Monitoring of the response of epigenetic and other (multi-omic) biomarkers of ageing, exposure and disease risk to dietary or smoking cessation intervention, with the aim of piloting epigenetic and multi-omic biomarkers as surrogate endpoints for monitoring the prevention of age-associated diseases and cancer in healthy volunteers. Not Applicable
Conditions
Interventions
Allocation to intervention depends on participant baseline characteristics (smoking versus non-smoking and elevated BMI).
The dietary intervention encompasses induction (1 month) and maintenance (5 m
Sponsors
Tirol Kliniken
Universität Innsbruck
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 30 to 60 years 2. Motivated to change their lifestyle Smoking cessation intervention: 3.1. Smoking cessation: =10 cigarettes per day for at least the last five years Dietary intervention: 3.2. Dietary intervention: BMI between 25 and 35 kg/m² NB, should 3a and 3b apply, participants will be allocated to the smoking cessation intervention.
Exclusion criteria
Exclusion criteria: 1. Relevant underlying conditions: 1.1. Current or previous malignant tumour or cancer 1.2. Current or previous significant cardiovascular disorder [participants with elevated blood pressure are allowed to participate as long as it is well controlled under their current medication] 1.3. Current or previous metabolic disorder (e.g., diabetes type I or II) [in the dietary intervention arm, participants with current hypothyroidism/Morbus Hashimoto will be excluded as the switch to intermittent fasting may require a adjustment of their medication] 1.4. Current or previous psychiatric disorder (e.g., eating disorder, depression) 2. Current pregnancy or lactation period 3. Total hysterectomy 4. Known current or previous premalignant lesion of the cervix uteri (CIN2/3) 5. Concurrent participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epigenetic biomarkers of ageing and disease risk are measured at baseline and at 6 months using Illumina Human MethylationEPIC array on the samples, to obtain epigenetic WID disease risk and exposure scores | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Description of general study characteristics relating to participation and dropout: sign-up rate, drop-out rate, compliance 2. Molecular endpoints (1): Evaluation of temporal and tissue-specific dynamics of epigenetic markers of ageing, disease risk, and exposure (e.g. smoking) 3. Molecular endpoints (2): Evaluation of microbial dynamics in fecal and saliva samples, including changes in overall diversity and proportions of certain beneficial or harmful microbial species in fecal microbiome depending on the intervention, distinction of health and lean individuals using microbiome, distinction of smokers and non-smokers using microbiome, shift in dominant types and association with weight loss and potential changes in functional prediction 4. Molecular endpoints (3): Exploratory investigation of metabolomic alterations in urine and saliva over 6 months of intervention. 5. Molecular endpoints (4): Exploratory investigation of cellular and humoral inflammatory dynamics over 6 months of intervention. 6. Clinical endpoints (1): changes in BMI and body composition (muscle, fat, water, abdominal fat composition) (diet arm of the study). 7. Clinical endpoints (2): changes in smoking status (smoking cessation arm of the study). 8. Clinical endpoints (3): Vascular health, including pulse wave velocity, intima-media thickness, and plaque score before and after intervention. 9. Clinical endpoints (4): Physical activity and health, including activity status measured using the international physical activity questionnaire (IPAQ), sports examination (VO2max), and fitnesstracker (daily steps, active minutes, floors climbed); additionally measuring heart rate variability and resting heart rate 10. Clinical endpoints (5): Pulmonary health before and after intervention as measured by spirometry. 10. Psychological endpoints (1): Health-related quality of life (EuroQoL) before and after 6 months of intervention. | — |
Countries
Austria
Outcome results
None listed