The Influence of the "washoku" Diet on the Gut Microbiota in Postmenopausal Women

Recruiting now · Not applicable

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT06673199

Run by

Joanna Bajerska

People needed

40

Starts

2024-11-16

Expected to finish

2027-11-12

Last updated by the study team

2024-11-14

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• age 45 to 65,
• at least one year after natural menopause,
• BMI > 25 kg/m2
• waist circumference > 80 cm.

You may not qualify if…

• 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 it is running

• Poznań University of Life Sciences — Poznan, Wielkopolska, Poland (enrolling)

Full record on ClinicalTrials.gov

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