Trial Outcomes & Findings for Dietary Supplementation With Soy Isoflavones in Asthma (NCT NCT00277446)

Results Overview

Exhaled nitric oxide at baseline (week 0) and at 4 weeks

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

0 and 4 weeks

Results posted on

2011-02-25

Participant Flow

Patients with asthma were recruited from Northwestern's medical clinics and by advertisements in the community.

Patients with asthma were included in the study if they had mild-to-moderate disease not fully controlled on their current treatment.

Participant milestones

Participant milestones
Measure	Soy Isoflavone Supplement This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dietary Supplementation With Soy Isoflavones in Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Soy Isoflavone Supplement n=13 Participants This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
Age Categorical <=18 years	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	15 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants
Age Continuous	37.7 years STANDARD_DEVIATION 12.1 • n=5 Participants
Gender Female	7 participants n=5 Participants
Gender Male	8 participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 and 4 weeks

Population: Per protocol

Exhaled nitric oxide at baseline (week 0) and at 4 weeks

Outcome measures

Outcome measures
Measure	Soy Isoflavone Supplement n=13 Participants This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
Exhaled Nitric Oxide Baseline	67.0 parts per billion (ppb) Standard Deviation 54.6
Exhaled Nitric Oxide 4 weeks	54.8 parts per billion (ppb) Standard Deviation 49.2

SECONDARY outcome

Timeframe: 0 and 4 weeks

Peripheral blood eosinophils were isolated before and after treatment with Novasoy, stimulated with calcium ionophore, and the amount of leukotriene C4 (LTC4) produced was measured by EIA.

Outcome measures

Outcome measures
Measure	Soy Isoflavone Supplement n=13 Participants This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
Eosinophil LTC4 Synthesis Baseline	3.11 ng/ml Standard Deviation 1.63
Eosinophil LTC4 Synthesis 4 weeks	2.07 ng/ml Standard Deviation 1.17

SECONDARY outcome

Timeframe: 0 and 4 weeks

Forced expiratory volume in one second (FEV1) measured as liters/second

Outcome measures

Outcome measures
Measure	Soy Isoflavone Supplement n=13 Participants This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
Forced Expiratory Volume in One Second (FEV1) Baseline	2.59 liters/sec Standard Deviation 0.77
Forced Expiratory Volume in One Second (FEV1) 4 weeks	2.56 liters/sec Standard Deviation 0.92

Adverse Events

Soy Isoflavone Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lewis J. Smith

Northwestern University

Phone: 312-503-0501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place