Products – Bergacyn | DolCas Biotech

Bergamot & Cynara Extract

Clinically Proven Process & Use Patented

Bergamot & Cynara Extract

Clinically Proven Process & Use Patented

Bergacyn®FF is a patented extract blend of bergamot citrus and Cynara cardunculus, clinically proven to support normal liver fat levels and promote healthy weight loss in overweight individuals. Native to Italy’s southern coasts, Bergacyn®FF actives grow in a unique microclimate fostered by the abrupt contrast of the Appinnine Mountains and the Mediterranean Sea.

Excess liver fat accumulation and its consequences are a growing concern. Majorly driven by processed food intake, excess calories and sedentary lifestyle, fatty liver is estimated to affect over 25% of the population with aggressive growth predictions for the future, as Metabolic Syndrome and obesity reach all-time highs. Bergacyn®FF delivers an exclusive profile of polyphenols and sesquiterpenes that facilitate the ingredient’s action in promoting healthier liver fat metabolism and modulating the immune triggers that instigate downstream liver damage.

BergacynFF’s exclusive use of bergamot albedo (pulp) fibers and sesquiterpenes from the Cynara leave combine novelly to round out the rich polyphenol profile of 17% polyphenols, contributed to by all the formulation’s components. The pulp fibers act as synergistic bioenhancers (delivering 2.5-times more) polyphenols from both bergamot and cynara, as would be availed otherwise. Lastly, the bergamot pulp fibers establish the formulation as 100% excipient-FREE, appealing to clean-label formulations and uncomplicated production runs.

BergacynFF’s enhanced profile gives it a competitive edge in dosing over other common liver fat support actives and ingredients that support healthy metabolism. Many common hepatoprotective nutrients and botanicals oblige doses well over 1,000 mg per day, whereas Bergacyn®FF has been trialed and proven effective at only 600 mg per day.

Bergacyn®FF was trialed in 2 published, clinical studies. Study #1 evaluated Bergacyn®FF at 600 mg/day over 12 weeks in subjects with Metabolic Syndrome and increased baseline liver fat levels. Bergacyn®FF more effectively attenuated liver fat levels and body weight than placebo, even with imposed baseline BMI-assigned caloric restrictions in both groups.

The 2nd Clinical Study on Bergacyn®FF trialed the formulation in a Diabetic population with excessive liver fat accumulation and borderline endothelial dysfunction. This study also evaluated the synergism potential of the Bergacyn®FF formula over standalone bergamot or Cynara extracts of the same dose. Many other dysmetabolism secondary endpoints were also evaluated in this trial.

Bergacyn®FF is a registered trademark of H&AD srl, exclusively licensed to DolCas Biotech, LLC.

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Applications

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Free-flowing material
Formulation for softgels

Benefits

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Supports healthy liver fat levels
Supports healthy lipid levels
Supports weight loss/weight management
Supports vascular function
Promotes healthier metabolism

Composition

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Bergacyn®FF is a solvent-FREE extract of Bergamot citrus fruit and pulp fiber and wild-type Cynara cardunculus leaves. Organically-grown grades of Bergacyn®FF are also available.

Safety

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Bergacyn®FF is a safe and well-tolerated ingredient, evaluated for safety in animal models and within a human clinical trial. Bergacyn®FF has an LD50 > 5,000 mg/kg and showed no histopathological toxicity, over 90 days in an OECD-guided chronic rat model. Further, Bergacyn®FF was subject to mutagenicity and cytotoxicity study and showed no toxic effects. In the human clinical trial, evaluating 102 subjects for BergacynFF’s effects on lipid accumulation in the liver, BergacynFF’s intake in susceptible populations showed the lowest risk of worsening or not improving of liver fat accumulation progression, as compared to placebo. Further, the prevalence of adverse events were not any greater than those resulting from the placebo, all of which were of low incidence and of grade 1 quality.

Clinical Research

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Liver, Cardio-metabolic, and Weight Management Support

Bergacyn®FF has demonstrated highly efficacious results at only 600 mg/day. Two studies have been published on Bergacyn®FF effect in dysmetabolic subjects as well as in clinically diagnosed, Type 2 Diabetes, over 12 and 14 weeks respectively. Bergacyn®FF continues to be studied in ongoing clinical investigations. The below studies have already been published.

