Limenorm® - Totally Natural

In the majority of individuals, obesity is the result of modern lifestyle, which exposes each of us to an environment defined as ‘obesogenic,’ leading us to eat more, modify the quality of food, and engage in less physical activity. The intestinal microbiota also appears to play a significant role in the pathophysiology of obesity. Numerous studies show a link between intestinal dysbiosis and metabolic syndrome, due to the microbiota’s ability to modulate the host’s energy metabolism through the production of short-chain fatty acids from the fermentation and hydrolysis of polysaccharides (mainly fiber). These fatty acids can influence intestinal transit and the host’s sensation of satiety. The Western diet, characterized by high consumption of refined flours, red meat, saturated fats, sugars, processed foods, and insufficient fiber intake, significantly contributes to intestinal dysbiosis and a low-grade systemic inflammation, which are considered key elements in the development and maintenance of metabolic syndrome.

Orange Essential Oil, standardized in limonene, contributes to maintaining digestive function and eliminating intestinal gas. Some components of essential oils have a eubiotic action, which means selective antimicrobial, with beneficial effects on the balance of the intestinal microbiota. Cocoa supports metabolic activity and normal mood tone and contains flavanols, polyphenols with antioxidant properties.

The innovative formulation of Limenorm® is based on the use of a patented preparation of sweet orange essential oil adsorbed onto cocoa fiber. According to pharmacokinetic studies, this particular formulation allows it to pass through the first part of the intestine intact and reach the colon where, following the degradation of the fiber by the intestinal microbiota, the oil is released in high percentage and promotes the natural rebalancing of the microbial community.

Preliminary studies conducted on a murine experimental model and in humans have demonstrated the safety of Limenorm® components. Cocoa powder is widely used in the food industry and has never shown signs of toxicity at recommended dosages in the supplement. Limonene is classified as safe by both the Food and Drug Administration (FDA) and EFSA, with a dose considered to be without adverse effects (No Observed Adverse Effect Level – NOEL) being 1,000 mg/kg per day. Since specific studies are not available, it is advisable to avoid the consumption of products containing Limenorm® during pregnancy, breastfeeding, and in pediatric age as a precautionary measure. Its intake is also not recommended in case of renal or hepatic insufficiency, as the metabolism of essential oils and their derivatives is primarily dependent on the liver and kidneys.

Limenorm® has been developed and patented by TGD s.r.l., a spin-off of the University of Bologna, which has tested the formulation in preclinical studies (Valerii et al., 2021) and on human microbiota and microbiome (Nissen et al., 2021). Preclinical scientific studies were conducted on an animal model of obesity induced by a high-fat diet and demonstrated the effectiveness of Limenorm® in positively modulating the gut microbiota, reducing the presence of specific bacterial strains that negatively impact blood triglyceride and glucose levels. The results on human microbiota and microbiome also revealed that the action of Limenorm® is capable of rebalancing microbial metabolism. A randomized, double-blind clinical trial on patients with Metabolic Syndrome is currently underway at the S. Orsola-Malpighi Hospital, University of Bologna.

Limenorm® is GMO-free. It does not contain, derive from, or consist of Genetically Modified Organisms. Limenorm® is compliant with Regulations EC No. 1829/2003 and No. 1830/2003. In particular: Regulation (EC) No. 1829/2003 of the European Parliament and of the Council, dated 22 September 2003, on genetically modified food and feed; Regulation (EC) No. 1830/2003 of the European Parliament and of the Council, dated 22 September 2003, concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

The formulation of Limenorm® and its production technology are covered by the European patent EP 3919050A1.

The raw materials of Limenorm® are sourced from Africa/South America (Cocoa) and Europe (Orange Essential Oil), their native environments, while their processing takes place in Italy. The quality of the raw materials is checked twice: upon arrival in Italy, the analysis certifications are reviewed again by distributors and producers to verify the active ingredient content and the presence of pesticides, mycotoxins, allergens, and microbial load.

The cocoa seeds are dried and processed into powder in Italy. The Sweet Orange Essential Oil, high in Limonene content, is added to the mixture and absorbed into the powder in Italy. This is how Limenorm® powder is obtained.