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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06673199). This is a study registration, not published results. Lead sponsor: Joanna Bajerska. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 35 participants (ACTUAL). Conditions: Menopause. Interventions: DIETARY_SUPPLEMENT: Washoku diet. Primary outcome measures: Change in composition of the intestinal microbiota , Week 0 (pre-intervention) and week 4 (post-intervention); Change in body weight , Week 0 (pre-intervention) and week 4 (post-intervention); Change in body composition , Week 0 (pre-intervention), week 4, week 8 and week 12 (post-intervention); Change in circumferences , Week 0 (pre-intervention) and week 4 (post-intervention); Change in lipid profile , Week 0 (pre-intervention) and week 4 (post-intervention); Change in glucose metabolism , Week 0 (pre-intervention) and week 4 (post-intervention); Change in urinary isoflavone content , Week 0 (pre-intervention) and week 4 (post-intervention); Change in urine pH , Week 0 (pre-intervention) and week 4 (post-intervention); Change in urine creatinine , Week 0 (pre-intervention) and week 4 (post-intervention); Change in urine sodium and magnesium , Week 0 (pre-intervention) and week 4 (post-intervention). 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.