Immune activation of Bio-Germanium in a randomized, double-blind, placebo-controlled clinical trial with 130 human subjects: Therapeutic opportunities from new insights.

REGISTERED CLINICAL TRIAL: [NCT03677921]; www.clinicaltrials.gov [KCT0002726]; https://cris.nih.go.kr.

The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial.

BACKGROUND: Rubus coreanus (R. coreanus) possesses properties that may decrease cholesterol levels. METHODS: The effects of unripe R. coreanus (uRC) consumption on low-density lipoprotein (LDL) and total cholesterol levels related to decreased circulating apolipoprotein (Apo) B and oxidized LDL levels were evaluated. This randomized, double-blind, placebo-controlled study included subjects with borderline-high cholesterol levels (between 200 and 239 mg/dL) who consumed one capsule daily containing 600 mg of freeze-dried uRC extract (n = 39) or the placebo (n = 38). RESULTS: After 12 weeks, the uRC group showed reductions of 21.23 ± 4.36 mg/dL in total cholesterol levels (P = 0.007) and 15.61 ± 4.16 mg/dL in LDL cholesterol levels (P = 0.032). In addition, significantly greater reductions in Apo B levels were observed in the uRC group (- 3.48 ± 3.40 mg/dL), but Apo B levels were increased in the placebo group (6.21 ± 2.84 mg/dL; P = 0.032). Furthermore, a remarkably lower oxidized LDL level was detected in the uRC group (57.76 ± 2.07 U/L) than in the placebo group (66.09 ± 3.47 U/L) after 12 weeks of consumption (P = 0.044). CONCLUSIONS: Because of its cholesterol-lowering effect, uRC shows great promise as a therapeutic agent for subjects with borderline-high total blood cholesterol levels. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03649620 (8/28/2018, retrospectively registered).

Testosterone alters testis function through regulation of piRNA expression in rats.

Piwi-interacting RNAs (piRNAs) play a role in gene silencing of retrotransposons, maintenance of spermatogenesis and maturation in germlines. The piRNA and PIWI protein are essential for fertility. To reveal piRNA function associated with testosterone, we investigated the expression of piRNA and piwi protein in normal male rats and testosterone-treated rats. Normal Sprague-Dawley (SD) rats were randomly selected and sacrificed at neonatal to late adolescence stage stages (2, 9, 16, 20, 24, 28, 35, and 42 days, n = 6 each). Additional SD rats were divided into four groups: group 1 received weekly injections of testosterone enanthate (8 mg/100 g) during 1-3 weeks; group 2 during 3-5 weeks; group 3 during 1-5 weeks; and group 4 was the control (n = 20 each). These animals were sacrificed at an age of 60 days. We investigated piRNA, PIWI, and Ago3 protein levels using real-time PCR, Western blot, and immunohistochemistry in each group. In normal rats, PIWI protein and piRNA were expressed at P24. The expression of PIWI and piRNA gradually increased from adolescence to adulthood on Western blot, real-time PCR and immunohistochemistry. In testosterone-treated rats, the expression of PIWI protein was analyzed by Western blot and shown to be significantly increased in group 1 (neonatal to juvenile injection). In real-time PCR, the expression of piRNA after testosterone treatment was increased in all groups (G1 166.8 ± 2.7; G2 113.3 ± 4.6; G3 70.2 ± 1.5 vs. control, 32.87 ± 2.0, all p < 0.001). The expression of testosterone in adolescence induces the development of male genitourinary organs and spermatogenesis. At the same time, the sexual hormones may activate the piRNA and PIWI protein. Our data demonstrate that patterns of piRNA and PIWI expression are similar to the secretion pattern of testosterone, and that piRNA expression was increased after testosterone treatment. Therefore, testosterone may affect testis function through the regulation of piRNA expression in rats.