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dc.contributor.authorFeinberg, T.*
dc.contributor.authorWieland, L.S.*
dc.contributor.authorMiller, L.E.*
dc.date.accessioned2019-03-29T14:47:34Z
dc.date.available2019-03-29T14:47:34Z
dc.date.issued2019
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85059676154&doi=10.1186%2fs13063-018-3032-6&partnerID=40&md5=2fc73e9fcff814c5f12767dbe73fb98b
dc.identifier.urihttp://hdl.handle.net/10713/8657
dc.description.abstractBackground: Prediabetes describes a state of hyperglycemia outside of normal limits that does not meet the criteria for diabetes diagnosis, is generally symptomless, and affects an estimated 38% of adults in the United States. Prediabetes typically precedes the diagnosis of type 2 diabetes, which accounts for increased morbidity and mortality. Although the use of dietary and herbal supplements is popular worldwide, and a variety of single herbal medicines have been examined for glycemic management, the potential of increasingly common polyherbal formulations to return glycemic parameters to normal ranges among adults with prediabetes remains largely unexplored. The purpose of this study is to evaluate the efficacy of a commercially available, polyherbal dietary supplement on glycemic and lipid parameters in prediabetic individuals. Methods: In this multi-site, double-blinded, randomized controlled clinical trial, 40 participants with prediabetes will be randomized to either a daily oral polyherbal dietary supplement (GlucoSupreme™ Herbal; Designs for Health®, Suffield, CT, USA; containing cinnamon bark (Cinnamomum cassia), banaba leaf (Lagerstroemia speciosa standardized to 1% corosolic acid), kudzu root (Pueraria lobata standardized to 40% isoflavones), fenugreek seed (Trigonella foenum-graceum standardized to 60% saponins), gymnema leaf (Gymnema sylvestre standardized to 25% gymnemic acid), American ginseng root (Panax quinquefolius standardized to 5% ginsenosides), and berberine HCl derived from bark (Berberis aristata)) or placebo for 12 weeks. Short-, medium-, and comparatively long-term markers of glycemic control (blood glucose and fasting insulin, fructosamine, and glycated hemoglobin/A1c, respectively), and other glycemic parameters (GlycoMark, ?-cell function, and insulin sensitivity/resistance) will be obtained. Lipid profile (total cholesterol, LDL, HDL, and triglycerides), inflammation (hs-CRP), progression to type 2 diabetes mellitus, as well as safety indices (ALT, AST) will be obtained. An intention-to-treat analysis will be used to assess changes in study outcomes. Discussion: Treatment options for adults with prediabetes are currently limited. This study aims to evaluate the safety and efficacy of a commercially available dietary supplement in the popular, but as yet insufficiently studied, category of polyherbal formulas for the management of glycemic parameters and other biomarkers associated with prediabetes. Trial registration: ClinicalTrials.gov, ID: NCT03388762. Retrospectively registered on 4 January 2018. © 2019 The Author(s).en_US
dc.description.urihttps://dx.doi.org/10.1186/s13063-018-3032-6en_US
dc.language.isoen_USen_US
dc.publisherBioMed Central Ltd.en_US
dc.relation.ispartofTrials
dc.subjectAmerican ginsengen_US
dc.subjectBanabaen_US
dc.subjectbotanicalen_US
dc.subjectcinnamonen_US
dc.subjectFenugreeken_US
dc.subjectkudzuen_US
dc.subjectprediabetesen_US
dc.subject.meshBerberineen_US
dc.subject.meshGlucose Metabolism Disordersen_US
dc.subject.meshGymnemaen_US
dc.titlePolyherbal dietary supplementation for prediabetic adults: Study protocol for a randomized controlled trialen_US
dc.typeArticleen_US
dc.identifier.doi10.1186/s13063-018-3032-6
dc.identifier.pmid30616613


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