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

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Washoku diet (Dietary Supplement) — The Washoku diet will consist of following the principles of a healthy eating plate, which will be supplemented with elements of the Washoku diet (30g of roasted black soybeans and 5g of wakame). Food products will be given to women…

Who can join

Women only · Ages 45 Years to 65 Years

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-11-16
• Primary completion: 2025-12-31
• Last update posted: 2024-11-14
• First posted: 2024-11-04

Sponsor & contact

Lead sponsor: Joanna Bajerska (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in composition of the intestinal microbiota (Week 0 (pre-intervention) and week 4 (post-intervention))
  Participants will be asked to provide stool samples at each scheduled meeting. Detailed instructions on sample collection and transport will be provided by the people conducting the study, and participants will receive containers containing preservative liquid. Bacterial DNA will be isolated from the provided stool samples using the QIAmp Fast DNA Stool Mini Kit. Then, the DNA will be properly…
• Change in body weight (Week 0 (pre-intervention) and week 4 (post-intervention))
  Body weight measurement in a standing position, without shoes, in light clothing, on an electronic scale with an accuracy of 0.1 kg.
• Change in body composition (Week 0 (pre-intervention), week 4, week 8 and week 12 (post-intervention))
  Body composition will be measured using dual-energy X-ray absorptiometry (DXA) as a method that uses the phenomenon of weakening the beam of ionizing radiation passing through tissues of various densities. This method is safe and non-invasive. The mass of adipose tissue, including visceral fat tissue, the mass of lean tissue are measured. (expressed in the same unit - kilograms)
• Change in circumferences (Week 0 (pre-intervention) and week 4 (post-intervention))
  Waist and hip measurements will be taken using an elastic tape. Waist circumference measurement - the tape is placed horizontally or slightly obliquely halfway between the lower edge of the ribs and the upper crest of the ilium. Measurement performed during apnea.
• Change in lipid profile (Week 0 (pre-intervention) and week 4 (post-intervention))
  Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Total cholesterol (T-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglycerides concentrations will…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.