Modification of Asthma With Soy Isoflavone

NCT00741208 | Completed

• 1 other identifier: 2804
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if dietary supplementation with soy isoflavones in persistent asthma improves airway reactivity as determined by PC20 to methacholine.

Conditions

Asthma

Keywords

asthma; soy isoflavone; genistein; soy

Outcome Measures

Primary Outcomes (1)

• Change in airway reactivity induced by dietary supplementation with soy isoflavones. Airway reactivity will be measured with methacholine bronchoprovocation testing.

  6 weeks

Secondary Outcomes (1)

• Change in FEV1, morning peak flow rate, asthma control, markers of airway hyperreactivity and inflammation including sputum eosinophilia and eosinophilic cationic protein, fraction of expired nitric oxide, and urinary leukotriene.

  6 weeks

Study Arms (2)

1

OTHER

Patients randomized to receive soy isoflavone twice daily for 2 weeks. Patients will cross-over and receive placebo medication for 2 weeks later in the study

Dietary Supplement: Soy Isoflavone

2

OTHER

Patients randomized to receive placebo medication twice daily for 2 weeks. Patients will cross-over and receive soy isoflavone for 2 weeks later in the study

Dietary Supplement: Soy Isoflavone

Interventions

Soy Isoflavone DIETARY_SUPPLEMENT

50mg soy isoflavone supplement consumed twice daily for a total of 100mg of soy isoflavones per day.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Physician diagnosed asthma;
• Positive methacholine bronchoprovocation test (20% fall in FEV1 at less than 8 mg/ml) with the past 3 years;
• Smoking Status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.

You may not qualify if:

• Pulmonary function FEV1\< 70% predicted pre-bronchodilator;
• Other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of COPD, emphysema, or chronic bronchitis;
• Medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months OR use of an investigational treatment within the previous 30 days;
• Drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
• Females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
• Non-adherence: inability or unwillingness to provide informed consent or inability to swallow study medication or inability to perform baseline measurements or completion of fewer than 5 of the 7 days of screening period diary entry or inability to be contacted by telephone;

Sponsors & Collaborators

• Northwestern University: lead
• Respiratory Health Association of Metropolitan Chicago: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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

• Ravi Kalhan, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)