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The Study of Soy Isoflavones in Asthma

2014-08-27 03:16:33 | BioPortfolio

Summary

The trial is designed to study the effects of soy supplements on asthma control.

Description

Asthma is a common disease that has a major impact on morbidity and health care costs. Although the prevalence and severity of asthma have increased over the last several decades, the specific causes remain unknown. One possible mechanism is a change in diet. Yet, epidemiological and interventional studies designed to identify a key nutrient or antioxidant vitamin that may be responsible for the increase in disease severity have produced inconsistent results. A recent pilot study showed a soy isoflavone supplement reduces exhaled nitric oxide (FeNO) and ex vivo LTC4 synthesis in patients with inadequately controlled asthma. This clinical trial is designed to test the novel hypothesis that dietary supplementation with soy isoflavones is an effective treatment in patients with poorly controlled asthma. The study will include 380 patients with low dietary soy intake, 12 years of age or older, who are taking either inhaled corticosteroids or leukotriene modifiers and have inadequately controlled asthma. Participants will be randomly assigned to treatment with either a soy isoflavone supplement (containing genistein, daidzein and glycitein; 100 mg daily of the glycoside forms) or placebo for six months. The results of this trial will increase understanding of the role of diet in asthma; could identify a novel, safe and relatively inexpensive treatment for patients with asthma; and potentially will have a substantial impact on public health in the United States.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Asthma

Intervention

Soy isoflavone supplement, Placebo

Location

University of Arizona
Tucson
Arizona
United States
85724

Status

Recruiting

Source

American Lung Association Asthma Clinical Research Centers

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:33-0400

Clinical Trials [2024 Associated Clinical Trials listed on BioPortfolio]

Modification of Asthma With Soy Isoflavone

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.

Dietary Supplementation With Soy Isoflavones in Asthma

An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isofl...

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In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with recurrent asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a place...

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The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will ...

PubMed Articles [2333 Associated PubMed Articles listed on BioPortfolio]

Increasing effort without noticing: A randomized controlled pilot study about the ergogenic placebo effect in endurance athletes and the role of supplement salience.

Previous research shows that endurance performance can be enhanced by placebo ergogenic aids. This study investigates the ergogenic placebo response, which we define as an increase in objective and ph...

Alfred William (Bill) Frankland.

First double- blind, placebo - controlled trials in allergy: grass pollen immunotherapy proved effective. but bacterial vaccines lacked efficacy in asthma. First Secretary of BSACI. Instituted the UK ...

Isoflavone supplementation plus combined aerobic and resistance exercise do not change phase angle values in postmenopausal women: A randomized placebo-controlled clinical trial.

The aim of this study was to evaluate the effect of isoflavone supplementation associated with combined exercise protocol on phase angle (PhA) values in postmenopausal women.

Anti-IL5 in Mild Asthma Alters Rhinovirus-Induced Macrophage, B Cell and Neutrophil Responses (MATERIAL): A Placebo-Controlled, Double-Blind Study.

Eosinophils drive pathophysiology in stable and exacerbating eosinophilic asthma and therefore treatment is focused on the reduction of eosinophil numbers. Mepolizumab, a humanized monoclonal antibody...

Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma.

Background Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. We assessed its efficacy and safety in patients wi...

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Asthma attacks caused, triggered, or exacerbated by OCCUPATIONAL EXPOSURE.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A genus of filamentous CYANOBACTERIA found in most lakes and ponds. It has been used as a nutritional supplement particularly due to its high protein content.

A species of green microalgae in the family Chlorellaceae. It is used as a model organism for PHOTOSYNTHESIS, and as a food supplement (DIETARY SUPPLEMENTS).

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