CompletedNot Applicable

TirolGESUND: Baseline-controlled Comparison of the Effects of Fasting Dietary Intervention or Smoking Cessation Combined With Exercise in Healthy Female Tyrolean Volunteers Aged 30-60 on Epigenetic and Multi-omic Biomarkers of Health, Ageing, and Disease

Austria156 participantsStarted 2021-04-21

Plain-language summary

The goal of this clinical study is to learn about disease-risk and age-associated changes in DNA methylation patterns associated with disease risk or age in healthy women aged 30-60 in response to health-promoting lifestyle intervention (intermittent fasting or smoking cessation). The main questions the study aims to answer are: * Are the scores of DNA methylation in epigenetic signatures associated with age, women's cancer risk, or risk exposure reduced after 6 months of lifestyle intervention compared to baseline? * What are the dynamics of DNA methylation changes during or following intervention, and do differences in changes between different sample types exist? * Which other biomarkers of health and disease, including metabolic changes, microbiome, clinical, mental, or inflammatory parameters, are altered following intervention? The investigators also aim to explore whether DNA methylation changes are associated with changes in other biomarkers mentioned above. Participants will be allocated to intermittent fasting or smoking cessation based on inclusion criteria. Intermittent fasting encompasses a 16:8 intermittent fasting schedule. Food intake is limited to an 8 h window per day with fasting for the remaining 16 h. Within the intermittent fasting study, participants are randomised to receive a ketogenic supplement (medium-chain triglyceride fibre) or not. Participants in the smoking cessation study will be guided to stop smoking. All participants will receive 1:1 personal coaching throughout the study, and will be provided with an optional exercise programme. All participants will also receive nutritional advice from a professional dietician throughout the study. Participants are invited to donate samples every 2 months for 6 months. Researchers will compare signatures at the start and after 6 months of intervention. Within the intermittent fasting group, researchers will compare effects in individuals that received the ketogenic supplement to those that did not.

Who can participate

Age range30 Years – 60 Years

SexFEMALE

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Inclusion criteria

✓. Women aged 30 to 60
✓. Motivated to change their lifestyle

Exclusion criteria

✕. Relevant underlying conditions:
✕. Current or previous malignant tumour or cancer
✕. Current or previous significant cardiovascular disorder \[participants with elevated blood pressure are allowed to participate as long as it is well controlled under their current medication\]
✕. Current or previous metabolic disorder (e.g., diabetes type I or II) \[in the dietary intervention arm, participants with current hypothyroidism/Morbus Hashimoto will be excluded as the switch to intermittent fasting may require a adjustment of their medication\]
✕. Current or previous psychiatric disorder (e.g., eating disorder, depression)
✕. Current pregnancy or lactation period
✕. Total hysterectomy

What they're measuring

Change from baseline scores of DNA methylation biomarkers of age, disease risk, and exposure

Timeframe: Baseline, Month 6 (per participant)

Trial details

NCT IDNCT05678426

SponsorUniversitaet Innsbruck

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

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