The Study List

CLINICAL STUDIES

Influence of piperine on the pharmacokinetics of curcumin in animals and human volunteers.

Curcumin C3 Complex® + BioPerine® (2000 mg + 20 mg/day). Piperine enhances the serum concentration and bioavailability of curcumin in both rats and human. Relative bioavailability of curcumin when combined with BioPerine® is 2000%.

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Turmeric extract - Curcumin C3 Complex®

Turmeric extract (Curcumin C3 Complex®) is prepared from the dried rhizomes of turmeric (Curcuma longa) and contains a minimum of 95% curcuminoids. The name Curcumin C3 Complex has reference to its three main compounds – Curcumin, demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC).

Traditional knowledge with modern benefits

Turmeric is one of the oldest, most revered, and widely used medicinal plants in the world. It is infused in various health care systems and traditional practices with the aim to acquire overall wellbeing. Turmeric is extensively used in Ayurveda, the 5,000 year-old natural healing system of India, in managing several conditions, including those of the skin, pulmonary, and gastrointestinal systems, aches, pains, wounds, sprains, liver disorders, joint pain, and inflammation. All the health benefits of turmeric are attributed to curcuminoids, a constituent group of phytochemicals with characteristic yellow color (Betül Kocaadam and Nevin Şanlier, 2017).

Sabinsa’s turmeric is cultivated in controlled-contract farmlands with good agricultural practices. It is manufactured in FDA inspected, and USP-GMP and FSSC 22000:2005 certified facilities. The product is stringently tested to be free from pesticides, over one hundred of them. Every batch shall be analyzed for the naturalness through radiocarbon testing (https://www.nutritionaloutlook.com/herbs-botanicals/nutritional-outlooks-2016-best-industry-ingredient-supplierservice-provider-sabinsa-corp). Thus, it has enjoyed the confidence with customers over three decades in terms of quality and performance. While, in terms of dosage forms sold, Curcumin C3 Complex has sold in hundreds of millions of doses. It also has the TRU-ID certified certification (http://www.tru-id.net/certification/), Non-GMO Project Verified (https://sabinsa.com/nongmo) and received no objection letter from U.S FDA for Curcumin C3 Complex on its GRAS status. Honored with several merit awards such as Scientific Achievement Award by NBJ (2007), Product Merit Award by NBJ (2008), Functional Ingredients Editor’s Choice Award in the Marketing Category by Functional Ingredients (2012) and Winner of NutraIngredients-USA Award (2016). Sabinsa boasts that it provides the pharmacopeial standards of curcuminoids to US Pharmacopeia. The product has undergone thorough scientific scrutiny which is dictated by the fact that more than 150 research papers including 79 clinical studies have been published. All these making it an international award-winning ingredient as the most clinically studied Curcumin brand available today.

Turmeric extract

Golden spice – Golden metabolites

The “Yellow Curry Powder”, Turmeric, is one of the most valued spices dating back thousands of years for its food, medicinal, and even cosmetic uses. The most potent bioactive present in turmeric is curcumin, a pronutrient, i.e., it is converted into several active forms during metabolism when taken orally. Studies revealed that curcumin will get converted into phase I and Phase II metabolites within 3 hours after oral intake and it is the phase I metabolites (dihydro-, tetrahydro-, hexahydro- and octahydro-curcumin) that exhibit potent biological activity than the phase II metabolites (Vareed et al., 2008. Cancer Epidemiol Biomarkers Prev. 2008 June; 17(6):1411–1417). The curcuminoids have shown a multitude of pharmacological activities that are beneficial in improving human health and combat against various illness condition. They have been shown to maintain healthy blood glucose levels, normal lipid profile, support gut health, reduce oxidative stress, and resolve healthy inflammation responses.

Milestones – Curcumin C3 Complex®

1996: EP0839037 - Bioprotectant composition, method of use and extraction process of curcuminoids
1997: US 5861415 – Bioprotectant composition, method of use and extraction process of curcuminoids
2007: Sabinsa supported the United States Pharmacopeial (USP) Convention in preparing the monographs on curcuminoids and turmeric, and in developing in their validated analytical methods
2007: Scientific Achievement Award by NBJ
2008: Product Merit Award by NBJ
2009: Curcumin C3 Complex received self-affirmed GRAS status after a comprehensive review of safety and toxicology data by an independent panel of scientists of international reputed panel
2012: Functional Ingredients Editor’s Choice Award in the Marketing Category by Functional Ingredients
2013: Sabinsa has been issued a “No-comment” letter for Curcumin C3 Complex’s GRAS status from U.S. Food and Drug Administration
2015: Curry Powder to Clinical Significance, the 3rd book to be published on the scientific merits of Curcumin C3 Complex
2016: Winner of NutraIngredients-USA University Research of the Year Award
2020: Non-GMO Project Verified

Safety

The dietary intake of turmeric is considered safe since is one of the components of culinary preparations. Higher doses of curcuminoids are safe and easily tolerated by the human subjects even at a dose 12g per day in the cancer subjects. Also, product eminence is explicated by the fact that more than 21 nutraceutical/pharmaceutical companies are using Sabinsa’s Curcumin C3 complex, as one of the ingredients in their curcumin containing products.

Short-term curcuminoid supplementation for chronic pulmonary complications due to sulfur mustard intoxication: Positive results of a randomized double-blind placebo-controlled trial

 

   Drug Res (Stuttg).  2015; 65 (11): 567-73. DOI: 10.1055/s-0034-1389986.

