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左旋肉碱和共生元联合补充对肥胖女性人体测量指标和心血管代谢特征的改善作用:一项随机对照临床试验。

Ameliorating effects of L-carnitine and synbiotic co-supplementation on anthropometric measures and cardiometabolic traits in women with obesity: a randomized controlled clinical trial.

机构信息

Student Research Committee, Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Nutrition Research Center, Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Front Endocrinol (Lausanne). 2023 Oct 18;14:1237882. doi: 10.3389/fendo.2023.1237882. eCollection 2023.

DOI:10.3389/fendo.2023.1237882
PMID:37929031
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10622781/
Abstract

BACKGROUND

Obesity, a multifactorial disorder with pandemic dimensions, is conceded a major culprit of morbidity and mortality worldwide, necessitating efficient therapeutic strategies. Nutraceuticals and functional foods are considered promising adjuvant/complementary approaches for weight management in individuals with obesity who have low adherence to conventional treatments. Current literature supports the weight-reducing efficacy of pro/pre/synbiotics or L-carnitine; however, the superiority of the nutraceutical joint supplementation approach over common single therapies to counter obesity and accompanying comorbidities is well documented. This study was designed to assess the effects of L-carnitine single therapy compared with L-carnitine and multistrain/multispecies synbiotic co-supplementation on anthropometric and cardiometabolic indicators in women with obesity.

METHODS

The current placebo-controlled double-blind randomized clinical trial was performed on 46 women with obesity, randomly allocated to either concomitant supplementation [L-carnitine tartrate (2 × 500 mg/day) + multistrain/multispecies synbiotic (1 capsule/day)] or monotherapy [L-carnitine tartrate (2 × 500 mg/day) + maltodextrin (1 capsule/day)] groups for 8 weeks. Participants in both groups received healthy eating dietary advice.

RESULTS

Anthropometric, lipid, and glycemic indices significantly improved in both intervention groups; however, L-carnitine + synbiotic co-administration elicited a greater reduction in the anthropometric measures including body mass index (BMI), body weight, and neck, waist, and hip circumferences ( < 0.001, <0.001, <0.001, = 0.012, and =0.030, respectively) after adjusting for probable confounders. Moreover, L-carnitine + synbiotic joint supplementation resulted in a greater reduction in fasting blood sugar (FBS), insulin (though marginal), and homeostatic model assessment of insulin resistance (HOMA-IR) and more increment in quantitative insulin sensitivity check index (QUICKI; = 0.014, 0.051, 0.024, and 0.019, respectively) compared with the L-carnitine + placebo monosupplementation. No significant intergroup changes were found for the lipid profile biomarkers, except for a greater increase in high-density lipoprotein-cholesterol concentrations (HDL-C) in the L-carnitine + synbiotic group ( = 0.009).

CONCLUSION

L-carnitine + synbiotic co-supplementation was more beneficial in ameliorating anthropometric indices as well as some cardiometabolic parameters compared with L-carnitine single therapy, suggesting that it is a promising adjuvant approach to ameliorate obesity or associated metabolic complications through potential synergistic or complementary mechanisms. Further longer duration clinical trials in a three-group design are demanded to verify the complementary or synergistic mechanisms.

CLINICAL TRIAL REGISTRATION

www.irct.ir, Iranian Registry of Clinical Trials IRCT20080904001197N13.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/720a2dcccde3/fendo-14-1237882-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/40b536d0b5da/fendo-14-1237882-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/efcddc98570e/fendo-14-1237882-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/720a2dcccde3/fendo-14-1237882-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/40b536d0b5da/fendo-14-1237882-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/efcddc98570e/fendo-14-1237882-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93c8/10622781/720a2dcccde3/fendo-14-1237882-g003.jpg
摘要

背景

肥胖是一种具有流行特征的多因素疾病,被认为是全球发病率和死亡率的主要罪魁祸首,因此需要有效的治疗策略。营养保健品和功能性食品被认为是肥胖患者体重管理的有前途的辅助/补充方法,这些患者对常规治疗的依从性较低。目前的文献支持益生菌/益生元和左旋肉碱的减肥功效;然而,左旋肉碱联合多菌株/多种类益生菌补充的营养保健品联合补充方法在对抗肥胖及其伴随的合并症方面优于常见的单一疗法,这一点已经得到了很好的证明。本研究旨在评估与单独使用左旋肉碱相比,左旋肉碱和多菌株/多种类益生菌联合补充对肥胖女性的人体测量和心血管代谢指标的影响。

方法

本研究是一项安慰剂对照、双盲随机临床试验,共纳入 46 名肥胖女性,随机分为联合补充组(左旋肉碱酒石酸盐(2×500mg/天)+多菌株/多种类益生菌(1 粒/天))或单药治疗组(左旋肉碱酒石酸盐(2×500mg/天)+麦芽糊精(1 粒/天)),干预时间为 8 周。两组参与者均接受健康饮食的饮食建议。

结果

两组干预措施均显著改善了人体测量、血脂和血糖指数;然而,左旋肉碱+益生菌联合给药后,人体测量指标包括体重指数(BMI)、体重、颈部、腰部和臀部周长显著降低(<0.001、<0.001、<0.001、=0.012 和=0.030),调整可能的混杂因素后。此外,与单独使用左旋肉碱相比,左旋肉碱+益生菌联合补充还导致空腹血糖(FBS)、胰岛素(尽管略有下降)和稳态模型评估的胰岛素抵抗(HOMA-IR)显著降低,而定量胰岛素敏感性检查指数(QUICKI)显著升高(=0.014、0.051、0.024 和 0.019)。除高密度脂蛋白胆固醇(HDL-C)浓度在左旋肉碱+益生菌组显著升高(=0.009)外,两组间的血脂标志物无显著变化。

结论

与单独使用左旋肉碱相比,左旋肉碱+益生菌联合补充在改善人体测量指标以及一些心血管代谢参数方面更有益,表明通过潜在的协同或互补机制,它是改善肥胖或相关代谢并发症的有前途的辅助方法。需要进行更长时间的三臂临床试验,以验证互补或协同机制。

临床试验注册

www.irct.ir,伊朗临床试验注册处 IRCT20080904001197N13。

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