John Colman, PhD Clinical Pharmacology's Post

29 Apr.,2024

 

John Colman, PhD Clinical Pharmacology's Post

FSSAI's mock war on nutraceuticals begins Recently this news has been published in the newspapers that the meeting of the Scientific Committee formed by FSSAI has started, in which the meetings are going on to determine the new guidelines regarding nutraceuticals. New guidelines will be given to regulate the nutraceuticals industry or efforts are being made to make these industries self-sustaining. This will be known only after the guidelines are made public. FSSAI is busy in organizing events anyway. But the point worth noting is that by getting it written by doctors in the name of nutraceuticals, nutraceutical companies are making huge profits. Generally, tablets or capsules of any such nutraceuticals are intentionally packed in such a way that it looks like essential medicine. By adding any food supplement element to the classic Ayurveda formulas of Ayurvedic medicines, new food products are available for sale in the market. And also recognized by FSSAI. Whose prices are more than the main medicines for treatment. The nutraceuticals market has almost doubled since the Corona period. According to the market, the market of $ 4-5 billion in India will increase three times by 2025, that is, it will reach 15 to 18 billion dollars. The reason for this is the marketing and excessive advertisement of the nutraceutical company among the doctors. In such a situation, the ongoing meeting of the committee formed by the scientists of the Nutraceuticals Department of FSSAI seems like informality. While the guidelines have been made and will be made according to the big producers of the nutraceuticals industry. The common man is already troubled by inflation. On which the addition of additional food ingredients in the treatment should be a matter of concern for FSSAI. The same excessive food supplement or nutraceutical products can also be fatal. There are research reports from many developed countries around the world. Foodman has told through his earlier articles (Illusion of Vitamins, Anti Nutrients) that excessive or unnecessary use of food supplements or vitamins can be fatal. #marketing #india #food #events #medicine #newspapers #fssaiindia #ngos

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Research Breakdown on Berberine

In diabetic rats given a high fat diet, oral intake of 50-200mg/kg Berberine daily reduced the kidney:body weight ratio and improved the histological observation at 100-200mg/kg intake (50mg/kg did not seem too effective) with the increase of type IV collagen and TGF-β1 seen in diabetic rats being prevented with all dose of Berberine; protective efficacy of 100-200mg/kg seemed comparable to Enalapril (1mg/kg) and Simvastatin (2mg/kg) used as active controls;[265] this study is replicated in Medline.[266] Protective effects from a high fat diet on renal damage in diabetic mice has been noted elsewhere with 100-200mg/kg Berberine over 8 weeks, with similar protective effects as 250mg/kg Metformin[267] and other studies have noted that reduces fibronectin[268] or matrix accumulation in general[269][270] following oral treatment.

The increase of TGF-β1 (as well as fibronectin) in the kidneys is mediated by high blood glucose, and precedes diabetic nephropathy[271] and its use as a biomarker for disease progression has been suggested.[272] The inhibition of both TGF-β1 and Fibronectin have been observed from glucose-induced induction of these proteins, with 30uM of Berberine being effective nad 90uM being either equally effective or moreso than the reference drug N,N-dimethylsphingosine (known inhibitor of SPK1).[273] Sphingosine Kinase 1 (SPK1) is a rate limiting enzyme that catalyzes Sphingosine to sphingosine 1-phosphate (S1P)[274] and is activated to a high degree in diabetic kidneys.[275] Berberine has been implicated in suppressing the activity of the SPK1 enzyme in vivo in diabetic mice at 300mg/kg daily for 12 weeks[276] and although it has potent inhibitor effects on SPK1 induction from glucose it does not appear to directly interact with the enzyme.[273] and may be secondary to AP-1 inhibition.[273]

Other possible mechanisms of protection to the kidneys that do not appear to be mediated by anti-inflammatory mechanisms (AP-1 and NF-kB inhibition are generally called antiinflammatory) are anti-oxidative and aldose reductase inhibitory potential;[277] this study being replicated in Medline.[278] The induction of the Aldose reductase receptor that occurs during diabetes appears to not occur if treated with 200mg/kg Berberine throughout the diabetic period.[278] Anti-oxidant effects also seem apparent due to normalization of superoxide dismutase (SOD) and MDA (indicator of lipid peroxidation),[278] and in isolated rat kidney homogenates the anti-oxidative effects (against ferrous-ascorbate lipid peroxidation) of Berberine are slightly more than the reference compound butylated hydroxytoluene.[279]

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These protective effects may extent to non-diabetic kidneys, as evidence by a study in diet-induced hypertensive rats that recieved renal protection.[280]

Berberine appears to be effective in disconnecting the adverse effects of high blood glucose on the kidneys, and is most well studied in preventing the fibrotic progression of diabetic nephropathy; this appears to be related to anti-inflammatory mechanisms of action

Berberine has been implicated as having antiurolithic effects (reducing kidney stones),[279] due to one of the herbs it is derived from ( Berberis Vulgaris) being used traditionally for this purpose.[281] Berberine was found to have slight diuretic effects between the oral doses of 5-20mg/kg (up to 78%) while increasing urinary sodium and potassium but reducing calcium (similar to hydrochlorothiazide).[279]

Oral ingestion of 500mg Berberine thrice a day (1500mg total) for 12 weeks in otherwise healthy humans has failed to note any renal toxicity associated with supplementation.[126]

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