Gnosis S.p.A. (Desio, Italy) has announced new study results on its Quatrefolic ingredient, a folate derivative of (6S)-5-methyltetrahydrofolate and vegetarian glucosamine salt, that suggest the ingredient may help reduce homocysteine serum levels in subjects with hypertensive risk. Quatrefolic—when combined with vitamin B12, vitamin B6, vitamin B2, zinc, and betaine—was found to significantly lower homocysteine serum levels compared to a control supplement.
Researchers in Italy studied 104 patients with a mean age of 62.8 +/- 14.5 years who had hypertension risk without a history of cardiovascular disease or cerebrovascular disease. Previous studies have linked high homocysteine concentrations to increased risk of cardiovascular disease, especially in elderly people, Gnosis notes. In this new study, participant hypertension risk was determined based on stage-1 essential hypertension and hyperhomocysteinemia, defined as homocysteine levels greater than or equal to 15 μmol/L.
For two months, participants were sequentially randomized to consume either a 5 mg/day folic acid supplement as control, or a finished-product supplement containing 400 μg of Quatrefolic, 3 mg of vitamin B6, 5 μg of vitamin B12, 2.4 mg of vitamin B2, 12.5 mg of zinc, and 250 mg of betaine once per day. The supplement containing Quatrefolic and B vitamins was Normocis 400, a commercially available supplement from Inpha Dumila Srl (Lecco, Italy).
Researchers found that both treatment groups experienced significant reductions to homocysteine levels at the end of the trial compared to baseline, with the Normocis 400 group presenting homocysteine levels of 10.0 +/- 1.7 μmol/L at the end of the study, versus 21.5 +/- 8.7 μmol/L at baseline. The experimental group’s reduction was also significantly higher than the control group, which had homocysteine levels declining from 22.6 +/- 6.2 μmol/L at baseline to just 14.3 +/- 2.8 μmol/L at the end of the trial.
What’s more, in 55.8% of participants taking Normocis 400, homocysteine levels fell to within the ideal range, defined as less than 10 μmol/L, researchers noted. No side effects were observed in either group.
“Randomized clinical trials are ongoing to test the effect of folate, B6, and B12 supplementation in primary prevention of cardiovascular and cerebrovascular events,” researchers concluded. “In the meantime, especially when the ideal [homocysteine] level is far from being reached, Normocis 400 appears to be safe, well tolerated, and effective in reducing [homocysteine] levels.”
Nutritional Outlook Magazine
Mazza A et al., “Nutraceutical approaches to homocysteine lowering in hypertensive subjects at low cardiovascular risk: a multicenter, randomized clinical trial,” Journal of Biological Regulators & Homeostatic Agents, vol. 30, no. 3 (July–September 2016): 921–927