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

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.

Conditions

• Healthy
• Healthy Lifestyle
• Smoking Cessation
• Intermittent Fasting

Interventions

BEHAVIORAL

Smoking cessation

Smoking cessation encompasses three guided smoking cessation group therapy sessions (6-12 participants per session) followed by smoking cessation (occuring in the second session) for 6 months. Participants receive an optional exercise programme and motivational coaching over the duration of the study.

BEHAVIORAL

Intermittent fasting

The dietary intervention encompasses induction (1 month) and maintenance (5 months) of a 16:8 intermittent fasting regime (time restricted eating to 8 h a day, fasting for remaining 16 h). During the introductory month, participants will only maintain a 14:10 intermittent fasting regime. Participants receive an optional exercise programme and motivational coaching over the duration of the study.

BEHAVIORAL

Intermittent fasting with ketogenic supplement

The dietary intervention encompasses induction (1 month) and maintenance (5 months) of a 16:8 intermittent fasting regime (time restricted eating to 8 h a day, fasting for remaining 16 h). During the introductory month, participants will only maintain a 14:10 intermittent fasting regime. Participants receive a ketogenic supplement, medium-chain triglyceride fiber, to use daily. Participants receive an optional exercise programme and motivational coaching over the duration of the study.

Sponsors & Collaborators

• Tirol Kiniken GmbH

  collaborator OTHER

• Universitaet Innsbruck

  lead OTHER

Principal Investigators

• Martin Widschwendter, MD · Universitaet Innsbruck

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-21

Primary Completion

2022-08-31

Completion

2025-09-04

Countries

• Austria

Study Locations