Hoogenboom Tim C H, Patel Nayna, Cook Nicola A, Williams Roger, Taylor-Robinson Simon D, Lim Adrian K P
Department of Surgery and Cancer, Imperial College London, St Mary's Hospital, London, United Kingdom.
Institute of Hepatology, London, United Kingdom.
Integr Med (Encinitas). 2020 Jun;19(3):30-34.
There have been isolated reports of hepatotoxicity, usually manifested by transient liver function test abnormalities. While the European Food Safety Authority has recommended that whole leaf products containing the rind of the plant should not be used for human oral consumption, those gels made of the treated plant pulp alone are considered safe for daily consumption, provided recommended quantities are not exceeded. We aimed to assess hepatic function in healthy volunteers consuming the purified plant pulp gel over a 60 day period.
35 healthy volunteers consumed the maximum recommended daily dose of 2 oz (57 mL) of gel twice daily for a total of 60 days. The participants attended an initial baseline visit where biochemical measurements of hepatic synthetic function were obtained, and each volunteer underwent hepatic ultrasound with elastography, superb microvascular imaging and image quantification. Further visits were undertaken at days 30 and 60 to undergo the same biochemical and imaging measurements of liver function to monitor if there were any changes in the parameters measured.
Seven volunteers failed to complete the study, citing unspecified gastrointestinal upset and/or an inability to tolerate the taste of the gel. None of these individuals had disturbance of biochemical or imaging parameters of hepatic function. Of the remaining 27 healthy volunteers, none had a change in either biochemical indices of liver function, or of ultrasound markers of hepatic blood flow or liver tissue elasticity after 60 days of gel consumption. However, there was a non-significant reduction in serum homocysteine levels as the only detectable change in the cohort.
Despite reports of potential hepatotoxicity with some products, in this healthy cohort, extended consumption of purified plant-pulp gel did not have any detectable effects on hepatic function, blood flow or tissue elasticity.
已有关于肝毒性的个别报道,通常表现为肝功能检查结果短暂异常。虽然欧洲食品安全局建议含该植物外皮的整叶产品不应供人类口服,但仅由经处理的植物果肉制成的凝胶在不超过推荐量的情况下被认为可安全每日食用。我们旨在评估健康志愿者在60天内食用纯化植物果肉凝胶后的肝功能。
35名健康志愿者每天两次服用最大推荐日剂量2盎司(57毫升)的凝胶,共60天。参与者参加了首次基线访视,获取了肝脏合成功能的生化测量值,且每位志愿者都接受了肝脏超声检查,包括弹性成像、超微血管成像和图像定量分析。在第30天和第60天进行了进一步访视,以进行相同的肝功能生化和成像测量,以监测测量参数是否有任何变化。
7名志愿者因未指明的胃肠道不适和/或无法耐受凝胶味道而未能完成研究。这些个体均未出现肝功能生化或成像参数紊乱。在其余27名健康志愿者中,食用凝胶60天后,肝功能生化指标、肝血流超声标志物或肝组织弹性均无变化。然而,血清同型半胱氨酸水平有非显著性降低,这是该队列中唯一可检测到的变化。
尽管有报道称某些产品存在潜在肝毒性,但在这个健康队列中,长期食用纯化植物果肉凝胶对肝功能、血流或组织弹性没有任何可检测到的影响。