Clinical Trials

Results:

At the end of the study, compared with placebo, the Lipovor Active treated patients showed significant improvements in the following parameters: total fat mass (–3.1 vs –0.5 kg), total muscle mass (+2.1 vs +0.2 kg), total cholesterol (–1.2 vs +0.1 mmol/L), LDL-C (–1.1 vs –0.2 mmol/L), HDL-C (+0.2 vs +0.01 mmol/L), triglycerides (–0.3 vs 0.0 mmol/L), apoA1 (–0.2 vs 0.0 g/L), and apoB (–0.3 vs–0.1 g/L). Wessely and Powell scores decreased significantly by 40% (physical fatigue) and 45% (mental fatigue) in subjects taking Lipovor Active, compared with 11% and 8%, respectively, in the placebo group (p < 0.001 vs placebo for both parameters). No adverse events were reported in any treatment group.

Method used:

This was a placebo-controlled, randomised, double-blind, two-phase study.

Number of Subjects:

Eighty-four subjects were randomly assigned to two groups (matched for male/female ratio, age and body mass index).

Monitored Diet:

Prior to randomisation all patients entered a 2-week normalisation phase where they were given an ‘ad libitum’ diet, according to the National Cholesterol Education Program (Step 2). Subjects were asked to record their daily food intake every 2 days. Before the 30-day treatment phase, subjects were randomly assigned to two groups (matched for male/female ratio, age and body mass index).

Dosage:

One group received Lipovor Active twice daily (n =42) and the other placebo (n = 42) for 30 days.

Efficacy mesures:

Included changes in total fat mass, total muscle mass, serum triglyceride, total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C),apolipoprotein (apo)A1, and apoB levels. The Wessely and Powell scale was used to evaluate physical and mental fatigue. Subjects were assessed at the beginning and end of the study period.

* (Research Authors: Pistone, Marino, Leotta, Dell'Arte, Finocchario & Malaguarnera. Financial Sponsor: University of Catania, Italy)