Additional results also found the nutraceutical’s apparent efficacy in reducing total cholesterol, triglycerides, and low-density lipoprotein cholesterol, also known as LDL or ‘bad’ cholesterol.
“Further studies are necessary to see if our results could be applied to these groups of patients, even if nutraceuticals should not be considered a replacement of pharmacological therapy,” the team said, led by Dr Giuseppe Derosa, researcher based at the University of Pavia in Italy.
“Nutraceuticals can help in delaying pharmacological treatment in patients at low cardiovascular risk, or, in addition to pharmacological treatments, they can help in reaching an adequate lipid profile in patients not tolerating high dose of statins.
“We also have to consider the cost-effectiveness of nutraceutical therapy; in this case the cost is about €0.50 per day.”
The team’s findings mirror those outlined by the European Food and Safety Authority (EFSA), which recognise a cause and effect relationship between monacolin K consumption from red yeast rice and maintenance of normal blood low-density lipoprotein cholesterol (LDL-C) concentrations.
In addition, the expanding market of functional foods containing plant sterols and stanols has focused interest on their cholesterol-lowering effects.
Previous work has demonstrated an intake of 2 grams per day (g/day) of plant sterols and stanols reduces serum LDL-C concentrations by approximately 10%.
Curcumin has also shown promise in the prevention and/or management of some conditions that are attributed to its anti-oxidant, anti-inflammatory activities rounded off by an excellent safety profile.
The consumption of olive polyphenols as part of a regimen such as the Mediterranean diet could help explain the reduced risk of metabolic disease.
The double-blind, placebo controlled study enrolled 80 Caucasian patients, aged over 18 of either sex, at low cardiovascular risk but were deemed overweight (BMI 25.0–29.9 kg/m2).
Patients received a soft gelatine capsule (Colesia, made by IBSA Pharaceuticals) that contained 166 milligrams (mg) of red yeast rice (containing 3% of monacolin K and a citrinin content lower than 0.05 parts per million (ppm).
The capsule also contained 720 mg of plant sterol esters; 250 mg of Curcuma longaL., rhizome extract, with a total curcuminoid content of 18% and 25 mg of olive (Olea europaea L.) fruit extract, with a total hydroxytyrosol and tyrosol content of 10%.
Placebo soft gelatine capsules were prepared using a mixture of medium-chain triglycerides as the only ingredient. Both treatments, taken once a day for at least 100 days.
After enrolment, all patients entered a one month run-in period where they followed a controlled-energy diet (near 600 Kcal daily deficit). Patients were not treated with vitamins or mineral preparations during the study.
All patients underwent an initial screening assessment that included a medical history, physical examination at baseline and after 3 months.
At the baseline and at the end of the study all patients underwent an oral fat load.
Results found that the nutraceutical combination gave a reduction of total cholesterol, triglycerides, and LDL cholesterol when compared to baseline and to placebo.
The team also found that the parameters recorded during oral fat load improved compared to the oral fat load performed at baseline with the nutraceutical combination.
Nutraceuticals and lifestyle changes
“The pronounced reduction in the plasma levels of LDL-C, and triglerides is probably due to the synergic action of fermented red rice titled at 3% in monacolin K and sterol esters contained in the nutraceutical mixture,” the team suggested.
“We [also] recorded the use of nutraceutical combination reduced the peaks of endothelial markers compared to baseline, and to placebo, where no changes between oral fat load (OFL) performed at baseline and at the end of the study were recorded.
“We think that the effect of nutraceutical combination on the OFL-dependent release of the different adhesion molecules analysed can be explained by the improvement of lipid profile, and to the reduced endothelial damage.”
“Of course, nutraceuticals should be combined with adequate lifestyle changes.”
The researchers cited the relatively short duration of the study suggesting a longer follow-up in order to see if the effects observed in three months would be maintained on the long term.
Patient testing could also be extended to those on a statin therapy in primary and secondary prevention as well as patients with statin intolerance in primary and secondary prevention.
Published online ahead of print: doi.org/10.1016/j.phymed.2018.01.014
“Effects on oral fat load of a nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols: A randomized, placebo controlled trial.”
Authors: Giuseppe Derosa et al.