RESUMO
Purpose: The study aimed to investigate the efficacy and safety of SophorOx® (LN-OS-22) on oxidative stress and body composition in adults with excessive body weight and obesity. Participants and Methods: The 56-days randomized, double-blind, placebo-controlled, parallel-group, multi-centric clinical trial had individuals aged 30-60 years with body mass index (BMI) ≥25 to ≤34.9 kg/m2. 68 participants were randomly allocated to LN-OS-22 or placebo groups. The primary outcome was improvement in the oxidative stress. Secondary outcomes were changes in plasma lipopolysaccharide (LPS) and serum malondialdehyde (MDA) levels, weight and waist circumference, inflammatory markers, and quality of life. Results: At day 56, a statistically significant change in the 8-Isoprostane levels between LN-OS-22 vs placebo was observed (p = 0.0222). As compared to placebo, at the end of study, statistically significant reductions were demonstrated in body weight, waist circumference and BMI in the LN-OS-22 group (p < 0.0001). Also, a statistically significant change when compared to placebo for the energy/stamina domain (p = 0.0300) of the Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) questionnaire was depicted in LN-OS-22 group. Conclusion: The study demonstrates that LN-OS-22 was effective in reducing the oxidative stress, anthropometrics and improving the quality of life in individuals with overweight and obesity.
RESUMO
CONTEXT: Preliminary studies have suggested that both citrus flavonoids and palm tocotrienols reduce cholesterol levels in laboratory animals. OBJECTIVE: To examine the effect of these nutrients in combination on blood levels of cholesterol and related cardiovascular disease risk factors. DESIGN: Two open-label studies and 1 double-blind study are reported. SETTING: Outpatient clinical research setting. PATIENTS: Three groups (n=10, n=10, n=120) of hypercholesterolemic men and women (cholesterol levels >230 mg/dL) between the ages of 19 and 65 years were recruited. INTERVENTION: Subjects were randomized to consume either 270 mg citrus flavonoids plus 30 mg tocotrienols (S) or placebo (P) daily for a period of 4 weeks (group 1 [G1] and group 2 [G2]) or 12 weeks (group 3 [G3]). MAIN OUTCOME MEASURES: Measurements of fasting levels of blood cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides were made at baseline and 4 weeks (all groups) and at 8 weeks and 12 weeks (G3). RESULTS: Daily treatment with S significantly improved cardiovascular parameters compared to P in all groups. Significant reductions were shown in total cholesterol (20%-30%), LDL (19%-27%), apolipoprotein B (21%), and triglycerides (24%-34%). HDL levels remained unchanged in G1 and G2 but increased 4% (nonsignificant) in G3 and was accompanied by a significant increase in apolipoprotein A1 (5%).
