MenopauseNCT06673199
The Influence of the "Washoku" Diet on the Gut Microbiota in Postmenopausal Women
A study testing Washoku diet in people with Menopause, run by Joanna Bajerska at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Washoku diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePoland
- Study dates
- 16 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 45 to 65,
- at least one year after natural menopause,
- BMI > 25 kg/m2
- waist circumference > 80 cm.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Japanese "Washoku" Diet on the Composition of the Gut Microbiota and Its Metabolites in Overweight or Obese Postmenopausal Women
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.
Read the detailed description
Women who meet the criteria for inclusion in the study for a period of 4 weeks will be randomly assigned to one of two groups: 1. The intervention group will follow the principles of the healthy eating plate, which will be supplemented with elements of the washoku diet (30 g of roasted black soybeans and 5 g of wakame); 2. The control group will be covered only by the principles of the healthy eating plate.
All participants will receive a brochure with information on the recommended portion sizes of individual product groups in the daily diet, recipes for dishes based on roasted black soybeans and wakame. Before and after the study, in addition to anthropometric measurements (body weight, waist circumference, hip circumference), body composition and bone mineral density, an assessment of the diet (using a semi-quantitative questionnaire of food frequency, as well as the current recording method from the last 4 days) and the level of physical activity will be carried out. Additionally, the women will be asked to collect a daily portion of urine to assess the concentration of soy isoflavones and to determine the content of sodium, potassium and magnesium. Women will also have their blood (18 ml) collected to assess selected biochemical parameters (glucose, insulin, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-HDL cholesterol (non-HDL-C) and triglycerides). A stool sample will also be collected to assess the composition of the intestinal microbiota and its metabolites, i.e. short-chain fatty acids. Recruitment will take place via social networking sites, i.e. Facebook.
The following specific analyses were planned:
- Assessment of anthropometric parameters (height, body weight, hips and waist circumference)
- Analysis of body composition and bone mineral density
- Assessment of nutritional status (selected metabolic parameters such as glucose metabolism (glucose, insulin concentration), lipid metabolism (total cholesterol (T-C), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), non-HDL cholesterol (non-HDL-C) and triglycerides).
- Assessment of dietary habits (a semi-quantitative questionnaire on the frequency of food intake, additionally supplemented by the current recording method from the last 4 days.)
- Assessment of intestinal microbiota composition
- Assessment of fecal short-chain fatty acid concentration
- Assessment of urine soy isoflavones concentration
Normality of the obtained data distribution will be tested using the Shapiro-Wilk test. The Kruskal-Wallis test then will be used for nonnormally distributed data and the Tukey HSD test will be used for normally distributed data. A p value of less than 0.05 was considered statistically. The microbiota composition will be analyzed using RStudio (R version 4.0.3 (2020-10-10)) with packages including phyloseq, microbiome, and vegan. Taxa will be filtered by removing all those not assigned to any phylum. Only taxa with abundances over 0.25% in at least one sample will left in the dataset. All analyses of gut microbiota composition will be performed on the basis of the relative abundances (RA) of the OTUs (Operational Taxonomic Units).
The data collected in the planned studies will include the results of measurements and their statistical analyzes. All data will be collected directly by team members and coded. Detailed instructions on data collection will be prepared by the team leader and each member will need to read and receive appropriate training. All biochemical and anthropometric measurements will be performed in at least two repetitions and will be checked by another team member. All used specialized equipment will be properly calibrated before each use (scale, body composition analyzer, Nanodrop spectrophotometer).
- Conditions
- Menopause
- Being tested
- Washoku diet
- Keywords
- menopause, microbiota, isoflavones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Washoku dietDietary 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 on the day of the first meeting. The Washoku diet will be used for 7 days a week for a period of 1 month (4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Washoku diet | Experimental | Participants assigned to the washoku group will be introduced to the principles of a healthy eating plate, which will be supplemented with elements of the washoku diet (30 g of roasted black soybeans and 5 g of wakame). Receives: Dietary Supplement: Washoku diet |
| Control group | No intervention | Participants assigned to the control group will receive only dietary recommendations consistent with the healthy eating plate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composition of the intestinal microbiota
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 secured and sent to an external company, Genomed S.A. (Warsaw, Poland), in which the assessment of microbiota will be carried out by metagenomic 16s rRNA sequencing using the V3-V4 region. Then, a bioinformatics analysis will be performed in the R environment using packages such as phyloseq, vegan, microbiome.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in body weight
Body weight measurement in a standing position, without shoes, in light clothing, on an electronic scale with an accuracy of 0.1 kg.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in body composition
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)
Measured: Week 0 (pre-intervention), week 4, week 8 and week 12 (post-intervention)
Change in circumferences
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.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in lipid profile
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 be determined by a certified external laboratory. The nonHDL-C parameter will be calculated using the formula: nonHDL-C = T-C - HDL-C. (expressed in the same unit - mg/dl or mmol/l).