Musolino V, et al. The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease. May 2020; 10(2): 268-274
Farro Y, et al. Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years. Front.Endocrinol. August 2020

FAQ

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Our Products

TruOliv™ is a genuine olive fruit and leaf-sourced, waste-water and solvent FREE, USDA and EU organic, polyphenol-rich powder extract with clinically proven benefits.

MoriKol® is a clinically-proven, fast-acting, bioavailable marine collagen. A low dose supplys a minimum of 15% tripeptides for the convenient delivery of beauty from within bioactives.

MMP50™ is a New-Zealand sourced green lipped mussel extract, uniquely crafted, rich in Omega-3's and standardized for bioactivity in joint health using a MMP-inhibition assay.

Bergacyn®FF is a patented, clinically-proven Bergamot and Cynara leaf extract, supporting cardiovascular and metabolic health in populations having accumulated excess liver fat.

Truly ‘next GENeration’ Curcugen® is a clinically-studied, 39X-bioavailable, turmeric oleoresin-based curcumin extract with a food & beverage friendly dispersion and taste profile.

Fortiquin™ is a patent-pending standardized formulation of herbs and nutrients that are clinically proven to support male sexual stamina and overall well-being.

Ginfort® is a patented, highly stable, concentrated gingeroids (26%) active. The solvent-free extract has clinically-proven benefits in relieving symptoms of functional dyspepsia.

NitrateBurst™ is a patent pending, clinically-proven and water soluble Green Spinach extract, supporting healthy energy levels and nitrate production.

FAQ

Q: What is meant by next-GENeration curcumin®?

A: The ‘next-GENeration’ label is being given to Curcugen® because of its unique sourcing material and food-state matrix i.e.oleoresin, the novel technology used to extract high levels of curcuminoids from this starting material while maintaining a diverse spectrum of other turmeric constituents, and the versatility of its formulation across the dietary supplement, food and beverage industry. Further, this term obliges the highest of industry standards of substantiation, by taking up a comprehensive safety and clinical research program.

Q: What is Curcugen’s® composition?

A: Curcugen® is 98.5% turmeric-oleoresin derived, is standardized to 50% curcuminoids and contains both turmeric essential oils and ‘polar’ turmeric resins.Further, it contains 1.5% of a flow agent.

Q: What are ‘polar’ resins?

A: Turmeric oleoresins include resins that polar and non-polar in character. The Self-D™ technology is able to capture the polar resins, meaning those with an electrical charge. The benefit of the polar resins, which are novel to the Curcugen® brand, is that when they are complexed with curcuminoids, they attract water toward the molecule, overcoming curcumin’s natural hydrophobicity. In a fluid medium the matrix is activated allowing for a slow release function and a dispersing quality.

Q: How is Curcugen® different than turmeric oleoresin?

A: Curcugen® is an optimized turmeric oleoresin extract. Through the Self-D technology, the more ‘polar’ resins are retained, along with some essential oils; they are complexed with curcuminoids, which are enriched to a 50% standard. Turmeric oleoresin itself contains resins in their natural form, not optimized for bioavailability and curcuminoids in a much smaller concentration.

Q: How is Curcugen® different than 95% curcuminoids?

A: 95% curcuminoids are derived from turmeric oleoresin. 95% curcuminoids are a purified form of the oleoresin, whereby the essential oils and resins are lost during manufacturing. Again, Curcugen® retains both essential oils and the more ‘functional’ resins, while maintaining a significantly substantial concentration of curcuminoids, at a 50% standard.

Q: How many more times bioavailable is Curcugen® than unformulated curcumin?

A: Curcugen® is 39-times more bioavailable than unformulated/95%-curcuminoids, as demonstrated by a 18-subject cross-over designed study.

Q: What is the clinical dose for Curcugen®?

A: The clinical dose for Curcugen® is between 500-1000 mg per day.

Q: Is Curcugen® a clinically-studied ingredient?

