Double-Blind, Placebo-Controlled Study of Effects of Plant Sterol Enriched Vegetable Juice on Serum Cholesterol Concentrations in Mildly Hypercholesterolemic Subjects and Safety Evaluation

Abstract

A double-blind, placebo-controlled study was carried out to determine the effective dosage of a vegetable and fruit juice mix, enriched with free plant sterol (sterol VFJ), on serum concentrations of cholesterol and safety assessment was made for normocholesterolemic and mildly hypercholesterolemic Japanese subjects as high dosage (HG: 1.6 g sterol/day), low dosage (LG: 0.8 g sterol/day) and placebo control groups (CG). All subjects were continuously monitored during a 12-week treatment period and serum cholesterol were measured. Throughout the experiment, the subjects were allowed to engage in normal daily activities. It is noteworthy that total cholesterol (T-C) and LDL-cholesterol (LDL-C) in LG and HG decreased significantly at 4, 8 and 12 weeks (LG: p <0.05; HG: p <0.01) compared to the baseline (0 weeks). The degree of change in T-C (DT-C) and LDL-C (DLDL-C) in HG and LG compared to CG was significant at 4, 8 and 12 weeks (LG: p < 0.05; HG: p < 0.01). Stratified analysis indicated T-C and LDL-C in LG and HG of high T-C (T-C 220 mg/dL) subjects (CG: n = 32; LG: n = 31; HG: n = 36) decreased significantly at 4, 8 and 12 weeks compared to the baseline (LG: p < 0.01; HG: p < 0.05). DT-C and DLDL-C in HG and LG compared CG significantly decreased at 8 and 12 weeks (LG: p <0.05; HG: p < 0.05). But in normal T-C (T-C< 220 mg/dL) subjects (CG: n = 19; LG: n = 19; HG: n = 18), T-C and LDL-C were significantly changed at some point during the period of treatment though not at 12 weeks. Sterol VFJ is thus shown less effective for diminishing serum lipid in normal and healthy subjects. Safety assessment data indicated significant change in some parameters, but which in all cases was within the normal range. No time-dependent or dosage-dependent change could be detected. From the present findings, sterol VFJ would appear a safe and effective beverage for improving serum lipid concentrations in normocholesterolemic and mildly hypercholesterolemic subjects.

Possible anti‐obesity effects of phytosterols and phytostanols supplementation in humans: A systematic review and dose–response meta‐analysis of randomized controlled trials

“…Forty‐seven studies had a single‐arm parallel group whereas 32 studies had a crossover design (Abumweis et al, ; de Graaf et al, ; De Smet et al, ; Demonty, Chan, Pelled, & Jones, ; Esther et al, ; Farquhar & Sokolow, ; Fuentes et al, ; Hallikainen et al, ; Hendriks, Weststrate, Van Vliet, & Meijer, ; Ho, Liu, & Loke, ; Jones, Vanstone, Raeini‐Sarjaz, & St‐Onge, ; Kassis, Vanstone, Abumweis, & Jones, ; Naumann, Plat, & Mensink, ; Neil, Meijer, & Roe, ; Ottestad et al, ; Plat et al, ; Plat & Mensink, ; Theuwissen & Mensink, ; Thomsen, Hansen, Christiansen, Green, & Berger, ; Volpe et al, ). Included studies were carried out in patient with dyslipidemia (Varady et al, ; Ottestad et al, ; Gylling, Hallikainen, Nissinen, & Miettinen, ; Bañuls et al, ; Hironaka, Shioya, Matsubara, Matsuoka, & Itakura, ; Sukmaniah et al, ; Becker et al, ; Stelmach‐Mardas et al, ; Furuncuoğlu, Başar, Alici, & Şengül, ; Abumweis et al, ; Cabezas, De Vries, Van Oostrom, Iestra, & Van Staveren, ; de Graaf et al, 2002; De Jong et al, ; Demonty et al, ; Fuentes et al, ; Gylling et al, ; Hallikainen, Kurl, Laakso, Miettinen, & Gylling, ; Hallikainen, Sarkkinen, Gylling, Erkkilä, & Uusitupa, ; Hallikainen & Uusitupa, ; Hendriks et al, ; Hsu et al, ; Jones et al, ; Jones et al, ; Kassis et al, ; Korpela et al, ; Lestiani et al, ; Matvienko et al, ; Neil et al, ; Plat & Mensink, ; Plat et al, ; Smet, Mensink, & Plat, ; Solà et al, ; Theuwissen and Mensink, 2007; Thomsen et al, ; Volpe et al, ; Woodgate, Chan, & Conquer, ), diabetes (Gao et al, …”

“…We concluded that PS supplementation was not able to affect percentage fat mass and WC in comparison with placebo consumption. However, the number of studies that assessed these effects was low, and these studies were very similar in terms of applied dosages and the duration of intervention periods (Cheung et al, ; De Smet et al, ; Hironaka et al, ; Hongu et al, ; Sialvera et al, ; Sukmaniah et al, ; Varady et al, ). Further studies that will apply different doses and duration of the interventions are needed to elucidate this relationship.…”

A dose-response and meta-analysis of phytosterols consumption on liver enzymes

“…Eighteen studies reported the effect of Phytosterol supplementation on liver function. Among the included studies one study, used two doses of Phytosterol (Hironaka et al , 2006) and two used three doses (Kurokawa et al , 2008; Davidson et al , 2001)and we considered as separate studies. These studies were published between 1996 and 2018.…”

“…Twelve of studies were from the Asian populations (Hironaka et al , 2006; Hsu et al , 2017; Javanmardi et al , 2018b; Kriengsinyos et al , 2015; Ishizaki et al , 2003; Matsuoka et al , 2004; Seki et al , 2003; Kurokawa et al , 2008; Takeshita et al , 2007), three from American populations (Davidson et al , 2001), and three from European populations (Gylling et al , 2010; Richter et al , 1996). The duration of intervention ranged from 4 to 52 weeks.…”

Cholesterol-Lowering Activity of Plant Sterol-Egg Yolk Lipoprotein Complex in Rats

“…Hironaka et al reported that plant sterol-enriched vegetable juice reduced serum total and LDL-cholesterol concentrations in Japanese subjects 20) . These reports suggest that the cholesterol-lowering activity of free plant sterols was maintained in a water-rich condition.…”