title: Nutritional supplementation of hop rho iso-alpha acids, berberine, vitamin D₃, and vitamin K₁ produces a favorable bone biomarker profile supporting healthy bone metabolism in postmenopausal women with metabolic syndrome.
abstract: Metabolic syndrome poses additional risk for postmenopausal women who are already at risk for osteoporosis. We hypothesized that a nutritional supplement containing anti-inflammatory phytochemicals and essential bone nutrients would produce a favorable bone biomarker profile in postmenopausal women with metabolic syndrome. In this 14-week, randomized trial, 51 women were instructed to consume a modified Mediterranean-style, low-glycemic-load diet and to engage in aerobic exercise. Those in the intervention arm (n = 25) additionally received 200 mg hop rho iso-alpha acids, 100 mg berberine sulfate trihydrate, 500 IU vitamin D₃, and 500 μg vitamin K₁ twice daily. Forty-five women completed the study. Baseline nutrient intake did not differ between arms. Compared with baseline, the intervention arm exhibited an approximate 25% mean decrease (P < .001) in serum osteocalcin (indicative of bone turnover), whereas the placebo arm exhibited a 21% increase (P = .003). Serum 25-hydroxyvitamin D increased 23% (P = .001) in the intervention arm and decreased 12% (P = .03) in the placebo arm. The between-arm differences for osteocalcin and 25-hydroxyvitamin D were statistically significant. Serum insulin-like growth factor I was statistically increased in both arms, but the between-arm differences were not statistically significant. Subanalysis showed that among those in the highest tertile of baseline insulin-like growth factor I, the intervention arm exhibited a significant increase in amino-terminal propeptide of type I collagen, whereas the placebo arm showed a significant decrease at 14 weeks. Treatment with rho iso-alpha acids, berberine, vitamin D₃, and vitamin K₁ produced a more favorable bone biomarker profile indicative of healthy bone metabolism in postmenopausal women with metabolic syndrome.
authors.affiliation: MetaProteomics, LLC, a subsidiary of Metagenics, Inc., Gig Harbor, WA 98332, USA. josephlamb@metagenics.com
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Lamb
authors.forename: Michael F
authors.initials: MF
authors.lastname: Holick
authors.forename: Robert H
authors.initials: RH
authors.lastname: Lerman
authors.forename: Veera R
authors.initials: VR
authors.lastname: Konda
authors.forename: Deanna M
authors.initials: DM
authors.lastname: Minich
authors.forename: Anuradha
authors.initials: A
authors.lastname: Desai
authors.forename: Tai C
authors.initials: TC
authors.lastname: Chen
authors.forename: Melissa
authors.initials: M
authors.lastname: Austin
authors.forename: Jacob
authors.initials: J
authors.lastname: Kornberg
authors.forename: Jyh-Lurn
authors.initials: JL
authors.lastname: Chang
authors.forename: Alex
authors.initials: A
authors.lastname: Hsi
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Bland
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Tripp
mesh_terms: D000893:Anti-Inflammatory Agents / Q000494:pharmacology / Q000627:therapeutic use; D001599:Berberine / Q000494:pharmacology / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism; D002762:Cholecalciferol / Q000494:pharmacology / Q000627:therapeutic use; D024042:Collagen Type I / Q000097:blood; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D027582:Humulus; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D024821:Metabolic Syndrome / Q000097:blood / Q000150:complications*; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D016037:Single-Blind Method; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D010837:Vitamin K 1 / Q000494:pharmacology / Q000627:therapeutic use; D014815:Vitamins / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D024042:Collagen Type I; D010936:Plant Extracts; D014815:Vitamins; D001599:Berberine; D015675:Osteocalcin; D014807:Vitamin D; D002762:Cholecalciferol; D007334:Insulin-Like Growth Factor I; D010837:Vitamin K 1; C104450:25-hydroxyvitamin D