Effects of Unripe Black Raspberry Extract Supplementation on Male Climacteric Syndrome and Voiding Dysfunction: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Male climacteric syndrome (MCS) is a medical condition that can affect middle-aged men whose testosterone levels begin to decline considerably. These symptoms may include fatigue, decreased libido, mood swings, and disturbed sleep. MCS can be managed with lifestyle modifications and testosterone replacement. However, testosterone therapy may cause number of side effects, including an increased risk of cardiovascular issues. This study aims to evaluate the efficacy and safety of unripe black raspberry extract (BRE) against MCS and voiding dysfunction in men with andropause symptoms. A total of 30 subjects were enrolled and randomly assigned to the BRE group (n = 15) or the placebo group (n = 15). Participants were supplemented with 4800 mg BRE or placebo twice daily for 12 weeks. The impact of BRE was assessed using the Aging Male’s Symptoms (AMS scale), International Prostate Symptom Score (IPSS) and the IPSS quality of life index (IPSS-QoL). Additionally, male sex hormones, lipid profiles, and anthropometric indices were assessed 6 and 12 weeks after treatment. The AMS scores did not differ significantly between the two groups. In the BRE group, the total IPSS and IPSS-QoL scores decreased significantly after 12 weeks compared to baseline (p < 0.05), but there was no significant difference compared to the placebo group. However, a significant difference was observed in the IPSS voiding symptoms sub-score compared to the placebo group. Furthermore, LDL-C and TC levels were also significantly lower in the BRE group than in the placebo group (p < 0.05). Collectively, the study provides strong evidence supporting the safety of BRE as a functional food and its supplementation potentially enhances lipid metabolism and alleviates MCS and dysuria symptoms, limiting the development of BPH.

The effects of raspberry consumption on lipid profile and blood pressure in adults: A systematic review and meta‐analysis

“…For evaluating the 16 studies, it was necessary to read their full text, which led to the exclusion of five studies due to having no RCT design ( n = 1), combination therapy ( n = 3), and lack of a control group ( n = 1). Finally, 11 studies (13 arms) with 512 participants were eligible to be included in this meta‐analysis (An et al., 2016 ; Cho et al., 2020 ; Franck et al., 2020 ; Franck et al., 2022 ; Jeong, Hong, et al., 2016 ; Jeong et al., 2014 ; Jeong, Kim, et al., 2016 ; Jung et al., 2023 ; Mosah et al., 2015 ; Park et al., 2015 ; Schell et al., 2019 ) (Figure 1 ).…”

“…In this study, complaints of fatigue, skin rash, and abdominal pain were reported even in the placebo control group. In another study conducted by Jung et al (2023), although the relationship between intervention and complaint was ruled out, complications including oral leukoplakia, heartburn, elevated T-PSA, upper respiratory infection, and dysuria were reported in the group receiving black raspberry extract. Abbreviations: L, Low; H, High; U, Unclear.…”

“…The sample size of the included studies varied from 22 (Schell et al, 2019) to 77 participants (Cho et al, 2020). The intervention subjects' mean age ranged from 24.65 (Park et al, 2015) to 63.8 years (Jung et al, 2023), and the mean BMI ranged from 23.52 (Cho et al, 2020) to 35.3 kg/m 2 (Schell et al, 2019). Interventions were performed on healthy people (Park et al, 2015), and individuals with borderline-high cholesterol levels (Cho et al, 2020),…”

“…Among the included studies, five did not report the adverse effects that occurred (Franck et al, 2022;Jeong et al, 2014;Mosah et al, 2015;Park et al, 2015;Schell et al, 2019), no adverse events occurred in four studies (Cho et al, 2020;Franck et al, 2020;Jeong, Kim, et al, 2016), and complications were reported in only two studies (An et al, 2016;Jung et al, 2023). In An et al (2016), the side effects in the group that received raspberry with a high dose included insomnia, nausea, and skin rash, and in the group that received raspberry with a low dose, it included diarrhea, nausea, abdominal pain, skin rash, and fever.…”

“…The sensitivity analysis showed that the general result of the effect of raspberry intake on HDL-C and SBP did not depend on the presence of a specific study. The result of the effect of raspberry intake on TC and TG significantly changed after omitting the study conducted by))(Park et al, 2015), and Jung et al (WMD: −6.04 mg/dL (−12.07, −0.02))(Jung et al, 2023), respectively. Also, the pooled effect sizes for LDL-C after omitting the effect sizes of Park et al (WMD: −7.30 mg/dL (−13.14, −1.45))(Park et al, 2015), and for DBP after removingJeong et al (WMD:…”