Human studies – In the first randomized, double-blind, placebo-controlled clinical trial outside China of Harunobu Amagase et al. that has examined the general effects of the oral consumption of the standardized goji berry juice GoChi™ (120 ml/d which is equivalent to 150 g of fresh fruit, the amount traditionally prescribed by TCM specialists) to healthy adults (N 34) for 14 days an increase in subjective feelings of general well-being and improvement of neurologic/psychological performance and gastrointestinal functions have been reported. Additionally, of the 9 female subjects in the GoChi group, 5 reported a decrease in nonspecific complaints and pain during their menstrual cycle. Two male subjects in the GoChi group noted improvement in skin conditions, and 1 female subject reported harder nails. None of the subjects in the placebo group shared any information regarding any noticeable changes during the treatment period. [/fusion_text][fusion_text]Following this research, another study under leadership of Dr. Harunobu Amagase investigated the effects of consumption of 60 mlx2/d of goji juice (GoChi) containing 1632 mg of LBP on antioxidant markers (serum levels of superoxide dismutase (SOD), glutathione peroxidase (GSHPx), and lipid peroxidation (indicated by decreased levels of malondialdehyde (MDA)) in 50 Chinese healthy adults aged 55 to 72 years. The study lasted for 30 days. At the post intervention time point, serum SOD activity was significantly higher in the GoChi group (by 8.10%) relative to the level observed in the placebo group. GSH-Px had increased by 9.04% in the GoChi group. The MDA level had decreased by 5.95% in the GoChi group. As far as EFSA is concerned, concentrations of MDA in blood could be used as a supportive factor next to measurements of F2-isoprostanes or in vivo LDL oxidation, neither of which been assessed during this research. Induction of antioxidant enzymes SOD and GSH-Px could be considered a beneficial physiological effect “only if such changes provide (additional) protection of cells and molecules from oxidative damage, which should be demonstrated in vivo in humans.” The results showed that daily consumption of GoChi significantly increased several immunological responses (number of lymphocytes and levels of interleukin-2 and immunoglobulin G compared to pre-intervention and the placebo group) and subjective feelings of general well-being without any adverse reactions. The antioxidant status was measured by high-performance liquid chromatography. Further, 13 individuals from the placebo group demonstrated hypopigmentation and 11 individuals from the placebo group demonstrated soft drusen accumulation in the macula, whereas the LWB group remained stable. Antioxidant capacity levels were stable over time for the placebo group but increased with 57% with the LWB. However, the mechanism of action of LBP remains unclear, given the lack of relationship between change in plasma zeaxanthin and change in macular characteristics. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health.
