaining metabolic homeostasis, regulating the immune system and protecting against pathogens invasion.
The term Microbiome, instead, refers to the genetic inheritance of the microbiota, interpreted as the whole genes and their functions.
What does “Dysbiosis” mean?
Dysbiosis is an intestinal condition characterized by an alteration in the composition of the microbiota, associated with many inflammatory diseases, infections and metabolic-functional disorders, including the Metabolic Syndrome. In preclinical models it has been demonstrated that the alterations of the gut microbiota are sufficient to induce obesity and Metabolic Syndrome.
Limenorm® works by counteracting gut microbiota changes which are at the basis of weight gain, excessive fat accumulation and blood sugar and pressure elevation, to help restore the correct energy metabolism.
What does "Eubiotic" mean?
The term “Eubiotic” derives from the Greek word “Eubiosis”, which indicates a condition of optimal balance of the microflora in the gastrointestinal tract. Eubiotics are, in fact, positive modulators of the gut microbiota and, among these, there are several natural substances, such as some essential oils.
Limenorm® is an innovative raw material for food supplements with eubiotic action. It cannot be considered a probiotic or a prebiotic, as it does not remain to colonize the gastrointestinal tract and does not help other microorganisms to grow. It is not even an antibiotic, because it is not able to kill all microorganisms but it acts selectively by inhibiting the growth of only potentially pathogenic ones, the so-called “opportunistic pathogens”. These are commonly found in the intestine but can cause problems when they grow above a particular level. Therefore, the eubiotic action helps to keep them at the right concentrations, without affecting the “good” commensal bacteria, contributing to the microbiome rebalancing.
Which are the health benefits of the ingredients used in the product?
Orange Essential Oil can help maintain digestive function and eliminate intestinal gas. Furthermore, Limonene has a selective antimicrobial action with beneficial effects on the gut microbiota. Cocoa supports metabolic activity and promotes normal mood. In addition, Cocoa fiber promotes intestinal balance.
In what way is the product innovative?
The innovative Limenorm® formulation is based on the use of Cocoa fiber as an adsorption substrate to allow the Orange Essential Oil to pass intact through the first tract of the intestine and reach the colon where, following the degradation of the fiber by the gut microbiota, it is released in a high percentage, favoring microbial community natural rebalancing.
Is the product formulation patented?
The Limenorm® formulation and its production technology are patented (European patent application n° 20178426.1).
Has the product been tested?
Yes, Limenorm® was developed and patented by Targeting Gut Disease (TGD) Srl, a spin-off of the University of Bologna, which tested the formulation in preclinical studies (Valerii et al., 2021) and on the human microbiota and microbiome (Nissen et al., 2021).
Preclinical scientific studies were conducted on a mouse model of obesity induced by a high-fat diet and demonstrated Limenorm® efficacy in positively modulating the gut microbiota, reducing the presence of specific bacterial strains that negatively impact on triglycerides and glucose blood levels. The results on the human microbiota and microbiome also revealed that Limenorm® action is able to rebalance the microbial metabolism.
A randomized and double-blind clinical trial on patients with Metabolic Syndrome is currently underway at the S. Orsola-Malpighi Polyclinic of the University of Bologna.
In what form is the product sold?
Targeting Gut Disease (TGD) has developed Limenorm® as a raw material to be used alone or in combination with other ingredients in food supplements. As a raw material, the product is sold in the form of a hygroscopic powder. Limenorm® is also available as a ready-made food supplement, Liporange Complex®, to be used directly from consumers, in the form of sachets containing 2 g of Limenorm®.
Is Liporange Complex® comparable to "slimming / fat burning / thermogenic / metabolism booster" products or an alternative to "antidiabetic / antihypertensive / lipid-lowering" drugs, etc.?
No, Liporange Complex® is an innovative food supplement indicated to counteract gut microbiota modifications which are at the basis of weight gain, excessive fats accumulation and blood sugar and pressure elevation (characteristic alterations of the Metabolic Syndrome), favoring the correct energy metabolism restoration. Its mechanism of action is, therefore, different from that of the typical “slimming / fat burning / thermogenic / metabolism booster” products already on market and its effects are mostly mediated by the microbiome. Like any food supplement, Liporange Complex® cannot be considered a medicinal, therefore it is not intended for the treatment of pathological conditions and cannot represent a therapeutic alternative to “antidiabetic / antihypertensive / lipid-lowering” drugs, etc.
The use of Liporange Complex® is recommended for overweight/obese subjects, within a healthy lifestyle and in combination with an adequate low-calorie diet or following it to avoid weight rebound.
Is the product registered?
TGD has registered the product at the Italian Ministry of Health.
What is the recommended daily dose?
The recommend daily dose is one sachet of Liporange Complex®, diluted in at least 100 ml of water or other beverage, preferably half an hour before one of the three main meals.
