Early Adult Lung FunctionFEALNCT03187158
Factors Affecting Early Adult Lung Function
An observational study of Early Adult Lung Function and Small Airway Disease, run by Council of Scientific and Industrial Research, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Adult Lung Function, Small Airway Disease, Metabolic Syndrome
- What is being tested?
- Forced Oscillation Technique
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jul 2017to 15 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Both birth cohorts,will be instrumental in understanding the link between intergenerational nutrition, early life exposures metabolism and lung health, particularly in rapidly developing lungs. Subjects have already been enrolled in the cohort. Complete datasets of offspring, now aged around 18-30 years, are available through this study, starting from pre-natal environment.
Who may be able to join
- Men and Women
- 18-30 years
- Mothers registered in the birth cohort
- Able to perform IOS and Spirometry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology
New Delhi, 110007
About this study
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.
Read the 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.
- Being tested
- Forced Oscillation Technique
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced Oscillation TechniqueDiagnostic test
Also called Spirometry, Questionnaire, Biochemical analysis of nutritional, immunological and inflammatory biomarkers
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Forced Oscillation Technique | |
| 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. Receives: Diagnostic Test: Forced Oscillation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test
To ascertain whether healthy peak lung function values have been attained
Measured: 12-18 months
Forced oscillation technique
To ascertain the magnitude of airway resistance and study the prevalence of small airway disease
Measured: 12-18 months
Secondary outcomes (1)
Serum biochemistry
To study nutritional, immunological and inflammatory biomarkers correlated with both lung function and metabolic syndrome
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jul 2017 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Adult Lung FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Council of Scientific and Industrial Research, India
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187158
- Sponsor's protocol ID
- MLP5502
- Acronym
- FEAL
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data sets and/or documents to be shared : Lung function data, biomarker data, retrospective maternal anthropometry data will be shared as a complete dataset, but with a participant ID which will be delinked from actual participant identity. The ID will only be linked to the participant in the event that an abnormality is detected and the participant may require intervention. Data will be shared via a common excel sheet available to all investigators.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Early Adult Lung Function
- ClinicalTrials.gov ID
- NCT03187158
- Acronym / sponsor ID
- FEAL / MLP5502
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Council of Scientific and Industrial Research, IndiaOther government
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pune Maternal Nutrition Cohort | – | Diagnostic Test: Forced Oscillation TechniqueStudy 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 | – | Diagnostic Test: Forced Oscillation TechniqueStudy 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Both birth cohorts,will be instrumental in understanding the link between intergenerational nutrition, early life exposures metabolism and lung health, particularly in rapidly developing lungs. Subjects have already been enrolled in the cohort. Complete datasets of offspring, now aged around 18-30 years, are available through this study, starting from pre-natal environment.
Key inclusion criteria (4 listed)
- Men and Women
- 18-30 years
- Mothers registered in the birth cohort
- Able to perform IOS and Spirometry
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced Oscillation TechniqueAlso: Spirometry, Questionnaire, Biochemical analysis of nutritional, immunological and inflammatory biomarkersF.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. | Diagnostic test | New Delhi Birth Cohort, Pune Maternal Nutrition Cohort |
Primary outcome
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
1 secondary outcome
Serum biochemistry
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: Yes. Participant data sets and/or documents to be shared : Lung function data, biomarker data, retrospective maternal anthropometry data will be shared as a complete dataset, but with a participant ID which will be delinked from actual participant identity. The ID will only be linked to the participant in the event that an abnormality is detected and the participant may require intervention. Data will be shared via a common excel sheet available to all investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Adult Lung Function and Small Airway Disease, run by Council of Scientific and Industrial Research, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (time frame: 12-18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.