Factors Affecting Early Adult Lung Function

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: July 15, 2019

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

  • Diagnostic Test: Forced Oscillation Technique
    • 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.

Arms, Groups and Cohorts

  • Pune Maternal Nutrition Cohort
    • Study has been planned on the F1 generation of the mothers recruited under the PMNS study at Diabetes Unit, KEM-Pune. Data on maternal nutrition, exposures and anthropometry have been collected, in the F1 generation. This study will be adding cross sectional lung function measurement, biochemical analyses for nutritional, immunological and inflammatory biomarkers.
  • New Delhi Birth Cohort
    • Study has been planned on the F1 generation of the mothers recruited under the New Delhi Birth Cohort in New Delhi, India. Data on maternal nutrition, exposures and anthropometry have been collected, in the F1 generation, the study will be adding cross sectional lung function measurement, biochemical analyses for nutritional, immunological and inflammatory biomarkers.

Clinical Trial Outcome Measures

Primary Measures

  • Pulmonary Function Test
    • Time Frame: 12-18 months
    • To ascertain whether healthy peak lung function values have been attained
  • Forced oscillation technique
    • Time Frame: 12-18 months
    • To ascertain the magnitude of airway resistance and study the prevalence of small airway disease

Secondary Measures

  • Serum biochemistry
    • Time Frame: 12-18 months
    • To study nutritional, immunological and inflammatory biomarkers correlated with both lung function and metabolic syndrome

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Council of Scientific and Industrial Research, India
  • Provider of Information About this Clinical Study
    • Sponsor

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