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Clinical research study
Effects of Alpha-Lipoic Acid on Body Weight in Obese Subjects

https://doi.org/10.1016/j.amjmed.2010.08.005Get rights and content

Abstract

Purpose

Alpha-lipoic acid is an essential cofactor for mitochondrial respiratory enzymes that improves mitochondrial function. We previously reported that alpha-lipoic acid markedly reduced body weight gain in rodents. The purpose of this study was to determine whether alpha-lipoic acid reduces body weight in obese human subjects.

Methods

In this randomized, double-blind, placebo-controlled, 20-week trial, 360 obese individuals (body mass index [BMI] ≥30 kg/m2 or BMI 27-30 kg/m2 plus hypertension, diabetes mellitus, or hypercholesterolemia) were randomized to alpha-lipoic acid 1200 or 1800 mg/d or placebo. The primary end point was body weight change from baseline to end point.

Results

The 1800 mg alpha-lipoic acid group lost significantly more weight than the placebo group (2.1%; 95% confidence interval, 1.4-2.8; P < .05). Urticaria and itching sensation were the most common adverse events in the alpha-lipoic acid groups, but these were generally mild and transient.

Conclusion

Alpha-lipoic acid 1800 mg/d led to a modest weight loss in obese subjects. Alpha-lipoic acid may be considered as adjunctive therapy for obesity.

Section snippets

Participant Recruitment

This study was conducted in accordance with the principles described in the Declaration of Helsinki. The study protocol was approved by the institutional review board at each center, and all subjects provided written informed consent.

A variety of recruitment strategies were used to attract potential participants. The sponsor company developed several materials, including brochures, posters, and newspaper advertisements. All advertisements were approved by the institutional review board at each

Clinical Characteristics

Of the 539 recruited subjects, 360 were randomly assigned to the 3 groups; there were no differences in baseline characteristics among the 3 groups (Table 1). Of the 360 randomized subjects, 228 completed the 20-week double-blind trial (Figure 1). There were no significant differences in baseline clinical or laboratory characteristics between subjects who completed the study and those who were withdrawn (data not shown). Overall withdrawal rates did not differ among the 3 groups, and

Discussion

To our knowledge, this is the first study to show that alpha-lipoic acid treatment led to a significant weight reduction in obese human subjects. Subjects who completed 20 weeks of treatment with 1800 mg/d alpha-lipoic acid showed modest but statistically significant reductions in body weight and BMI. Moreover, the percentage of subjects with a ≥5% loss in initial body weight was significantly higher in the 1800 mg/d alpha-lipoic acid group than in the placebo group.

Alpha-lipoic acid was

Limitations

Our study has several limitations. The length of the trial (20 weeks) was relatively short. Moreover, because all participants were prescribed a hypocaloric diet, our findings may be applicable only in the context of energy restriction. It should also be highlighted that our study was conducted in Korea. The adiposity and metabolic characteristics of Asian individuals differ from those of Western or other populations.28 Thus, additional studies are required to determine whether alpha-lipoic

Conclusions

We showed that 1800 mg/d of oral alpha-lipoic acid was effective in achieving significant weight loss in obese subjects. Although the therapeutic potency of alpha-lipoic acid was modest, no serious side effects were observed. Differences in side effects from currently used anti-obesity drugs suggest that alpha-lipoic acid may be effective as an adjunctive medication for obesity. Further studies are needed to determine the adequate dosage of alpha-lipoic acid and its long-term safety and

Acknowledgments

The authors acknowledge all dietitians, clinical pharmacists, and coordinators who helped with this study. The authors also thank Sang-Ki Kim, Young-Taek Kim, and Chan-Hee Kim of Dalim BioTech Co, Ltd, for support of the study.

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      The administration of ALA resulted in a significant reduction of the weight and BMI in the treatment group compared to the control group. This was in agreement with the results of several studies in adults [12–17]. ALA stimulates the reduction of the body weight and BMI by decreasing the food intake possibly by suppressing hypothalamic AMP-activated protein kinase (AMPK) activity beside enhancing energy expenditure [22].

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    Funding: This work was supported by the Korea Health Industry Development Institute (0412-DB00-0101-0006). This study was funded in part by Dalim BioTech Co, Ltd, Seoul, Republic of Korea.

    Conflict of Interest: None of the authors have any conflicts of interest associated with the work presented in this manuscript.

    Authorship: All authors had access to the data and played a role in writing this manuscript.

    Both authors contributed equally to this work.

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