What is each ingredient’s dosage in the mix?
Each ingredient’s average contents per daily dose are as follows:
|Average Contents||Per daily dose|
Sweet Orange Essential Oil
What is the nutritional information?
The nutritional information per 100 g of product is as follows:
|Nutritional information||Per 100 g|
|Energy||292 kcal / 1221 kJ|
Does the product contain gluten?
The Liporange Complex® basic ingredients – Cocoa Fiber and Orange Essential Oil – do not naturally contain gluten. However, the production chain is not certified as gluten free, therefore, Liporange Complex® may have traces of gluten due to “contamination” deriving from its production process.
Is the product vegan?
No, the product cannot be considered vegan. Despite the fact that the basic ingredients – Cocoa Fiber and Orange Essential Oil – used in Liporange Complex® are vegan per se, the production process is not certified as vegan.
Is the product GMO-free?
Yes, the product is GMO free. It does not contain, does not derive from and does not consist of Genetically Modified Organisms.
Liporange Complex® is in agreement with EC Regulations n. 1829/2003 and n. 1830/2003.
-Regulation (EC) n. 1829/2003 of the European Parliament and of the Council, of 22 September 2003, on genetically modified food and feed;
-Regulation (EC) n. 1830/2003 of the European Parliament and of the Council, of 22 September 2003, concerning to the traceability and labeling of genetically modified organisms and the traceability of food and feed products obtained from genetically modified organisms.
Does the product have any side effects? Could it be toxic in any way?
Preliminary studies conducted on an experimental mouse model and on humans have shown that the components of Liporange Complex® are safe.
Cocoa powder is widely used in the food industry and has never shown signs of toxicity at the dosages used in the supplement.
Limonene is classified as safe by both the Food and Drug Administration (FDA) and EFSA, and the dose considered to have no adverse effects (No Observed Adverse Effect Level – NOEL) is 1.000 mg/kg per day.
Since specific studies are not available, as a precaution it is best to avoid taking Liporange Complex® during pregnancy, lactation and in childhood. It is not recommended to take it even in case of renal or hepatic insufficiency, because the metabolism of essential oils and their derivatives essentially depends on liver and kidneys.
Is there a regulatory framework covering the product’s ingredients?
Yes, there is a wide European regulatory framework covering the product’s ingredients. The General Food Law Regulation (EC Regulation No. 178/2002 of the European Parliament and of the Council) established its principles and provided for the creation of an independent organization called European Food Safety Authority (EFSA), with the specific task of giving advice based upon scientific assessment of the beneficial health effects and risks associated with foods intake.
Citrus aurantium var. dulcis Essential Oil and Theobroma Cacao seeds powder are certified for food use.
According to the DM 27/03/2014, the essential oil of Citrus aurantium var. dulcis use is approved in food supplements for digestive function and intestinal gas elimination.
Limonene is considered a food flavoring and is, therefore, governed by Regulation (EC) n. 1334/2008 of the European Parliament and of the Council of 16 December 2008, relating to flavorings and certain food ingredients with flavoring properties intended for use in and on foods.
According to the DM 03/27/2014, the seeds of Theobroma Cacao use is approved in antioxidant food supplements, for metabolic support and normal mood maintenance.
According to Regulation (EC) n. 1924/2006 of the European Parliament and of the Council of 20 December 2006, relating to nutritional and health claims made on food products, Liporange Complex® can be defined as “high in fibre”.
According to Regulation (EU) n. 2015/2283 of the European Parliament and of the Council of 25 November 2015 relating to Novel Foods, Liporange Complex® does not meet the definition of “Novel Food”.
According to Regulation (EC) n. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Agency for Chemicals, Liporange Complex® is composed 100% by a mixed ingredients that meet the definition of “naturally occurring substances”.
Where does each ingredients’ feedstock come from?
The ingredients’ feedstock of Liporange Complex® come from Africa/South America (Cocoa) and Europe (Orange Essential Oil), their native environments; while their processing takes place in Italy.
The raw materials’ quality is double-checked:
- Cocoa and Orange Essential Oil arrive in Italy with their own certifications of analysis. Distributors check these certifications while conducting their quality assurance and quality control procedures;
- Raw materials are also checked in the final product. Manufacturers conduct several tests on the final product ingredients’ composition, including for example testing for pesticides, mycotoxins, allergens, Salmonella, coli and much more.
How is the production process organized?
1) Cocoa seeds are dried and turned into powder in Italy;
2) Sweet Orange Essential Oil, high in Limonene, is added to the blend and absorbed into the powder in Italy;
3) The base mixture (Limenorm®) is formulated;
4) In the ready-made food supplement (Liporange Complex®), excipients are added to the mixture to improve its formula and palatability.
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