NCT00244907

Brief Summary

Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. This study will evaluate the effect of soy isoflavones on calcium absorption and bone loss in post menopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

4.3 years

First QC Date

October 25, 2005

Last Update Submit

May 3, 2018

Conditions

OsteoporosisOsteopenia

Keywords

Bone ResorptionPhytoestrogensCalciumGenisteinEquol

Outcome Measures

Primary Outcomes (1)

  • Urinary markers of bone resorption; measured at the end of each treatment phase

    Every 50 days

Secondary Outcomes (1)

  • Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase

    Every 50 days

Study Arms (2)

Genistein vs. Risedronate

ACTIVE COMPARATOR

Healthy post menopausal women who have been dosed with Ca41. Intervention, 100 mg Gensitein from soy protein isolate for 50 days. After a 50 day washout risedronate (Actonel- 5mg per day) for 50 days

Dietary Supplement: Genistein vs Risedronate

Genistein dose and source

ACTIVE COMPARATOR

Healthy post menopausal women will consume 5 products containing varying quantities of genistein from different sources for 50 days each in a randomized order. Each intervention period is separated by a 50 day washout period. Intervention: A) 50 mg genistein from soy protein isolate, B) 100 mg genistein from soy protein isolate, C)50 mg genistein from Novasoy, D) 100 mg genistein from Novasoy, E) 100 ng genistein from 50% Novasoy and 50% soy protein isolate

Dietary Supplement: Genistein vs Risedronate

Interventions

Genistein vs RisedronateDIETARY_SUPPLEMENT

Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)

Also known as: Actonel
Genistein dose and sourceGenistein vs. Risedronate

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 4 years post-menopausal

You may not qualify if:

  • Not currently taking estrogen replacement therapy or undergoing any treatment for osteoporosis
  • Diagnosis of breast cancer
  • Results of mammogram suggesting breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (4)

  • Spence LA, Lipscomb ER, Cadogan J, Martin B, Wastney ME, Peacock M, Weaver CM. The effect of soy protein and soy isoflavones on calcium metabolism in postmenopausal women: a randomized crossover study. Am J Clin Nutr. 2005 Apr;81(4):916-22. doi: 10.1093/ajcn/81.4.916.

    PMID: 15817872BACKGROUND

  • Jackson GS, Weaver C, Elmore D. Use of accelerator mass spectrometry for studies in nutrition. Nutr Res Rev. 2001 Dec;14(2):317-34. doi: 10.1079/NRR200129.

    PMID: 19087429BACKGROUND

  • Pawlowski JW, Martin BR, McCabe GP, McCabe L, Jackson GS, Peacock M, Barnes S, Weaver CM. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):695-703. doi: 10.3945/ajcn.114.093906. Epub 2015 Aug 5.

    PMID: 26245807DERIVED

  • Nakatsu CH, Armstrong A, Clavijo AP, Martin BR, Barnes S, Weaver CM. Fecal bacterial community changes associated with isoflavone metabolites in postmenopausal women after soy bar consumption. PLoS One. 2014 Oct 1;9(10):e108924. doi: 10.1371/journal.pone.0108924. eCollection 2014.

    PMID: 25271941DERIVED

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicBone Resorption

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Connie M. Weaver, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Nutrition Science

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

January 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

US(1)