Loss on drying:
Solubility in water:
C6 H12 O6
White to off-white fine-crystalline powder
ca. 230 ºC
stable under normal processing and storage conditions of foods and dietary supplements, no indications for undesired reactions or interactions with other food constituyents or ingredients of dietary supplements
Caromax syrup F+G, is a naturally occurring substance. It belongs to the group of inositols. They are a class of compounds which consists of nine distinct isomers. Inositols resemble six member ring simple sugars (i.e. glucose) but are not sugars but cyclic sugar alcohols. Inositols are, like simple sugars, a part of the normal human diet and as shown by the available evidence also non-toxic. Researchs have shown that DCI has distinct and interesting bioactivity which differentiates it from some other inositols.
DCI is found in several plants and fruits, in buckwheat, but also in carob and certain melons.
DCI is one of the inositols with physiological activity.
In the human body DCI is excreted as such. The clearance highly depends on the physiological state of the organism and it is significantly increased in diabetic people.
D-chiroinositol and glucose metabolism and diabetes
The hormone insulin is a key substance for the control of metabolism of glucose (blood sugar) in the body. A low insulin level results in the diabetes mellitus disease. Insufficient treatment of diabetes can cause different types of severe long-term damage to several parts of the human body. DCI seems to be a key substance for the positive effects on diabetes as non-insulin-dependent, diabetics were shown to have a ca. 5-fold higher and insulin-dependent diabetics even more than 30-fold higher excretion rate of this substance than healthy people. Compared to healthy persons, they have an extremely low level of DCI compound or lack of it completely. The insulin sensitivity and glucose tolerance in humans are inversely correlated to the excretion of DCI. Accordingly, the lack of DCI in diabetic patients may be an early marker for post-receptor insulin resistance in diabetes in general, including gestational diabetes. DCI is known to be an important secondary messenger in the insulin signal transduction.
A glycaninsulin mediator contains DCI and activates two key phosphoprotein phosphatases: pyruvate dehydrogenase phosphatase and glycogen synthase phosphatase 2C. These are the key rate limiting enzymes in insulin-stimulated glycogen and fat synthesis and therefore in maintaining healthy blood glucose levels.
Studies, often of the last few years, indicate that orally administered DCI may at least partially restore insulin sensitivity and glucose disposal and therefore to be beneficial in the treatment of diabetes mellitus.
DCI and polycystic ovary syndrome (PCOS)
Insulin resistance plays a key role in the pathophysiology of PCOS. A deficiency in a specific D-chiro-inositol-containing inositolphosphoglycan mediator may contribute to insulin resistance in women with PCOS. Study results indicate that the use of insulin-sensitizing agents in patients with PCOS may improve their sensitivity to the effects of insulin on glucose and lipid metabolism but also ameliorate clinical and biochemical manifestations. In one study women suffering from PCOS given 600 mg/d for 6 – 8 weeks in comparison to a placebo group DCI improved glucose tolerance, decreased serum androgens and improved ovulation. Insulin-sensitising therapy seems therefore a promising therapy for the treatment of PCOS, offering metabolic and gynaecologic benefits for women who suffer from this syndrome. Should favourable results with DCI be repeated, it could play a role in such therapies.
D-chiroinositol and fat metabolism and storage
Diabetes is often accompanied by abnormal lipid profiles. While DCI alone may already reduce elevated lipid levels, combination with other lipid-reducing agents may be beneficial.
DCI is apparently well tolerated by humans. Long-term DCI ingestion by humans from different plant foods which contain DCI like buckwheat or carob pods has not shown negative effects. Neither has a higher incidence of negative effects compared to placebo groups been reported from human studies with DCI of several hundred mg per person per day for several weeks. Based on the historical evidence it can reasonably concluded that the intake of a reasonable amount of DCI is safe.
DCI is often consumed for its physiological effects and therefore generally classified as a food and not as a food additive. Whenever specific pharmaceutical effects are claimed, products with DCI may be classified as a pharmaceutical and require a respective authorisation.
In the EU, DCI has been consumed as part of the normal diet by consumption of carob and soy products for decades if not centuries. Only consumption of well exceeding levels the intake from these sources may require examination whether the specific use has to be authorised. Health claims have to be approved by the EU under conditions outlined in Regulation 1924/2006/EC, especially art. 13 and 14. Claims going beyond a health claim require authorisation of DCI formulations as a pharmaceutical.
In Japan, DCI-containing products would be qualified by FOSHU (Foods for Specified Health Uses) responsible for the approval provided that the general requirements of effectiveness, safety, appropriate ingredients and adequate quality control are met.
In the USA, DCI is qualified for use in dietary supplements. Any claims on DCI functions have to be based on scientific evidence and to be accompanied by the following statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”. Any claim referring to treatment or cure of a disease makes a product a pharmaceutical which would require authorisation under pharmaceuticals legislation.
Euronutra is prepared to assist its customers in obtaining the necessary authorisations for their products.