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in glucose metabolism
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. Insulin concentration will be performed using the ELISA enzyme-linked immunosorbent assay, while glucose will be determined by a certified external laboratory. (expressed in the same unit - mg/dl or mmol/l).
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in urinary isoflavone content
Soy isoflavone concentrations will be assessed in a 24-hour urine sample provided by women before and after the study using high-performance liquid chromatography.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in urine pH
pH will be assessed in a 24-hour urine sample provided by women before and after the study using litmus paper or laboratory pH meter.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in urine creatinine
Creatinine concentration will be assessed in a 24-hour urine sample provided by women before and after the study using high-performance liquid chromatography.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in urine sodium and magnesium
Sodium and magnesium concentrations will be assessed in a 24-hour urine sample provided by women before and after the study using automatic electrolyte analyzer.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Secondary outcomes (4)
Changes in results of nutrition assessment
Nutrition assessment will be carried out using food frequency questionnaire (FFQ) which concerns the frequency of consumption of 62 food groups in the last 12 months. The obtained data (frequency of food consumption rated from 1 to 6) will then be transformed into semi-quantitative data by ranking - assigning values 0-2 to the categories of food consumption frequency. Then diet quality indicators will be calculated - pro-Healthy-Diet-Index-10 (pHDI - range 0-20), non-Healthy-Diet-Index-14 (nHDI - range 0 - 28), Diet-Quality-Index (DQI - range -100-100). The higher the value of the pHDI or DQI index, the greater the intensity of nutritional features beneficial to health and the better the quality of the diet. The higher the value of the nHDI index, the greater the intensity of nutritional characteristics unfavorable for health and the worse the quality of the diet. In addition, this method will be supplemented with the current dietary recording for the last 4 days.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in bone density
Bone density 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.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in the concentration of short-chain fatty acids in feces
Quantitative and qualitative determination of short-chain fatty acids in feces will be carried out using the gas chromatography method with flame ionization detection (GC-FID). The research will be carried out at the Department and Department of Bromatology, Medical University of Poznań.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in intestinal barrier integrity
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. Lipopolysaccharide concentrations will be assessed using the ELISA enzyme-linked immunosorbent assay.
Measured: Week 0 (pre-intervention) and week 4 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start16 Nov 2024
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Postmenopausal women (n=40), aged 45-65.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanna Bajerska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joanna Bajerska, Poznan University of Life Sciences
- Investigators
- Agata Chmurzyńska, Prof., Study chair, Department of Human Nutrition and Dietetics, Poznań University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673199
- Sponsor's protocol ID
- 661/24-Washoku diet
- Status last verified
- Sep 2026
- First submitted
- 29 Oct 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Numerical data, statistics and graphs data will be deposited in the Open Data Repository RepOD - the PULS institutional repository, and made publicly available in the Repository at the latest at the time when the publication presenting research data is published including a maximum 36-month embargo period due to the requirements and specifics of the publication of the article presenting the research results. Upon publication, the embargo will be lifted immediately. Unless there is a clear indication to the contrary, the data will be made available in the RepOD repository under a CC BY 4.0 license. Raw and processed data will be stored for at least 10 years. Personal data will be deleted after the pseudonymization process.
Publications
Yang M, Wen S, Zhang J, Peng J, Shen X, Xu L. Systematic Review and Meta-analysis: Changes of Gut Microbiota before and after Menopause. Dis Markers. 2022 Jul 25;2022:3767373. doi: 10.1155/2022/3767373. eCollection 2022.
PubMed 35923245Kanai T, Matsuoka K, Naganuma M, Hayashi A, Hisamatsu T. Diet, microbiota, and inflammatory bowel disease: lessons from Japanese foods. Korean J Intern Med. 2014 Jul;29(4):409-15. doi: 10.3904/kjim.2014.29.4.409. Epub 2014 Jun 27.
