Biomarkers of health in exhaled breath of elderly people- a pilot study

Increasingly biomarkers are being used as health indicators in humans.
Biomarkerstudies focus especially on the monitoring and prediction of health of
specific popiulations or of individuals with specific health risks. Most often
these biomarkers are measured invasively in blood, but recently markers are
also measured non-invasively in exhaled breath. This has advantages, especially
for use in groups such as children or (frail) elderly. Most often breath
analysis uses sampling based on GC-MS, which facilitates off-line sampling but
is prone to measurement error. In a new development - the PTR-QiTOF- exhaled
breath is directly sampled by the analysis equipment which should result in
lower measurement errors. Pilot studies with the PTR-QiTOF have been carried
out by the applicants with healthy participants . Research protocols have been
developed based on the results of these pilot studies, and these will be
applied in future studies such as the one proposed here.

The objective of the study is to determine whether the new PTR-QiTOF method can
successfully differentiate between seniors without specific health complaints
and those who suffer from diabetes mellitus type 2, asthma, or irritable bowel
syndrom. Previous research identified breath biomarkers for diabetes mellitus
type 2, asthma, and irritable bowel syndrome by GC-MS analyses. We hypothesise
that these (and possible additional) biomarkers can be more easily identified
using PTR-QiTOF thus confirming the association between these biomarkers and
these specific health problems in elderly.

The study design will be a within-subject design with repeated measures and a
duration of four months. Four groups of seniors will be included in the study:
seniors with diagnosed type 2 diabetes, asthma, or irritable bowel syndrome and
healthy controls (25 participants per group). Participants visit the lab once
per month for breath analysis and to fill out a short questionnaire (appr. 15
minutes). In addition, participants fill out a digital questionnaire on
disease-specific complaints (type and severity, duration 10 minutes) from home
on a weekly basis.

The risks of this study are very low because participants are only required to
breath a number of times in a tube (6 times 5 seconds per visit). The burden
consists of monthly visits to the lab (20 minutes per visit) over a period of
five months for breath analysis and to fill out a short questionnaire. In
additon, participants fill out a digital questionnaire on disease-specific
complaints on a weekly basis from home.