A: Yes. Curcugen® is being evaluated clinically. A pharmacokinetics/bioavailability study and (3) clinical studies have already been initiated on the ingredient. See the ‘Clinical Research’ tab on Curcugen’s product page for additional information.

Q: Is Curcugen® safe?

A. Yes. Curcugen® has been proven to be safe according to OECD Safety testing. The acute toxicity study resulted in a LD50 > 5,000 mg/kg and the sub-chronic, repeat dose, 90-day toxicity study has confirmed safety in an animal model at > 2000 mg/kg/day. See the ‘Safety’ tab on Curcugen’s product page for additional information.

Q: Is Curcugen® GRAS?

A. Curcugen® has not been established as GRAS as of yet, however it is pending a self-affirmed GRAS determination at this time.

Q; Is Curcugen® dispersible in water?

A. Yes. Curcugen® is water-dispersible. However, it is not water-soluble.

FAQ

Q. What is the clinically studied dose of Bergacyn FF?

A. The clinical dose of Bergacyn FF is 600 mg per day. Bergacyn FF has been trialed as a single 600 mg dose once per day, and separately in divided doses of 300 mg twice per day. Both human clinical studies supported Bergacyn FF in its promotion of healthier liver fat levels.

Q. Should Bergacyn FF be taken with or without food?

A. In both clinical studies, Bergacyn FF was administered with food.

Q. That is the composition of Bergacyn FF?

A. Bergacyn FF is a micronized and co-grinded blend of the juice extract and pulp of Bergamot citrus fruits (Citrus bergamia), and the solvent-free extract of a wild-type of artichoke leaves (Cynara cardunculus, sylvestris)

Q. Is Bergacyn FF patented?

A. Bergacyn FF is patented for composition, manufacturing process and application in the therapeutic support of healthy liver fat levels.

Q. Is Bergacyn FF consistent from batch to batch?

A. Yes, Bergacyn FF is standardized by process to consistently result in no less than 17% bergamot polyphenols (inclusive of neo-hesperitdin, naringin, bruteridin, melitidin and neo-eriocitrin) and 5% cynaropicrin from artichoke leaf.

Q. Are solvents used in the production of Bergacyn FF?

A. Bergacyn is a completely solvent-free extract.

Q. Is Bergacyn FF a free-flowing ingredient?

A. The novel use of bergamot pulp fibers helps the material maintain a free flow during production runs and allows for the promotion as ‘excipient free’ when formulated alone or with other free-flowing materials.

Q. Would a combination of Bergamot extract and Artichoke extract afford the same benefit as Bergacyn FF?

A. Bergacyn FF undergoes a patented production process that includes the addition of bergamot fibers, and further consists of a method of co-grinding and micronization. A clinical study evidenced that the method of preparation activated synergistic value that is not available in the standalone extracts of either ingredient.

Q. What does the FF in Bergacyn stand for?

A. The ‘FF’ in Bergacyn FF stands for free-flowing, which is a novel benefit of the addition of bergamot albedo fibers.

Q. Does Bergacyn FF have support of safety studies?

A. Bergacyn FF has been subjected to 28-day and 90-day repeat-dose, toxicity studies and found not to exhibit any safety concerns or changes.

Q. What clinical findings prove Bergacyn FF claim of vascular support?

A. In the 16-week study of Bergacyn FF on fatty liver and vascular changes in Diabetic subjects, the Reactive Hyperemia Index (RHI) increased by >0.5 in the Bergacyn FF group where it went down in the placebo group. RHI is an index of vascular health, wherein an increase above 2 is strongly suggestive of cardiovascular protection.

Q. How much weight was lost in the Bergacyn FF group over the placebo group in the clinical study on Metabolic Syndrome in which overweight and obese subjects in both groups were subjected to a 400-500 calorie restriction?

A. The Bergacyn FF group lost 9.6 lbs., whereas the placebo group only lost 5.2 lbs. In the 12-week study, the diet, plus Bergacyn FF group lost nearly 2X the weight of the diet, plus placebo group.

