Clinical Evidence

Lipid-modifying effects of adjunctive therapy with curcuminoids–Piperine combination in patients with metabolic syndrome: Results of a randomized controlled trial
Complement Ther Med. 2014; 22(5):851-57
Metabolic syndrome (Met S) is a serious health problem affecting millions around the world today in both developed and underdeveloped countries, one third of the US population is suffering from Met S. It is diagnosed as simultaneous occurrence of several risk factors such as hypertension, hyperglycemia, abdominal obesity and atherogenic dyslipidemia.

Atherogenic dyslipidemia, one of the main features of Met S has been associated with increase in plasma triglyceride levels and low HDL-C levels. The key to management of Met S is controlling individual risk factors and the most prominent and modifiable factor is dyslipidemia. Since there are cluster of risk factors working in tandem, benefits of drugs such as statins used for the management of dyslipidemia are limited.

In some published experimental and clinical studies, Met S patients have been shown to have over production of (ROS), diminution in antioxidant enzymes and increase in lipid peroxidation and protein oxidation biomarkers. Hence, there is a need to find safe and effective products for the management of risk factors of Met S. Curcumin being versatile in its activity against inflammation, oxidative stress, hypertension and hyperglycemia can be a useful tool in the management of Met S and also in conditions such as insulin resistance, which is a core factor in development of Met S.

To investigate the effects of bioavailability-enhanced Curcuminoids in patients with metabolic syndrome on serum lipid concentration, as an adjunctive to standard of care.

Study Design:

In this randomized, double-blind, placebo-controlled, parallel-group clinical study benefits of curcumin’s lipid modifying activity was evaluated in 100 patients with Met S (according to NCEP-ATPIII criteria). Patients were randomized either to receive Curcuminoids-Piperine combination (1000 mg-10 mg/day) or matching placebo for 8 weeks. The subjects included in the clinical trial fulfilled the following diagnostic criteria as summarized the below table.

All subjects were already receiving standard of care and were on lipid-lowering, antihypertensive and oral hypoglycaemic agents along with life-style (physical activity, weight loss and no smoking and alcohol) and dietary (heart-healthy diet) modifications.

Blood samples (overnight fasting) were collected from each subject at baseline and at the end of the trial, and were analyzed for complete lipid profile (i.e. total cholesterol, LDL-C, HDL-C, triglycerides, sdLDL and lipoprotein(a) levels).

The parameters evaluated during the trial (i.e. at baseline and at the end of the study) included fasting glucose level and lipid profile (total cholesterol, LDL-C, HDL-C and Triglycerides) along with liver and kidney function tests.

  • One hundred subjects (n=50; Curcuminoids-piperine combination and n=50; placebo) completed the study
  • A significant reduction in LDL-C, non-HDL-C, total cholesterol, triglycerides and Lp(a), elevation in HDL-C was observed in Curcuminoids-piperine combination group
  • The use of Curcuminoids-Piperine combination was found to be safe and very well tolerated in the patients

The authors concluded that Curcuminoids were effective adjuvant therapy, which lead to improved serum lipid concentrations in Met S patients.

This was the first clinical study to evaluate the safety and efficacy of Curcuminoids-piperine combination as adjunctive therapy in treating elevated serium lipid profile in Met S patients. Hence, these findings encouraged the use of bioavailability enhanced Curcuminoids as a part of Met S treatment regimen.