title: Synergistic in vitro antioxidant activity and observational clinical trial of F105, a phytochemical formulation including Citrus bergamia, in subjects with moderate cardiometabolic risk factors.
abstract: We examined the clinical safety and efficacy of F105 in 11 subjects with moderate dyslipidemia. F105 is a combination of bergamot fruit extract (Citrus bergamia, BFE) and 9 phytoextracts selected for their ability to improve the antioxidant and anti-inflammatory activity of BFE. In vitro F105 exhibited a synergistic inhibition of oxygen radical absorbing capacity, peroxynitrite formation, and myeloperoxidase activity. Following 12 weeks of F105 daily, no treatment-related adverse events or changes in body mass were seen. Statistically significant changes were noted in total cholesterol (-7.3%), LDL-cholesterol (-10%), non-HDL cholesterol (-7.1%), cholesterol/HDL (-26%), and apolipoprotein B (-2.8%). A post hoc analysis of 8 subjects with HbA1c > 5.4 and HOMA-IR score > 2 or elevated triglycerides revealed additional statistically significant changes in addition to those previously observed in all subjects including triglycerides (-27%), oxLDL (-19%), LDL/HDL (-25%), triglycerides/HDL (-27%), oxLDL/HDL (-25%), and PAI-1 (-37%). A follow-up case report of a 70-year-old female patient, nonresponsive to statin therapy and placed on F105 daily, demonstrated improved cardiometabolic variables over 12 weeks similar to the subgroup. In summary, F105 was clinically well-tolerated and effective for ameliorating dyslipidemia in subjects with moderate cardiometabolic risk factors, particularly in the individuals with HbA1c > 5.4%.
authors.affiliation: a Bionexus, Ltd., 53 Brown Road, Suite B, Ithaca, NY 14850, USA.
authors.forename: John G
authors.initials: JG
authors.lastname: Babish
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Clinton J
authors.initials: CJ
authors.lastname: Dahlberg
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Ou
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Keller
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Gao
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Mohan R
authors.initials: MR
authors.lastname: Kaadige
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Holly
authors.initials: H
authors.lastname: Brabazon
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Lamb
authors.affiliation: d Premier Medical Specialists, Stella Maris Obesity Medicine, Tenet Healthcare System, 2315 Dougherty Ferry Rd., Suite 109, St. Louis, MO 63122, USA.|e Washington University School of Medicine, St. Louis, 660 S Euclid Ave, St. Louis, MO 63110, USA.
authors.forename: Hani C
authors.initials: HC
authors.lastname: Soudah
authors.affiliation: c Nature's Sunshine Products, 1655 North Main St., Spanish Fork, UT 84660, USA.
authors.forename: Xiaolan
authors.initials: X
authors.lastname: Kou
authors.affiliation: c Nature's Sunshine Products, 1655 North Main St., Spanish Fork, UT 84660, USA.
authors.forename: Zhe
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: a Bionexus, Ltd., 53 Brown Road, Suite B, Ithaca, NY 14850, USA.
authors.forename: Linda M
authors.initials: LM
authors.lastname: Pacioretty
authors.affiliation: b Hughes Center for Research and Innovation, Nature's Sunshine Products, 2500 Executive Parkway, Lehi, UT 84043, USA.
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Tripp
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000975:Antioxidants / Q000737:chemistry / Q000302:isolation & purification / Q000627:therapeutic use; D002957:Citrus; D004339:Drug Compounding; D004357:Drug Synergism; D050171:Dyslipidemias / Q000175:diagnosis / Q000188:drug therapy / Q000378:metabolism; D008659:Metabolic Diseases / Q000378:metabolism / Q000517:prevention & control; D064209:Phytochemicals / Q000737:chemistry / Q000302:isolation & purification / Q000627:therapeutic use; D010865:Pilot Projects; D010936:Plant Extracts / Q000302:isolation & purification / Q000494:pharmacology / Q000627:therapeutic use; D012307:Risk Factors
chemical_list: D000975:Antioxidants; D064209:Phytochemicals; D010936:Plant Extracts
keywords: HbA1c; LDL oxydées; antioxidant; antioxydant; bergamot; bergamote; cardiometabolic disease; dyslipidemia; dyslipidémie; maladie cardiométabolique; myeloperoxidase; myéloperoxydase; oxidized LDL