Effect of isoflavones on lipids and bone turnover markers in menopausal women.
OBJECTIVE
The purpose of this analysis was to compare the effects of two dietary supplements derived from red clover to placebo on lipids and bone turnover markers in symptomatic menopausal women.


METHODS
The study was a 12-week randomized, double-blind, placebo-controlled trial. Two hundred and fifty-two menopausal women ages 45-60 years experiencing > or =35 hot flashes per week were randomly assigned to Promensil (82 mg total isoflavones), Rimostil (57.2 mg total isoflavones), or placebo. Primary outcome measures were mean absolute changes for HDL-cholesterol, serum osteocalcin, and urinary N-telopeptide. Secondary outcome measures were mean changes of total cholesterol, LDL-cholesterol, the ratio of HDL- to LDL-cholesterol, and triglycerides.


RESULTS
Ninety-eight percent of participants completed the 12-week protocol. Women taking Rimostil or Promensil compared to those taking placebo had greater mean increases in HDL-cholesterol; however, this change was small in magnitude (<2 mg/dl) and did not reach significance. There was a significant decrease in triglyceride levels among women taking Rimostil (14.4 mg/dl, P = 0.02) or Promensil (10.9 mg/dl, P = 0.05) compared to those taking placebo. The decrease was primarily among women with elevated baseline triglyceride levels (P for interaction = 0.009). There were no differences in mean changes of total cholesterol, LDL-cholesterol, or the ratio of HDL- to LDL-cholesterol among treatment groups. There were no statistically significant differences among treatment groups for bone turnover markers.


CONCLUSIONS
Compared with placebo, both of the supplements containing isoflavones decrease levels of triglycerides in symptomatic menopausal women; however, this effect is small in magnitude.
Schult
Tamara M Knudson
TM
Center for Chronic Disease Outcomes Research, Minneapolis VA Medical Center, MN 55417, USA. tamara.schult@med.va.gov
Ensrud
Kristine E
KE
Blackwell
Terri
T
Ettinger
Bruce
B
Wallace
Robert
R
Tice
Jeffrey A
JA
D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003094:Collagen / Q000652:urine; D024042:Collagen Type I; D019587:Dietary Supplements; D005260:Female; D005500:Follow-Up Studies; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007529:Isoflavones / Q000494:pharmacology / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008593:Menopause / Q000187:drug effects; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010455:Peptides / Q000652:urine; D010936:Plant Extracts / Q000627:therapeutic use; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D024042:Collagen Type I; D007529:Isoflavones; D008055:Lipids; D010455:Peptides; D010936:Plant Extracts; C487928:Promensil; D014280:Triglycerides; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; D003094:Collagen