دورية أكاديمية
أعرض في EDS

Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes: A Randomized Clinical Trial.

التفاصيل البيبلوغرافية
العنوان: Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes: A Randomized Clinical Trial.
المؤلفون: Bessell E; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia., Fuller NR; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia., Markovic TP; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.; Metabolism and Obesity Services, Royal Prince Alfred Hospital, Camperdown, Australia., Lau NS; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.; Metabolism and Obesity Services, Royal Prince Alfred Hospital, Camperdown, Australia., Burk J; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia., Hendy C; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia., Picone T; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia., Li A; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.; Sydney Health Economics, Sydney Local Health District, Camperdown, Australia., Caterson ID; The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.; Metabolism and Obesity Services, Royal Prince Alfred Hospital, Camperdown, Australia.
المصدر: JAMA network open [JAMA Netw Open] 2020 Nov 02; Vol. 3 (11), pp. e2023491. Date of Electronic Publication: 2020 Nov 02.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet ISSN: 2574-3805 (Electronic) Linking ISSN: 25743805 NLM ISO Abbreviation: JAMA Netw Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Chicago, IL : American Medical Association, [2018]-
مواضيع طبية MeSH: Panax*, Blood Glucose/*drug effects , Cholesterol, HDL/*drug effects , Cholesterol, LDL/*drug effects , Plant Extracts/*pharmacology , alpha-Cyclodextrins/*pharmacology, Adult ; Complementary Therapies ; Diabetes Mellitus, Type 2/prevention & control ; Double-Blind Method ; Female ; Glycemic Control/methods ; Humans ; Male ; Middle Aged ; Plant Extracts/therapeutic use ; Prediabetic State/metabolism ; alpha-Cyclodextrins/therapeutic use
مستخلص: Importance: 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.
Objective: 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.
Design, Setting, and Participants: 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.
Interventions: 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.
Main Outcomes and Measures: 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.
Results: 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; P = .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; P = .95). Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants; P = .006) and cough (8 participants vs 1 participant; P = .02). Use of hydrolyzed ginseng was associated with rash and pruritus (13 participants vs 2 participants; P = .006). Only 37 of 401 participants (9.2%) experienced these adverse events.
Conclusions and Relevance: 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.
Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001302640.
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سلسلة جزيئية: ANZCTR ACTRN12614001302640
المشرفين على المادة: 0 (Blood Glucose)
0 (Cholesterol, HDL)
0 (Cholesterol, LDL)
0 (Plant Extracts)
0 (alpha-Cyclodextrins)
Z1LH97KTRM (alpha-cyclodextrin)
تواريخ الأحداث: Date Created: 20201117 Date Completed: 20210114 Latest Revision: 20210114
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC7672512
DOI: 10.1001/jamanetworkopen.2020.23491
PMID: 33201232
قاعدة البيانات: MEDLINE
الوصف
تدمد:2574-3805
DOI:10.1001/jamanetworkopen.2020.23491