Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women

NCT00491595 | Completed Phase 1 DMC

• 1 other identifier: NCI-N01-CN-75035
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are compounds that occur naturally in soybeans and can be extracted to put in to capsule form or add to foods. The capsule formulation being used in this study is considered an investigational drug. This research is being done because many scientists believe that isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have been safely consumed in foods for centuries, we need to know if these soy components are safe to take in higher doses when they are extracted from foods and provided in a supplement form. We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein and glycitein.

Conditions

Drug Toxicity

Keywords

Soy isoflavones; Genotoxicity; Apoptosis; Estrogenic effects

Outcome Measures

Primary Outcomes (1)

• DNA damage, apoptosis, estrogenic effects and changes in gene expression

  112 days

Interventions

High Dose Soy isoflavones DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance status 0, 1, or 2 on ECOG scale
• Acceptable hematopoietic, hepatic, and renal function (WBC≥3500 µL, platelet count ≥ 100,000/ml, serum creatinine \< 2.0 mg/dl, serum bilirubin ≤ 2.0 mg/dl, transaminases \< two times normal limits)
• Post-menopausal status - FSH level \> 27 mIU/ml, no spontaneous bleeding \> 1 year
• Normal mammogram within the last 13 months
• Normal Papanicolaou Test within the last 13 months

You may not qualify if:

• Serious intercurrent medical illnesses or history of seizure
• Significant cardiac disease (New York Heart Association Class III or IV)
• Abnormalities on the physical examination screen including significant abnormality of the heart, lungs, liver, spleen, or other abdominal organs, or neurologic abnormality Abnormalities on the biochemical screen that could be metabolically significant
• Individuals with intermediate equol values (\> 10 ug/L to \< 20 ug/L) on soy challenge
• Use of antibiotics within the last 3 months
• Use of hormone/estrogen therapy or SERMs within the last 3 months
• Abnormal thyroid or endocrine function tests; or current use of thyroid medication
• BMI at or above 35
• History of complete hysterectomy or oophorectomy
• High risk of breast cancer (5-year risk of \>1.9%) based on NCI's Breast Cancer Risk Assessment Tool
• A history of a malignancy active or initially diagnosed within 2 years other than curatively treated non-melanoma carcinoma of the skin
• History of substance abuse or addiction
• Alcohol intake of greater than 2 drinks/day or 14 drinks/week
• Tobacco use
• Diets containing more than estimated intake of 20 mg genistein/day or 40mg isoflavone/day AND unwilling/unable to reduce soy intake to below this level during the study period

Sponsors & Collaborators

• University of North Carolina: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Steven H Zeisel, MD, PhD

  UNC at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: March 1, 2004
• Study Completion: July 1, 2005
• Last Updated: June 26, 2007

Record last verified: 2007-06