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        Efficacy and Safety of a Flaxseed Hull Extract in the Symptomatic Management of Benign Prostatic Hyperplasia: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Pilot Study

        Rudy Simons,Navneet Sonawane,Marian Verbruggen,Jayesh Chaudhary 한국식품영양과학회 2015 Journal of medicinal food Vol.18 No.2

        This exploratory study was designed to assess the effectiveness of a lignan-rich extract of flaxseed hulls (LinumLife EXTRA®) in alleviating symptoms in subjects with benign prostatic hyperplasia (BPH) compared with placebo. Two dosages of extract were compared against placebo in a double-blinded, randomized, parallel, multicenter study. Newly diagnosed cases of BPH in patients aged 45–75 years with an American Urological Association Symptom Index (AUASI) score of ≥ 13 were included. Study treatment consisted of 500 or 1000 mg of extract containing 100 mg (low-dose active [LDA] group, n = 26) or 200 mg (high-dose active [HDA] group, n = 26) of secoisolariciresinol diglucoside (SDG), respectively. The placebo (P) group (n = 28) received matching maltodextrin capsules. Sixty subjects (LDA [n = 19], HDA [n = 20], and P [n = 21]) completed the study as per the protocol requirements. Change in the AUASI score within a period of 8 weeks, from baseline to end of treatment, was assessed. Significant improvement of obstructive symptoms and management of irritable BPH symptoms was achieved in all groups after treatment. Due to a strong placebo effect, there was no statistical difference between the groups that were treated with flaxseed hull extract as compared with the placebo group. Treatment with flaxseed hull extract did not lead to adverse effects compared with placebo. Supplementation with flaxseed hull extract was found to be safe and well-tolerated and may have improved the quality of life of individuals with BPH. The significant placebo effect as well as the number of subjects per treatment group and the relative short duration of the study may explain the lack of statistical significance between groups.

      • KCI등재

        Preventive Effects of Lignan Extract from Flax Hulls on Experimentally Induced Benign Prostate Hyperplasia

        Jean-Francois Bisson,Sophie Hidalgo,Rudy Simons,Marian Verbruggen 한국식품영양과학회 2014 Journal of medicinal food Vol.17 No.6

        Consumption of diet rich in lignans may decrease the risk of some chronic hormonal conditions such as benignprostatic hyperplasia (BPH). This study investigated whether a lignan-rich extract from flaxseed hulls, LinumLife EXTRA(LLE), could prevent BPH using the testosterone propionate (TP)-induced BPH rat model. Male Wistar-Unilever rats wererandomly divided into four groups of 12 rats each: a negative control group fed with control diet and receiving dailysubcutaneous injections of corn oil without TP, and three groups fed with control diet (positive control), diet containing 0.5% LLE (LLE 0.5) or 1.0% LLE (LLE 1.0) and receiving daily subcutaneous injections of TP in corn oil. Treatments with diets started 2 weeks before the induction of BPH and were carried out for 5 consecutive weeks. The influence of TP and LLE on body weight (BW), food and water consumptions, and enterolactone (ENL) levels in serum and urine of rats was examined at the end of the 5-week treatment period. TP significantly diminished the mean body weight gain (MBWG) of positive control rats and their food and water consumptions while LLE reduced significantly this MBWG reduction in a dose-dependent manner. The lignan-rich extract significantly inhibited TP-induced prostate size ratio (prostate weight/rat BW) increase in comparison with positive controls (P < .001). This effect was dose dependent. Higher serum and urine levels of ENL correlated well with the dose of extract provided to rats. It was concluded that the lignan-rich flaxseed hull extract prevented the TP-induced BPH indicating it might be beneficial in the prevention of BPH.

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