Q. How does Bergacyn FF compare to other actives for liver health, like silymarin?

A. Bergacyn FF really has star potential at such a low dose. Many of the other studies done on other actives like silymarin, NAC, bergamot polyphenols as a standalone, vitamin E or even berberine require doses well over 1 gram/day and have not shown complementary liver fat support effects, including promotion of healthy weight, support of vascular health, etc. as has been proven with Bergacyn FF.

Q. Does Bergacyn FF offer any bioavailability enhancements that overcome absorption concerns known to polyphenol-based actives?

A.The addition of bergamot fibers has proven to enhance the bioavailability of Bergacyn FF polyphenols including naringin, chlorogenic acid and luteolin by an average of 2.5X.

Q. Does Bergacyn FF contain any bergamottin?

A.Bergacmottin is a furanocoumarin, with known CYP-450 inhibitory activity found in the pulp and peel of the bergamot fruit. Every batch of Bergacyn FF is tested for bergamottin and its levels are consistently found to be negligible.

FAQ

Q: Is MoriKol® tested for environmental contaminants?

A: Yes. MoriKol® is assayed for and complies with all regulated limits of detection for 40+ antibiotics, PCBs and heavy metals including mercury, lead, arsenic and cadmium.

Q: Is MoriKol® FMD and BSE-free?

A: Yes. MoriKol® is 100% FMD and BSE-free, but this is by default – as these diseases do not develop in marine/pescine sources, but can be the result of unscrupulous practices in the rearing of land animals, i.e cows. The majority of collagen on the market is bovine (cow) sourced, so this can still pose even small concerns, even when a product certifies themselves as ‘BSE and FMD-free’, because low-level, untraceble levels or the prions that causes these diseases may persist in the source material, and can still transfer to the human or animal that consumes them.

Q: What marine source is MoriKol® from?

A: MoriKol® is a clean-cultivation, Kosher sourced fish.

Q: What is the molecular weight distribution?

A: The molecular weight of MoriKol® is between 200-2000 Da, or < 1500 Da on average. The 15% tripeptide component of which average ~ 280 Da.

Q: Are there any allergens?

A: No. Our tests result show MoriKol® to be devoid of any Egg, Gluten, Peanut, Soybean, Milk, Almond, of Crustacean allergens.

Q: Don’t all collagen products have tripeptides?

A: Yes and No; most collagen products will have some very low molecular weight peptides, such as those in the low range under 300 Da – but the quantity thereof is quite negligible. Most hydrolyzed collagen products demonstrate a predictible bell curve, whereby the majority of peptides are in the middle of the bell curve, centered about the median peptide value. However, MoriKol’s® low molecular weight collagen peptides (LMWCP) show a much more skewed curve, with two peaks showing a significant portion of peptides in the tripeptide range. This is the minimum 15% standard that we promote. Conversely, tripeptides in most other collagen hydrosylates are in the low 0-1% range.

Q: What does the 15% tripeptide standard have to do with bioavailability?

A: Bi- and Tripeptides of collagen are the smallest absorbable peptide units. They have both been measured in the serum intact, either meaning that bipeptides have been predigested from tripeptides and absorbed, or that they too are absorbed directly from their available source material. MoriKol’s® LMWCP deliver a 15% concentration of tripeptides, whereby in other products this amount is not guaranteed, and moreover tend to be available in negligible quantities. Because bi- and tripeptides are absorbed intact (i.e. more bioavailable), and/or require minimal predigestion activities, their action is more direct and predictable. Bi and tripeptides directly serve as collagen repair buidling blocks, or through indirect action, stimulate fibrobrast recruitment and collagen deposition.

Q: What does bioavailability have to do with bioefficacy?

A. Because more tripeptides are predictably and directly delivered to the body (e.g. areas of collagen breakdown), the results of a 64-women DBPCR-trial has shown remarkable results at an industry-low dose of LMWCP of only 1g/day. Additionally, some of the beneficial results of these LMWCP showed significance as early as 6 weeks after intake. Most hydrolyzed collagen products show beneficial effects at higher doses, and often times after 12-weeks of intake.

Q: What is the importance of 1g/day dose?

