Kalman Douglas S, Feldman Samantha, Vazquez Rafeal Rivas, Krieger Diane R
Miami Research Associates, Endocrinology and Nutrition Department, 6141 Sunset Drive, Suite 301, Miami, FL 33143, USA.
Miami Research Associates, Neurosciences Department, 6141 Sunset Drive, Suite 301, Miami, FL 33143, USA.
Foods. 2015 May 8;4(2):130-139. doi: 10.3390/foods4020130.
The primary objective of this pilot clinical trial was to evaluate the effects of UP165 (derived from L., commonly known as corn) over time. The secondary objective was the comparison for outcomes -adenosyl-methionine (SAM-e). Subjects with mild depression or anxiety were given the Beck Depression Inventory second edition (BDI-II), the Beck Anxiety Inventory (BAI), and the Schwartz Outcome Scale (SOS-10). Forty-two subjects (21-65 years old) were randomized to eight-weeks of supplementation with UP165 or SAM-e with questionnaires being administered at randomization, week four and eight. Those receiving UP165 achieved significant reduction from baseline at weeks four and eight, respectively for the BDI-II, as well as a trend for reduction in BAI at week four and significance at week eight. There was a trend for improvement on the SOS at week four and significance at week eight. SAM-e demonstrated a trend for improvement on the BDI-II by week eight over the UP165 with no differences between the two for the BAI or the SOS. Overall, this study indicates that there may be benefit to UP165 for mood enhancement in those with mild depression or anxiety. Randomized placebo comparator trials appear warranted.
这项初步临床试验的主要目的是评估UP165(源自L.,俗称玉米)随时间的效果。次要目的是比较结局——腺苷甲硫氨酸(SAM-e)。对患有轻度抑郁或焦虑的受试者进行了贝克抑郁量表第二版(BDI-II)、贝克焦虑量表(BAI)和施瓦茨结局量表(SOS-10)评估。42名受试者(年龄在21至65岁之间)被随机分为两组,分别接受为期八周的UP165或SAM-e补充剂治疗,并在随机分组时、第四周和第八周进行问卷调查。接受UP165治疗的受试者在第四周和第八周时,BDI-II得分相对于基线分别有显著降低,第四周时BAI得分有降低趋势,第八周时具有显著性。第四周时SOS有改善趋势,第八周时具有显著性。到第八周时,SAM-e在BDI-II上相对于UP165有改善趋势,在BAI或SOS方面两者无差异。总体而言,这项研究表明,UP165可能对改善轻度抑郁或焦虑患者的情绪有益。随机安慰剂对照试验似乎很有必要。