L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics

In people who develop asthma after the age of 12 and who are also overweigh, there can be an increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when compared to normal weight asthmatics. Certain factors are more abundant in the blood of individuals who are obese. One such factor is derived from the metabolism of an amino acid found in your diet, which is known as L-arginine (Amino acids are most commonly known as the building blocks of proteins, the same as the proteins found in food). This factor is called asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to the health of subjects with asthma. The balance between L-arginine and ADMA plays an important role in producing nitric oxide (NO) in the airways. NO is normally produced in the lung and plays a major role in maintaining airways open and functioning normally. Our research has shown that in subjects with asthma who are overweight and developed asthma later in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are asking participants in this study to take L-citrulline, which is converted to L-arginine by your body, as a supplement for a period of one week. We anticipate that L-citrulline will restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA

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Key information

Conditions

Asthma Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asthma Institute, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female patients, 18-75 yrs old, from all racial/ethnic backgrounds
Diagnosis of asthma for >1 yr
BMI ≥ 30
Baseline pre-bronchodilator FEV1 between 60 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol
Smoking history <20 pack years and no smoking in the last year
Able to identify age of asthma onset

Exclusion criteria

Respiratory tract infection within the last 4 weeks;
Oral CS burst within the last 4 weeks or regular systemic CS use
Hospitalization within the last 3 months
ER visit within the 4 weeks
Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, diabetes
Current smoking or within the previous 12 months
Current use of statins for the past 30 days (Statins lower ADMA levels)
Pregnancy
Intolerance or allergy to L-arginine or L-citrulline
Phosphodiesterase inhibitors
Taking oral nitrates

Treatment and study plan

L-citrulline

Dietary Supplement

Patients will take 3-gr of L-citrulline/day for 7 days

Other names: L-citrulline 3 gr efervescent powder

Primary outcomes

Exhaled nitric oxide

Time frame: 1 week

Patients will be randomized to 1 week of 3 g of L-citrulline/day vs matching placebo, The outcome is the pre to post intervention change in exhaled NO

Secondary outcomes

Sputum and plasma L-arginine/ADMA levels

Time frame: 1 week

This outcome compares the pre to post L-citrulline supplementation changes in sputum and plasma L-arginine/ADMA

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: SANDIA

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Oct 29, 2012
Registry last updated: Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed