دورية أكاديمية
Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes: A Randomized Clinical Trial.
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. |
References: | BMC Complement Altern Med. 2014 Jul 11;14:237. (PMID: 25015735) Diabetes Care. 2013 Jan;36 Suppl 1:S11-66. (PMID: 23264422) Eur Heart J. 2016 Aug 1;37(29):2315-2381. (PMID: 27222591) PLoS One. 2014 Sep 29;9(9):e107391. (PMID: 25265315) Nutr Metab Cardiovasc Dis. 2005 Jun;15(3):149-60. (PMID: 15955462) J Gen Intern Med. 2010 Apr;25(4):284-90. (PMID: 20131023) Chem Pharm Bull (Tokyo). 1985 Feb;33(2):869-72. (PMID: 4017130) Lipids Health Dis. 2016 Jul 12;15(1):115. (PMID: 27405337) Clin Obes. 2019 Aug;9(4):e12324. (PMID: 31172667) J Ginseng Res. 2014 Oct 15;38(4):239-43. (PMID: 25379002) Diabetes Obes Metab. 2012 Jun;14(6):523-30. (PMID: 22192338) Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. (PMID: 17013969) Obesity (Silver Spring). 2011 Jun;19(6):1200-4. (PMID: 21127475) Diabetes. 2002 Jun;51(6):1851-8. (PMID: 12031973) Lipids Health Dis. 2017 Feb 22;16(1):45. (PMID: 28228137) Metabolism. 2006 Feb;55(2):195-202. (PMID: 16423626) Biol Pharm Bull. 1998 Mar;21(3):245-9. (PMID: 9556154) Medicine (Baltimore). 2016 Feb;95(6):e2584. (PMID: 26871778) Drug Metab Dispos. 2003 Aug;31(8):1065-71. (PMID: 12867496) Diabetes Res Clin Pract. 2011 Dec;94(3):311-21. (PMID: 22079683) |
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 |
تدمد: | 2574-3805 |
---|---|
DOI: | 10.1001/jamanetworkopen.2020.23491 |