 

Pulmonary problems are one of the most frequent chronic complications of sulfur mustard intoxication and are often accompanied by deregulated production of pro-inflammatory cytokines. Curcuminoids are phytochemicals which possess remarkable anti-inflammatory properties. Thus, the present study investigated the effects of curcuminoids supplementation in chronic pulmonary diseases.

 

Objective:

To evaluate the clinical effects of curcuminoids supplementation on markers of pulmonary function and systemic inflammation in sulfur mustard intoxicated subjects.

 

Method:

This was a randomized double-blind placebo-controlled study, conducted with 89 male subjects who were suffering from chronic sulfur mustard induced pulmonary complications. The subjects were allocated to receive either 1500 mg of curcuminoids per day or placebo for 4 weeks.

 

Results:

  • Curcuminoid supplements showed a greater effect of improving pulmonary function, FEV1/FVC (p=0.002) and inflammatory mediators including IL-6 (p<0.001), IL-8 (p=0.035), TNFα (p<0.001), TGFβ (p<0.001), substance P (p=0.016), hs-CRP (p<0.001), CGRP (p<0.001) and MCP-1 (p<0.001) compared to placebo.

 

Conclusion:

Short-term adjunctive therapy with curcuminoids can suppress systemic inflammation in patients suffering from sulfur mustard induced chronic pulmonary complications.

Enhanced systemic bioavailability of curcumin through transmucosal administration of a novel microgranular formulation

 

Anticancer Res. 2015;35(12):6411–6418. PMID: 26637850

 

Head and neck cancer is the cancer of the head and neck portion of the body and is developed through a multi-step process of genetic, epigenetic, and metabolic changes resulting from carcinogen exposure. Curcumin is a promising nutraceutical for chemoprevention of head and neck squamous cell carcinoma (HNSCC). However, the bioavailability of the capsular formulations of curcumin is one of the limiting factors for its proper application in the treatment of the same. Various formulations have been developed aiming to improve the systemic bioavailability of the curcumin. The microgranular curcumin is one such formulation devised to improve the curcumin bioavailability.

 

Objective:

To determine the bioavailability, efficacy, and safety of microgranular curcumin formulation, with transmucosal absorption property, in cancer subjects and healthy volunteers.

 

Methods:

The study was carried out in 8 healthy volunteers and 15 head and neck squamous cell carcinoma patients. The curcumin formulation consists of curcumin C3 Complex in the form of small beadlets (microgranules), manufactured by Sabinsa. Following the standard diagnostic incisional biopsy, patients were self-administered C3 Complex microgranules (4 g) and were instructed to hold it in the mouth for 10 minutes. Serum was collected at 15 min, 30 min, 1 h, 2 h, and 4 h after administration. The final serum collection occurred between days 21-28 after patients completed a 3-4 week regimen of 4 g twice-daily dosing of curcumin. Serum levels of curcumin were measured by HPLC. The biological activity of curcumin was assessed with Multiplex Immunoassay and immunohistochemistry.

 

Results:

  • Higher serum levels of curcumin were observed compared to other trials using capsular formulation
  • In cancer patients, a significant decrease in expression of fibroblast growth factor-2 (FGF-2) in post-biopsy samples and decreased serum levels of FGF-2, granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-17 (IL-17) (p<0.05) were observed

 

Conclusion:

Transmucosal administration of microgranular curcumin leads to enhanced curcumin bioavailability, which is associated with significant biological effects.

The synergistic effects of nano-curcumin and coenzyme Q10 supplementation in migraine prophylaxis: A randomized, placebo-controlled, double-blind trial

 

Nutr Neurosci. 2019. DOI:10.1080/1028415X.2019.1627770

 

Migraine is a disabling neurovascular disorder characterized by increasing pro-inflammatory cytokines levels and oxidative stress biomarkers. The combine curcumin and coenzyme Q10 (CoQ10) can exert neuroprotective effects through the modulation of inflammation and oxidative stress.

 

Objective:

To evaluate the combined effects of nano-curcumin and CoQ10 supplementation on migraine symptoms and quality of life in migraine patients.

 

Method:

The study was a double-blind placebo-controlled trial conducted with 100 episodic migraine subjects. The subjects were divided into four groups: (1) combination of nano-curcumin (80 mg) + CoQ10 (300 mg), (2) nano-curcumin (80 mg), (3) CoQ10 (300 mg) and (4) control for 8 weeks. Frequency, severity, duration of headache attacks, headache diary results and headache disability were assessed based on migraine-specific questionnaires at the baseline and end of the study.

 

Results:

  • The combination of nano-curcumin and CoQ10 supplementation group were showed a significant beneficial effect on the frequency, severity, duration of migraine attacks and headache diary results compared to other groups, also had better scores in migraine-specific questionnaires (p<0.001). There were no side effects reported by the participants.

 

Conclusion:

A possible synergistic effect of nano-curcumin and CoQ10 on clinical features of migraine.

About Sabinsa

Sabinsa Corporation is a manufacturer, supplier and marketer of herbal extracts, cosmeceuticals, minerals, dietary supplements and specialty fine chemicals for the nutritional, cosmetic, pharmaceutical and food industries.

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Headquarters

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Sabinsa Corporation
20 Lake Drive
East Windsor
NJ 08520, USA

Tel: +1.732.777.1111
Fax: +1.732.777.1443
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Headquarters

Sabinsa Corporation
20 Lake Drive
East Windsor
NJ 08520, USA

Tel: +1.732.777.1111
Fax: +1.732.777.1443
This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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