PubMed 25045286Seura T, Fukuwatari T. Japanese Diet Score Is Associated with Gut Microbiota Composition in Young Japanese Adults. J Nutr Sci Vitaminol (Tokyo). 2019;65(5):414-420. doi: 10.3177/jnsv.65.414.
PubMed 31666478Gabriel AS, Ninomiya K, Uneyama H. The Role of the Japanese Traditional Diet in Healthy and Sustainable Dietary Patterns around the World. Nutrients. 2018 Feb 3;10(2):173. doi: 10.3390/nu10020173.
PubMed 29401650Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
PubMed 25841598
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Japanese "Washoku" Diet on the Composition of the Gut Microbiota and Its Metabolites in Overweight or Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06673199
- Acronym / sponsor ID
- 661/24-Washoku diet
- Conditions
- Menopause
- Keywords
- menopause, microbiota, isoflavones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Joanna BajerskaUniversity, hospital or other
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women who meet the criteria for inclusion in the study for a period of 4 weeks will be randomly assigned to one of two groups: 1. The intervention group will follow the principles of the healthy eating plate, which will be supplemented with elements of the washoku diet (30 g of roasted black soybeans and 5 g of wakame); 2. The control group will be covered only by the principles of the healthy eating plate.
All participants will receive a brochure with information on the recommended portion sizes of individual product groups in the daily diet, recipes for dishes based on roasted black soybeans and wakame. Before and after the study, in addition to anthropometric measurements (body weight, waist circumference, hip circumference), body composition and bone mineral density, an assessment of the diet (using a semi-quantitative questionnaire of food frequency, as well as the current recording method from the last 4 days) and the level of physical activity will be carried out. Additionally, the women will be asked to collect a daily portion of urine to assess the concentration of soy isoflavones and to determine the content of sodium, potassium and magnesium. Women will also have their blood (18 ml) collected to assess selected biochemical parameters (glucose, insulin, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-HDL cholesterol (non-HDL-C) and triglycerides). A stool sample will also be collected to assess the composition of the intestinal microbiota and its metabolites, i.e. short-chain fatty acids. Recruitment will take place via social networking sites, i.e. Facebook.
The following specific analyses were planned:
- Assessment of anthropometric parameters (height, body weight, hips and waist circumference)
- Analysis of body composition and bone mineral density
- Assessment of nutritional status (selected metabolic parameters such as glucose metabolism (glucose, insulin concentration), lipid metabolism (total cholesterol (T-C), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), non-HDL cholesterol (non-HDL-C) and triglycerides).
- Assessment of dietary habits (a semi-quantitative questionnaire on the frequency of food intake, additionally supplemented by the current recording method from the last 4 days.)
- Assessment of intestinal microbiota composition
- Assessment of fecal short-chain fatty acid concentration
- Assessment of urine soy isoflavones concentration
Normality of the obtained data distribution will be tested using the Shapiro-Wilk test. The Kruskal-Wallis test then will be used for nonnormally distributed data and the Tukey HSD test will be used for normally distributed data. A p value of less than 0.05 was considered statistically. The microbiota composition will be analyzed using RStudio (R version 4.0.3 (2020-10-10)) with packages including phyloseq, microbiome, and vegan. Taxa will be filtered by removing all those not assigned to any phylum. Only taxa with abundances over 0.25% in at least one sample will left in the dataset. All analyses of gut microbiota composition will be performed on the basis of the relative abundances (RA) of the OTUs (Operational Taxonomic Units).
The data collected in the planned studies will include the results of measurements and their statistical analyzes. All data will be collected directly by team members and coded. Detailed instructions on data collection will be prepared by the team leader and each member will need to read and receive appropriate training. All biochemical and anthropometric measurements will be performed in at least two repetitions and will be checked by another team member. All used specialized equipment will be properly calibrated before each use (scale, body composition analyzer, Nanodrop spectrophotometer).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Postmenopausal women (n=40), aged 45-65.
