Exploring the effects of the washoku diet on gut health in postmenopausal women
The Influence of the Japanese "washoku" Diet on the Composition of the Gut Microbiota and Its Metabolites in Overweight or Obese Postmenopausal Women
This study is testing if following the traditional Japanese washoku diet can improve gut health in postmenopausal women who are overweight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Poznan University of Life Sciences Academic / other |
| Locations | 1 site (Poznan, Wielkopolska) |
| Trial ID | NCT06673199 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of the traditional Japanese washoku diet on the gut microbiota of postmenopausal women. Participants aged 45 to 65, who are at least one year post-menopause and have a BMI over 25, will be randomly assigned to either a washoku diet group or a control group following standard healthy eating guidelines for four weeks. The study will assess various health parameters, including body composition, dietary intake, and biochemical markers, to determine the diet's effects on metabolic health and gut microbiota diversity. Participants will also collect urine and stool samples for further analysis of isoflavones and microbiota composition.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 45 to 65 with a BMI greater than 25.
Not a fit: Patients currently on hormone replacement therapy or with significant metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention to improve metabolic health and gut microbiota in postmenopausal women.
How similar studies have performed: While the specific application of the washoku diet in this context may be novel, similar dietary interventions have shown promise in improving metabolic health in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 45 to 65, * at least one year after natural menopause, * BMI \> 25 kg/m2 * waist circumference \> 80 cm. Exclusion Criteria: * use of hormone replacement therapy; * taking antibiotics or probiotics in the last 6 months from the date of commencement of the scientific experiment, * taking medications regulating carbohydrate or lipid metabolism in the last 4 weeks from the date of commencement of the scientific experiment, * taking medications regulating body weight in the last 3 months from the date of commencement of the scientific experiment, * diseases of the thyroid gland, liver, heart, kidneys, digestive system, anemia, neoplastic diseases, * smoking or alcohol consumption in amounts exceeding 100 g/week.
Where this trial is running
Poznan, Wielkopolska
- Poznań University of Life Sciences — Poznan, Wielkopolska, Poland (Recruiting)
Study contacts
- Study coordinator: Joanna Bajerska, Assoc. Prof.
- Email: Joanna.bajerska@up.poznan.pl
- Phone: 8466056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.