Double Blind Study of Health Claims for Food Containing Extract of Kabanoanatake (Charga: Fuscoporia obliqua) (RCT: randomized controlled trial)

Abstract

We investigated the health claims of food containing Kabanoanatake (Charga: Fuscoporia obliqua) in terms of general body function in a double blind study using three Groups, control, Charga 5ml Group and Charga 15ml Group, each of which consisted of 20 subjects totaling 60 healthy adult volunteers (male: 23; female; 37, age: 45.7±6.9 years).For the Charga 5ml Group, systolic blood pressure (-3.72 %, p=0.046) and diastolic blood pressure (-3.47 %, p=0.018) were significantly lowered, while triglyceride (36.01 %, p=0.050) was increased. Also, slight changes were observed in total body water (-0.70 %, p=0.036), total body muscle (-0.69 %, p=0.034), fat-free mass (-0.72 %, p=0.022), total skeletal muscle (-1.35 %, p=0.005), basal metabolism (-0.60 %, p=0.013), HbAlc (1.57 %, p=0.034) and Cl (-1.19 %, p=0.019). Among oxidization stress markers, lipid peroxide (-7.89 %, p=0.006) was significantly improved. For mental and physical symptoms, significant improvements were observed in “Cold skin” (p=0.008) and “Inability to sleep because of worries” (p=0.008), while no parameter showed any aggravation. The Charga 15ml Group showed a significant improvement in the score for “loss of motivation” (p=0.042) for physical and mental symptoms. Apart from this, a slight but significant change was observed in Cl (-1.18 %, p=0.016), while aggravation was noted for “frequent urination” (p=0.049).The parameters which showed a dose-dependent change in terms of administration of Charga were from the blood test (lowering of fasting insulin level), physical symptoms on the common interview sheet on aging and the QOL (improved score in “stiff shoulders”), mental symptoms (an improvement in the scores for “loss of motivation”, “daily life is not enjoyable”, “pessimism” and “feeling of anxiety for no special reason”. While “weight loss; thin” and “Easily breaking into a sweat” showed a slight increases in their respective scores, the increase in the score for “frequent urination” was comparatively remarkable. There was no significant change in immune activity using the number of NK cells as a benchmark parameter. In conclusion, taking the balance between parameters that showed effects and aggravation into consideration, the preferability of two doses of Charga 5ml or 15ml/day seemed equivocal. As unfavorable phenomenon, frequent urination and mild elevation of γ-GTP and triglyceride were observed during the study.