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Factors Affecting Early Adult Lung Function

Factors Affecting Early Adult Lung Function

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03187158
Acronym
FEAL
Enrollment
500
Registered
2017-06-14
Start date
2017-07-15
Completion date
2019-08-15
Last updated
2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Adult Lung Function, Small Airway Disease, Metabolic Syndrome

Brief summary

Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach.

Detailed description

Introduction: Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach. Sampling: F1 generation of previously registered Indian Birth Cohorts, having collected comprehensive data on maternal exposures, nutrition and anthropometry. Techniques Employed: Spirometry , Forced OscillationTechnique, Anthropometry, Questionnaire, Biochemical analysis of nutritional, immunomodulatory and inflammatory biomarkers.

Interventions

F.O.T. method can be used to assess obstruction in the large and small peripheral airways , Changes in lung volumes will be measured using a digital spirometer . Every participant will be asked to sit straight, seal the mouthpiece completely with their lips, breathe in fully, blow as hard as possible into the mouthpiece, emptying the lungs completely., Whole blood collected on site (20 mL from every participant, for about 23 metabolites) will be separated into cells and serum. A detailed questionnaire assessing respiratory health, demographic data, habits, and environmental exposure has been developed and validated by Chest Research Foundation.

Sponsors

Council of Scientific and Industrial Research, India
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and Women * 18-30 years * Mothers registered in the birth cohort * Able to perform IOS and Spirometry

Exclusion criteria

* Major systemic diseases like cardiac or renal problems * Clinically significant anemia * Bone deformity of chest or spine * muscular weakness * Otherwise unable to participate in spirometry

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary Function Test12-18 monthsTo ascertain whether healthy peak lung function values have been attained
Forced oscillation technique12-18 monthsTo ascertain the magnitude of airway resistance and study the prevalence of small airway disease

Secondary

MeasureTime frameDescription
Serum biochemistry12-18 monthsTo study nutritional, immunological and inflammatory biomarkers correlated with both lung function and metabolic syndrome

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026