Fermented foods and bone health in vegan women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FERMBONE is an open-label, randomized crossover trial conducted at ETH Zurich and a Prague hospital, enrolling 50 premenopausal vegan women. After a 4-week run-in to standardize gut microbiota, participants receive fermented plant-based foods for 12 weeks and non-fermented foods for 12 weeks in alternating order, separated by an 8-week washout. The study aims to see if fermentation improves mineral bioavailability and bone-related markers via changes in the gut microbiota and short-chain fatty acid production. Outcomes focus on bone health parameters and mineral absorption with dietary interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female, aged 28-43years.
* Body mass index (BMI) between 18.5 and 24.9 kg/m².
* Premenopausal, with regular menstrual cycles. \*
* Adherence to a vegan diet for ≥1 year, confirmed by questionnaire.
* Willingness to consume both fermented and non-fermented plant-based study foods.
* Ability to comply with all study procedures, including run-in, washout, sample collection, and clinic visits.
* Signed written and oral informed consent.

  * Regular menstrual cycles are defined as spontaneous menstrual bleeding occurring every 21-35 days, with cycle-to-cycle variability not exceeding 7-9 days over the prior three months, and bleeding duration of 3-8 days, in the absence of hormonal contraception or endocrine disorders.

Exclusion Criteria:

* Chronic diseases or conditions affecting bone metabolism (e.g., osteoporosis, thyroid disorders, chronic kidney and liver disease, menstrual cycles disorders affecting bone health, conditions associated with malabsorption).
* History of diagnosed eating disorders.
* Chronic inflammatory or gastrointestinal diseases (e.g., IBD, celiac disease).
* Recent antibiotic use (within 3 months prior to screening).
* Use of Vitamin D supplements exceeding 2000 IU/day.
* Abnormal DXA results (T-score ≤ -2.5).
* Pregnancy, intention to become pregnant, or lactation during the course of the study
* Use of hormonal contraceptives.
* Use of medications influencing bone metabolism (e.g., glucocorticoids, antiresorptives).
* BMI \<18.5 or \>24.9 kg/m².
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or anticipated prolonged absence (e.g. extended travel).
* Participation in another clinical study within the last 3 months.
* Known allergy or intolerance to study foods.

Where it's running

• Third Faculty of Medicine
  Prague, Prague, Czechia Recruiting
• Swiss Federal Institute of Technology
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Isabelle Herter-Aeberli, PhD
• Email: isabelle.herter@hest.ethz.ch
• Phone: +41 44 632 74 81

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.