Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women: a randomized, double-blind, placebo controlled study

Elizabeth Brink, Veronique Coxam, Simon Robins, Kristiina Wahala, Aedin Cassidy, Francesco Branca, PHYTOS Invest

Research output: Contribution to journalArticle

97 Citations (Scopus)

Abstract

Background: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to hormone replacement therapy for preventing bone loss during the menopausal transition.

Objective: The objective was to investigate whether the consumption of isoflavone-enriched foods for 1 y affects bone mineral density, bone metabolism, and hormonal status in early postmenopausal women.

Design: This was a randomized, double-blind, placebo-controlled, parallel, multicenter trial. Two hundred thirty-seven healthy early postmenopausal women [mean (+/- SD) age of 53 +/- 3 y and time since last menses of 33 +/- 15 mol consumed isoflavone-enriched foods providing a mean daily intake of 110 mg isoflavone aglycones or control products for 1 y while continuing their habitual diet and lifestyle. Outcome measures included bone mineral density of the lumbar spine and total body, markers of bone formation and bone resorption, hormones, isoflavones in plasma and urine, safety variables, and adverse events.

Results: Consumption of isoflavone-enriched products did not alter bone mineral density of the lumbar spine and total body or markers of bone formation and bone resorption. Hormone concentrations did not differ between the isoflavone and control groups. Consumption of isoflavone-enriched products resulted in increased isoflavone concentrations in plasma and urine, whereas control products did not. This finding indicated good compliance with treatment. Subgroup analysis did not support an effect of equol phenotype on bone density. The intervention had no effect on a range of safety variables and reported adverse events.

Conclusion: Consumption of foods containing 110 mg/d of soy isoflavone aglycone equivalents for 1 y did not prevent postmenopausal bone loss and did not affect bone turnover in apparently healthy early postmenopausal white women. This trial was registered at clinicaltrials.gov as NCT00301353.

Original languageEnglish
Pages (from-to)761-770
Number of pages10
JournalThe American Journal of Clinical Nutrition
Volume87
Issue number3
Publication statusPublished - Mar 2008

Keywords

  • isoflavones
  • bone mineral density
  • menopause
  • hormones
  • soy protein
  • premenopausal women
  • controlled-trial
  • phyto-estrogens
  • equol
  • phytoestrogens
  • daidzein
  • Japanese
  • plasma
  • excretion
  • Isoflavones
  • bone mineral density

Cite this

Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women : a randomized, double-blind, placebo controlled study. / Brink, Elizabeth; Coxam, Veronique; Robins, Simon; Wahala, Kristiina; Cassidy, Aedin; Branca, Francesco; PHYTOS Invest.

In: The American Journal of Clinical Nutrition, Vol. 87, No. 3, 03.2008, p. 761-770.

Research output: Contribution to journalArticle

Brink, Elizabeth ; Coxam, Veronique ; Robins, Simon ; Wahala, Kristiina ; Cassidy, Aedin ; Branca, Francesco ; PHYTOS Invest. / Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women : a randomized, double-blind, placebo controlled study. In: The American Journal of Clinical Nutrition. 2008 ; Vol. 87, No. 3. pp. 761-770.
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T1 - Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women

T2 - a randomized, double-blind, placebo controlled study

AU - Brink, Elizabeth

AU - Coxam, Veronique

AU - Robins, Simon

AU - Wahala, Kristiina

AU - Cassidy, Aedin

AU - Branca, Francesco

AU - PHYTOS Invest

PY - 2008/3

Y1 - 2008/3

N2 - Background: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to hormone replacement therapy for preventing bone loss during the menopausal transition. Objective: The objective was to investigate whether the consumption of isoflavone-enriched foods for 1 y affects bone mineral density, bone metabolism, and hormonal status in early postmenopausal women. Design: This was a randomized, double-blind, placebo-controlled, parallel, multicenter trial. Two hundred thirty-seven healthy early postmenopausal women [mean (+/- SD) age of 53 +/- 3 y and time since last menses of 33 +/- 15 mol consumed isoflavone-enriched foods providing a mean daily intake of 110 mg isoflavone aglycones or control products for 1 y while continuing their habitual diet and lifestyle. Outcome measures included bone mineral density of the lumbar spine and total body, markers of bone formation and bone resorption, hormones, isoflavones in plasma and urine, safety variables, and adverse events. Results: Consumption of isoflavone-enriched products did not alter bone mineral density of the lumbar spine and total body or markers of bone formation and bone resorption. Hormone concentrations did not differ between the isoflavone and control groups. Consumption of isoflavone-enriched products resulted in increased isoflavone concentrations in plasma and urine, whereas control products did not. This finding indicated good compliance with treatment. Subgroup analysis did not support an effect of equol phenotype on bone density. The intervention had no effect on a range of safety variables and reported adverse events. Conclusion: Consumption of foods containing 110 mg/d of soy isoflavone aglycone equivalents for 1 y did not prevent postmenopausal bone loss and did not affect bone turnover in apparently healthy early postmenopausal white women. This trial was registered at clinicaltrials.gov as NCT00301353.

AB - Background: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to hormone replacement therapy for preventing bone loss during the menopausal transition. Objective: The objective was to investigate whether the consumption of isoflavone-enriched foods for 1 y affects bone mineral density, bone metabolism, and hormonal status in early postmenopausal women. Design: This was a randomized, double-blind, placebo-controlled, parallel, multicenter trial. Two hundred thirty-seven healthy early postmenopausal women [mean (+/- SD) age of 53 +/- 3 y and time since last menses of 33 +/- 15 mol consumed isoflavone-enriched foods providing a mean daily intake of 110 mg isoflavone aglycones or control products for 1 y while continuing their habitual diet and lifestyle. Outcome measures included bone mineral density of the lumbar spine and total body, markers of bone formation and bone resorption, hormones, isoflavones in plasma and urine, safety variables, and adverse events. Results: Consumption of isoflavone-enriched products did not alter bone mineral density of the lumbar spine and total body or markers of bone formation and bone resorption. Hormone concentrations did not differ between the isoflavone and control groups. Consumption of isoflavone-enriched products resulted in increased isoflavone concentrations in plasma and urine, whereas control products did not. This finding indicated good compliance with treatment. Subgroup analysis did not support an effect of equol phenotype on bone density. The intervention had no effect on a range of safety variables and reported adverse events. Conclusion: Consumption of foods containing 110 mg/d of soy isoflavone aglycone equivalents for 1 y did not prevent postmenopausal bone loss and did not affect bone turnover in apparently healthy early postmenopausal white women. This trial was registered at clinicaltrials.gov as NCT00301353.

KW - isoflavones

KW - bone mineral density

KW - menopause

KW - hormones

KW - soy protein

KW - premenopausal women

KW - controlled-trial

KW - phyto-estrogens

KW - equol

KW - phytoestrogens

KW - daidzein

KW - Japanese

KW - plasma

KW - excretion

KW - Isoflavones

KW - bone mineral density

M3 - Article

VL - 87

SP - 761

EP - 770

JO - The American Journal of Clinical Nutrition

JF - The American Journal of Clinical Nutrition

SN - 0002-9165

IS - 3

ER -