Study supports Quatrefolic’s homocysteine reduction potential for hypertensives

By Adi Menayang

- Last updated on GMT

Photo: iStock/Brian A. Jackson
Photo: iStock/Brian A. Jackson
Italian researchers looked at how a “biologically active form of folate” can reduce high-levels of homocysteine, which may lead to cardiovascular risk, among hypertensive populations.

High-levels of homocysteine, the common amino acid in blood, are linked to heart disease. A study published in the triannual Journal of Biological Regulators & Homeostatic Agents​ investigated the efficacy of Quatrefolic, branded glucosamine salt of (6S)-5-methyltetrahydrofolate by Italian company Gnosis​, in lowering the homocysteine serum.

“Homocysteinemia ​[high levels of homocysteine] may be caused by several nutritional deficiencies other than B12, including vitamin B6 and folate deficiencies,”​ Gnosis said in a statement. “Decreasing plasma total homocysteine by providing nutritional cofactors for its metabolism has been shown to reduce the risk of cardiovascular events.”

Study design

The study had 104 male patients, mean age 62.8 years, 63% of which are males. Participants were recruited if they had stage 1 essential hypertension and hyper-homocysteinemia without a history of cardiovascular and cerebrovascular disease.

Participants were randomized and divided into two groups with 52 patients each—one supplemented with a combined nutraceutical containing 400 micrograms of folate-6-5-methyltetrahydrofolate (Quatrefolic), 3 mg vitamin B6, 5 micrograms of vitamin B12, 2.4 mg vitamin B2, 12.5 mg zinc and 250 mg betaine (Normocis400) once daily for two months, while the control group was supplemented with highly dosed folic acid (5 mg/day).

Results

Using an analysis of variance, the researchers found a significant reduction in homocysteine compared to the baseline in both groups at the end of the study treatment, but the Quatrefolic group’s reduction was significantly higher than the control.

“Homocysteine reduction was significantly higher among patients treated with the [nutraceutical blend] (p less than 0.035). The ideal homocysteine level (i.e. less than 10 μmol/L) was reached in 55.8% of cases in the [nutraceutical blend] group, and it was significantly higher than in controls,”​ the researchers wrote.

Gnosis markets its Quatrefolic product as a “biologically active form of folate,” ​a water-soluble B vitamin populary taken to prevent and treat low blood levels of folate. Earlier this year, the company released a flowchart​ about folic acid supplementation amid consumer concern that they are taking higher levels in it through fortified food products.

“The understanding of the folate world by physicians, end-users and producers of dietary supplements is one of our first target, to provide a tangible benefit for consumers,” ​Lorena Carboni, Product Support Specialist at Gnosis S.p.A.​, told NutraIngredients-USA.

Source: Journal of Biological Regulators & Homeostatic Agents

Published in Print, 2016 Jul-Sep;30(3):921-927

Nutraceutical approaches to homocysteine lowering in hypertensive subjects at low cardiovascular risk: a multicenter, randomized clinical trial

Authors: Mazza A., Cicero A.F., Ramazzina E., Lenti S., Schiavon L., Casiglia E., Gussoni G.

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