A: Being able to supply a clinically-proven dose of collagen at 1g/day is completely novel. The molecular weight of a product has a lot to do with the amount of bulk/room it occupies. Larger molecular weight collagen hydrolysate products, therefore traditionally required high doses. As hydrolysates have gotten smaller and smaller over time, the required doses to obtain clinical value has also come down, yet none have come down as low as MoriKol®.

For this reason, nearly all collagen products on the market are sold in tubs, or containers with free flowing powder and scoop/tablespoon sizes are required per day. Generally holding about 500 mg, encapsulated collagen products are definitely available on the market, they tend not to sell as well as powders – as the requirement is often times 6-10, or even 20 capsules per day. Capsules are supposed to a convenient delivery system, but this is definitely NOT convenient! MoriKol’s® full dose can be obtained in ONLY (2) capsules/d.

FAQ

Q: What makes TruOliv a ‘full spectrum’ extract?

A: TruOliv™ utilizes the whole olive fruit and leaf and does not process them under any chemical or synthetic reactions. Because many of olive’s polyphenols are very similar in chemical structure, the use of imposed chemical reactions can discriminately concentrate levels of interest polyphenols, while sacrificing others found in a more natural spectrum. Extra-virgin olive oil (EVOO) is prepared from table olives by a purely physical process. Approximately, 36 polyphenols have been identified in olive oil as a result.

Four-generations of olive expertise informs a patent-pending prescription for producing TruOliv™, which includes the chronology of olive and leaf harvesting, their ratios and concentrations, which actualizes the ‘full spectrum’ dynamism of TruOliv™. Our testing confirms the presence of nearly 1/3rd* of all the polyphenols that are known to exist in EVOO.

*Note: TruOliv™ shows measurable levels of all polyphenols that are available in the testing panel.

Q: What are the benefits of using the leaf and fruit vs. waste water or only fruit or only leaf?

A: Olive waste water is a natural byproduct of olive oil production. Previous to the oil separation phase, olives undergo crushing and mixing with water. Because many of the polyphenols are hydrophilic, many of them remain in the water. However, as olive oil is produced from mature olives, which have autogenously (within the olive) converted the majority of native oleuropein, characteristic of the immature fruit – the waste water reflects this same profile: high levels of hydroxytyrosol, with little to no oleoropein.

The commercial products of waste water extract, also generally undergo a solvent-extraction step to further purify and concentrate HT. Using the leaf and whole olive fruit, allows for a characteristic blend of polyphenols that are synergistic, and further the solvent-FREE process avails these polyphenols in a chemical-free, organically-certified format.

Q: What is unique about TruOliv’s growing conditions?

A: TruOliv™ olives and leaves are grown in the Saharan desert of Northern Africa (Morocco). The olives and leaves grown in these conditions endure extreme stress and as a result, natuarally produce olives with higher polyphenols concentrations. Polyphenols are secondary metabolites of plants, and while they are useful adjuncts to the human diet, they are crucial components to a plant’s survival.

Desert conditions are extreme conditions, to which only the most resilient of plants can survive. Studies investigating this phenomenon have helped to uncovers some of the involved mechanisms, including the activation of phenalylanine lyase, a polyphenol production catalyst using simulated desert conditions, such as Regulated Deficit Irrigation practices.

Q: Is the product standardized?

A: YES. Although the TruOliv™ does not undergo solvent or hydrolysis reactions and is 100% pure olive fruit and leaf derived it is not a simple powder of these dried materials. The use of physical extraction techniques and desert enrichment results in an extract that is 10% Total Polyphenols, 6% Oleuropein, and 2% Hydroxytyrosol.

Q: What makes the product more bioavailable?

A: Because the product is made using the whole fruit, there are trace amounts of olive oil incorporated in the product. Independently done bioavailability studies on olive polyphenols, i.e. hydroxytyrosol show that HT is more bioavailable in a lipid medium, than when found in a purely aqueous medium.

Q: Why not just consume olives/olive oil?

A: You would have to consume 20+ tablespoons of olive oil (approximately 1.25 cups), which would result in over 3,000 calories just from fat (nearly 2 days worth of food), to receive just the Hydroxytyrosol quantity found in a suggested daily dose of TruOliv™. This quantity does not additionally take into consideration other synergist polyphenols.