NCT00043745

Brief Summary

This study will provide valuable data on whether soy isoflavones impact bone loss in postmenopausal women. The study will help clarify potential mechanisms and contribute to our understanding of isoflavones as an alternative to traditional hormone therapy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2002

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

5.1 years

First QC Date

August 13, 2002

Last Update Submit

February 6, 2013

Conditions

OsteopeniaOsteoporosis

Keywords

soyisoflavonesalternative hormone therapybone loss

Outcome Measures

Primary Outcomes (1)

  • Lumbar spine bone mineral density

    Year 3

Secondary Outcomes (1)

  • Proximal femur bone mineral density

    Year 3

Study Arms (3)

1

EXPERIMENTAL

Participants will receive moderate dose soy isoflavone (80 mg/day) tablets, extracted from soy protein

Dietary Supplement: Soy isoflavones

2

EXPERIMENTAL

Participants will receive high dose soy isoflavone (120 mg/day) tablets, extracted from soy protein

Dietary Supplement: Soy isoflavones

3

PLACEBO COMPARATOR

Participants will receive soy extract devoid of isoflavones to serve as placebo

Dietary Supplement: Extract tablets

Interventions

Soy isoflavonesDIETARY_SUPPLEMENT

Soy isoflavones extracted from soy protein, compressed into tablets; three tablets taken daily

12
Extract tabletsDIETARY_SUPPLEMENT

Extract from soy protein, but devoid of isoflavones; three tablets taken once daily

3

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early postmenopausal (i.e., no menses during past 12 months) women, with an upper limit of 10 years since their last cycle
  • Natural menopause (i.e., no hysterectomies or oophorectomies)
  • Body mass index (BMI) \> 20 and \< 30

You may not qualify if:

  • Current or previous (within 12 months) use of hormone replacement therapy, hormonal contraceptives, estrogens, or progestogens
  • Current use of pharmacologic agents, such as selective estrogen-receptor modulators (SERMs) (e.g., raloxifene or tamoxifen) or anti-resorptive agents (e.g., alendronate or calcitonin), herbal therapies that may have estrogenic effects (e.g., herbimycin, tryphostins), or cigarettes
  • Strict vegans (but will include lacto-ovo-, lacto-, and ovo-vegetarians)
  • Metabolic bone disease, renal disease, history of urolithiasis, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease, or other chronic diseases
  • First-degree relative with breast cancer
  • Lumbar spine BMD \>= -1.5 standard deviations (SD) below mean (high-risk for osteoporosis) and BMD \>= +1.0 SD above mean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

USDA/ARS/WHNRC University of California-Davis

Davis, California, 95616, United States

Location

Iowa State University

Ames, Iowa, 50011, United States

Location

Related Publications (3)

  • Alekel DL, Genschel U, Koehler KJ, Hofmann H, Van Loan MD, Beer BS, Hanson LN, Peterson CT, Kurzer MS. Soy Isoflavones for Reducing Bone Loss Study: effects of a 3-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women. Menopause. 2015 Feb;22(2):185-97. doi: 10.1097/GME.0000000000000280.

    PMID: 25003624DERIVED

  • Matvienko OA, Alekel DL, Genschel U, Ritland L, Van Loan MD, Koehler KJ. Appetitive hormones, but not isoflavone tablets, influence overall and central adiposity in healthy postmenopausal women. Menopause. 2010 May-Jun;17(3):594-601. doi: 10.1097/gme.0b013e3181c92134.

    PMID: 20142790DERIVED

  • Alekel DL, Van Loan MD, Koehler KJ, Hanson LN, Stewart JW, Hanson KB, Kurzer MS, Peterson CT. The soy isoflavones for reducing bone loss (SIRBL) study: a 3-y randomized controlled trial in postmenopausal women. Am J Clin Nutr. 2010 Jan;91(1):218-30. doi: 10.3945/ajcn.2009.28306. Epub 2009 Nov 11.

    PMID: 19906801DERIVED

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • D. Lee Alekel, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2002

First Posted

August 14, 2002

Study Start

March 1, 2003

Primary Completion

April 1, 2008

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(2)