NCT06673199Completed
The Influence of the "Washoku" Diet on the Gut Microbiota 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
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 29 Oct 2024
- Start date
- 16 Nov 2024
- Primary completion date
- 31 May 2025
- Lead sponsor
- Joanna Bajerska
- Diseases
- Obesity
- NCT number
- NCT06673199
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 16 Nov 2024 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of hormone replacement therapy;
- 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,
Other illness
- diseases of the thyroid gland, liver, heart, kidneys, digestive system, anemia, neoplastic diseases,
Other
- taking antibiotics or probiotics in the last 6 months from the date of commencement of the scientific experiment,
- smoking or alcohol consumption in amounts exceeding 100 g/week.
Who the study is looking for
- age 45 to 65,
- at least one year after natural menopause,
- BMI \> 25 kg/m2
- waist circumference \> 80 cm.
Age in the registry: 45 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Poznań University of Life Sciences Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.