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• W3098348534 abstract "<h3>Importance</h3> Effective strategies for preventing type 2 diabetes are needed. Many people turn to complementary medicines, but there is little well-conducted scientific evidence to support their use. <h3>Objective</h3> To assess the efficacy of α-cyclodextrin for cholesterol control and that of hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity. <h3>Design, Setting, and Participants</h3> This 6-month double-blind, placebo-controlled, randomized clinical trial, with a 2 × 2 factorial design, was conducted between July 2015 and October 2018 at 2 locations in Sydney, Australia. Eligible participants were aged 18 years or older, had a body mass index (weight in kilograms divided by height in meters squared) of 25 or higher, and had prediabetes within 6 months of study entry according to the American Diabetes Association guidelines. Data analysis was performed from May to August 2019. <h3>Interventions</h3> Participants were randomized to 1 of 4 groups to take active or placebo versions of each supplement (α-cyclodextrin plus hydrolyzed ginseng, α-cyclodextrin plus placebo, placebo plus hydrolyzed ginseng, or placebo plus placebo) for 6 months. All participants received dietetic advice for weight loss. <h3>Main Outcomes and Measures</h3> The primary outcomes were the differences in total cholesterol and fasting plasma glucose between groups after 6 months. The primary analysis used the intention-to-treat principle. Multiple predetermined subsample analyses were conducted. <h3>Results</h3> A total of 401 participants were eligible for the study (248 women [62%]; mean [SD] age, 53.5 [10.2] years; mean [SD] body mass index, 34.6 [6.2]). One hundred one patients were randomized to receive α-cyclodextrin plus hydrolyzed ginseng, 99 were randomized to receive α-cyclodextrin plus placebo, 101 were randomized to receive placebo plus hydrolyzed ginseng, and 100 were randomized to receive placebo plus placebo. For 200 participants taking α-cyclodextrin compared with 201 participants taking placebo, there was no difference in total cholesterol after 6 months (−1.5 mg/dL; 95% CI, −6.6 to 3.5 mg/dL;<i>P</i> = .51). For 202 participants taking hydrolyzed ginseng compared with 199 participants taking placebo, there was no difference in fasting plasma glucose after 6 months (0.0 mg/dL; 95% CI, −1.6 to 1.8 mg/dL;<i>P</i> = .95). Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants;<i>P</i> = .006) and cough (8 participants vs 1 participant;<i>P</i> = .02). Use of hydrolyzed ginseng was associated with rash and pruritus (13 participants vs 2 participants;<i>P</i> = .006). Only 37 of 401 participants (9.2%) experienced these adverse events. <h3>Conclusions and Relevance</h3> Although they are safe for use, there was no benefit found for either α-cyclodextrin for cholesterol control or hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity. <h3>Trial Registration</h3> Australian New Zealand Clinical Trials Registry Identifier:ACTRN12614001302640" @default.
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• W3098348534 date "2020-11-17" @default.
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• W3098348534 title "Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes" @default.
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• W3098348534 doi "https://doi.org/10.1001/jamanetworkopen.2020.23491" @default.
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