Fermented Foods and Bone Health: Investigating the Gut-Bone Axis in Premenopausal Vegan Women

NCT07645885 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-12

No results posted yet for this study

Summary

Plant-based diets are increasingly adopted for health and environmental reasons, but they are associated with lower bone mineral density, higher fracture risk, and elevated bone turnover markers, particularly in women. These effects are partly explained by lower intakes of calcium and zinc, and higher concentrations of phytates and oxalates, substances that inhibit mineral absorption from plant foods. Evidence-based dietary strategies to support bone health in vegan populations beyond supplementation remain limited.

Fermented plant-based foods may help address this gap through two complementary mechanisms: first, by delivering live microorganisms that beneficially modulate gut microbiota and promote the production of short-chain fatty acids, which support mineral absorption and reduce bone resorption, and second, by reducing antinutritional factors such as phytates during microbial fermentation, thereby improving mineral bioavailability.

This study investigates whether the daily consumption of fermented plant-based foods, specifically lacto-fermented vegetables, calcium-fortified plant-based yogurt alternatives with live cultures, and Rhizopus-fermented tempeh, reduces bone resorption and improves calcium metabolism in premenopausal women following a vegan diet. Participants will follow each dietary condition (fermented or matched non-fermented control foods) for 12 weeks in randomized order, separated by an 8-week washout period. Blood, urine, and stool samples are collected at each study visit to assess bone turnover markers, gut microbiota composition, short-chain fatty acid production, inflammatory markers, and a range of metabolic and nutritional parameters.

Conditions

  • Bone
  • Bone Health

Interventions

OTHER

Fermented Plant-Based Foods

Daily consumption of three categories of fermented plant-based foods for 12 weeks: lacto-fermented vegetables, fermented plant-based yogurt alternatives with live cultures and calcium fortification, and Rhizopus-fermented tempeh. Minimum combined weekly target: 14 portions.

OTHER

Non-Fermented Plant-Based Foods

Daily consumption of non-fermented plant-based equivalents for 12 weeks, matched to the intervention arm for portion size, energy, protein, and calcium content: non-fermented calcium-fortified plant-based milk, fresh raw vegetables, and cooked non-fermented legumes.

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER
  • Philhuman Foundation

    collaborator UNKNOWN
  • Czech Science Foundation

    collaborator OTHER_GOV
  • Charles University, Czech Republic

    collaborator OTHER
  • Isabelle Herter-Aeberli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
28 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Czechia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645885 on ClinicalTrials.gov