NCT06673199 The Influence of the "washoku" Diet on the Gut Microbiota in Postmenopausal Women
| NCT ID | NCT06673199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Joanna Bajerska |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-16 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-11-16 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Menopause is a special period in a woman's life, when a sudden drop in estrogen levels leads to the cessation of menstrual cycles. Hormonal changes and a decreasing metabolic rate contribute to weight gain and the appearance of numerous metabolic disorders, such as dyslipidemia, impaired glucose tolerance, insulin resistance, hyperinsulinemia, and type 2 diabetes. Currently, effective and inexpensive dietary therapeutic solutions are being sought to improve the health of this group of women. It is suggested that the Japanese washoku diet, which includes products rich in isoflavones, fiber (soy products) and unsaturated omega-3 fatty acids (fish, seaweed), may be a good solution, as it contributes to the regulation of hormonal balance, lowering cholesterol levels, and reducing the risk of insulin resistance. Moreover, the composition of such a diet may also affect the diversity of the intestinal microbiota and the production of its metabolites, such as short-chain fatty acids, and thus contribute to the improvement of patients' health. Taking the above into account, the aim of the study will be to assess the effect of the Japanese washoku diet on the composition of the intestinal microbiota and its metabolites in a group of overweight or obese women after natural menopause. Specific objectives: * Assessment of anthropometric parameters (body weight, height, waist circumference, hip circumference) and body composition and bone density. * Assessment of parameters of carbohydrate metabolism (glucose, insulin concentration), lipid metabolism (total cholesterol (T-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-HDL cholesterol (non-HDL-C) and triglycerides). * Analysis of intestinal microbiota, short-chain fatty acids in the feces of women.
Eligibility 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.
Contact & Investigator
Agata Chmurzyńska, Prof.
STUDY CHAIR
Department of Human Nutrition and Dietetics, Poznań University of Life Sciences
Frequently Asked Questions
Who can join the NCT06673199 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 65 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06673199 currently recruiting?
Yes, NCT06673199 is actively recruiting participants. Contact the research team at Joanna.bajerska@up.poznan.pl for enrollment information.
Where is the NCT06673199 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT06673199 clinical trial?
NCT06673199 is sponsored by Joanna Bajerska. The principal investigator is Agata Chmurzyńska, Prof. at Department of Human Nutrition and Dietetics, Poznań University of Life Sciences. The trial plans to enroll 40 participants.