| Arm | Type | Receives |
|---|---|---|
| Washoku diet | Experimental | Dietary Supplement: Washoku dietParticipants assigned to the washoku group will be introduced to the principles of a healthy eating plate, which will be supplemented with elements of the washoku diet (30 g of roasted black soybeans and 5 g of wakame). |
| Control group | No intervention | –Participants assigned to the control group will receive only dietary recommendations consistent with the healthy eating plate. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 45 to 65,
- at least one year after natural menopause,
- BMI > 25 kg/m2
- waist circumference > 80 cm.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Washoku dietThe 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 on the day of the first meeting. The Washoku diet will be used for 7 days a week for a period of 1 month (4 weeks). | Dietary supplement | Washoku diet |
Primary outcome
Change in composition of the intestinal microbiota
Time frame: 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 secured and sent to an external company, Genomed S.A. (Warsaw, Poland), in which the assessment of microbiota will be carried out by metagenomic 16s rRNA sequencing using the V3-V4 region. Then, a bioinformatics analysis will be performed in the R environment using packages such as phyloseq, vegan, microbiome.
Change in body weight
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 be determined by a certified external laboratory. The nonHDL-C parameter will be calculated using the formula: nonHDL-C = T-C - HDL-C. (expressed in the same unit - mg/dl or mmol/l).
Change in glucose metabolism
Time frame: 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. Insulin concentration will be performed using the ELISA enzyme-linked immunosorbent assay, while glucose will be determined by a certified external laboratory. (expressed in the same unit - mg/dl or mmol/l).
Change in urinary isoflavone content
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Soy isoflavone concentrations will be assessed in a 24-hour urine sample provided by women before and after the study using high-performance liquid chromatography.
Change in urine pH
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
pH will be assessed in a 24-hour urine sample provided by women before and after the study using litmus paper or laboratory pH meter.
Change in urine creatinine
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Creatinine concentration will be assessed in a 24-hour urine sample provided by women before and after the study using high-performance liquid chromatography.
Change in urine sodium and magnesium
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Sodium and magnesium concentrations will be assessed in a 24-hour urine sample provided by women before and after the study using automatic electrolyte analyzer.
4 secondary outcomes
Changes in results of nutrition assessment
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in bone density
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in the concentration of short-chain fatty acids in feces
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Change in intestinal barrier integrity
Time frame: Week 0 (pre-intervention) and week 4 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 35923245Yang M, Wen S, Zhang J, Peng J, Shen X, Xu L. Systematic Review and Meta-analysis: Changes of Gut Microbiota before and after Menopause. Dis Markers. 2022 Jul 25;2022:3767373. doi: 10.1155/2022/3767373. eCollection 2022.
- Background: PubMed 25045286Kanai T, Matsuoka K, Naganuma M, Hayashi A, Hisamatsu T. Diet, microbiota, and inflammatory bowel disease: lessons from Japanese foods. Korean J Intern Med. 2014 Jul;29(4):409-15. doi: 10.3904/kjim.2014.29.4.409. Epub 2014 Jun 27.
- Background: PubMed 31666478Seura T, Fukuwatari T. Japanese Diet Score Is Associated with Gut Microbiota Composition in Young Japanese Adults. J Nutr Sci Vitaminol (Tokyo). 2019;65(5):414-420. doi: 10.3177/jnsv.65.414.
- Background: PubMed 29401650Gabriel AS, Ninomiya K, Uneyama H. The Role of the Japanese Traditional Diet in Healthy and Sustainable Dietary Patterns around the World. Nutrients. 2018 Feb 3;10(2):173. doi: 10.3390/nu10020173.
- Background: PubMed 25841598Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
- Individual participant dataSharing planned: Yes. Numerical data, statistics and graphs data will be deposited in the Open Data Repository RepOD - the PULS institutional repository, and made publicly available in the Repository at the latest at the time when the publication presenting research data is published including a maximum 36-month embargo period due to the requirements and specifics of the publication of the article presenting the research results. Upon publication, the embargo will be lifted immediately. Unless there is a clear indication to the contrary, the data will be made available in the RepOD repository under a CC BY 4.0 license. Raw and processed data will be stored for at least 10 years. Personal data will be deleted after the pseudonymization process.
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agata Chmurzyńska, Prof. study chair
Department of Human Nutrition and Dietetics, Poznań University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Washoku diet in people with Menopause, run by Joanna Bajerska at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composition of the intestinal microbiota (time frame: Week 0 (pre-intervention) and week 4 (post-intervention)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06673199, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.