A double-blind, randomized controlled trial (RCT) of L-carnitine and conjugated linoleic acid-based health food with health claims

Y. Yonei, Yoko Takahashi, Miwako Watanabe, T. Yoshioka
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引用次数: 10

Abstract

In the present study, we investigated the physical effect of health food (supplement) which contains L-carnitine (200mg) and conjugated linoleic acid (700mg) for 8 weeks with a double-blind, randomized controlled non-crossover design. Overweight individuals (17 males and 18 females; age: 48.3±6.6yrs; BMI: 25.5±2.6) were assigned to either Study Group (n=18) or Control Group (n=17). A small increase in serum levels of HbAlc (3.3%) and CRP (35.3%) was noted in the Study Group (p<0.05), and a significant increase in urinary isoprostane production rate (38.9%) and its creatinine -adjusted value (isoprostane/CRE) (44.4%), which is a marker for damage of fatty acids by free radicals. No effect was observed for indicators related to body composition and lipid metabolism. The results showed a significant improvement for the following subjective symptoms: “Easily break into a sweat”, “Irritability”, “Easily angered”, “Sense of tension”, however, “Early satiety” exacerbated. The sole parameter we found a significant intergroup difference in rate of change was in urinary isoprostane production rate and its creatinine-corrected value, and the score obtained in the questionnaire for “Easily angered”. In conclusion, these findings suggest that the consumption of the test compounds with L-carnitine and conjugated linoleic acid can reduce some mental symptoms; however, the efficacy on QOL was equivocal. As unfavorable phenomenon, elevation of HbAlc, CRP and urinary isoprostane were observed during the study.
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一个双盲,随机对照试验(RCT)左旋肉碱和共轭亚油酸为基础的健康食品与健康声明
本研究采用双盲、随机对照、非交叉试验设计,对含左旋肉碱(200mg)和共轭亚油酸(700mg)的保健食品(补充剂)进行为期8周的物理效应研究。超重个体(17名男性和18名女性;年龄:48.3±6.6岁;BMI: 25.5±2.6)的患者分为研究组(n=18)和对照组(n=17)。研究组患者血清HbAlc(3.3%)和CRP(35.3%)水平小幅升高(p<0.05),尿异前列腺素生成率(38.9%)及其肌酐调节值(异前列腺素/CRE)(44.4%)显著升高(异前列腺素/CRE是自由基对脂肪酸损伤的标志)。未观察到对身体成分和脂质代谢相关指标的影响。结果显示,“易出汗”、“易怒”、“易生气”、“紧张感”等主观症状有明显改善,但“早饱感”加重。我们发现组间变化率有显著差异的唯一参数是尿异前列腺素生成率及其肌酐校正值,以及“易激怒”问卷得分。综上所述,这些发现表明,食用含有左旋肉碱和共轭亚油酸的试验化合物可以减轻某些精神症状;然而,对生活质量的影响是模棱两可的。作为一种不利现象,在研究过程中观察到HbAlc、CRP和尿异前列腺素的升高。
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