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

NCT06673199 | Recruiting

• 1 other identifier: 661/24-Washoku diet
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

menopause; microbiota; isoflavones

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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)

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  Week 0 (pre-intervention) and week 4 (post-intervention)

Secondary Outcomes (4)

• Changes in results of nutrition assessment

  Week 0 (pre-intervention) and week 4 (post-intervention)

• Change in bone density

  Week 0 (pre-intervention) and week 4 (post-intervention)

• Change in the concentration of short-chain fatty acids in feces

  Week 0 (pre-intervention) and week 4 (post-intervention)

• Change in intestinal barrier integrity

  Week 0 (pre-intervention) and week 4 (post-intervention)

Study Arms (2)

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).

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.

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 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).

Washoku diet

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Joanna Bajerska: lead

Study Sites (1)

Poznań University of Life Sciences

Poznan, Wielkopolska, Poland

RECRUITING

Related Publications (5)

• 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.

  PMID: 35923245 BACKGROUND

• Kanai 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.

  PMID: 25045286 BACKGROUND

• Seura 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.

  PMID: 31666478 BACKGROUND

• Gabriel 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.

  PMID: 29401650 BACKGROUND

• Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.

  PMID: 25841598 BACKGROUND

Study Officials

• Agata Chmurzyńska, Prof.

  Department of Human Nutrition and Dietetics, Poznań University of Life Sciences

  STUDY CHAIR

Central Study Contacts

Joanna Bajerska, Assoc. Prof.

CONTACT

8466056; Joanna.bajerska@up.poznan.pl

Joanna M. Pieczyńska-Zając, M.Sc.

CONTACT

660 950 786; joanna.pieczynska@up.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Postmenopausal women (n=40), aged 45-65.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 4, 2024
• Study Start: November 16, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 12, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD data will be made available after publication of all planned articles presenting the results of the planned experiment for a period of 10 years.
• Access Criteria: All persons having access to data have to be authorised to process personal data. A secured work e-mail is used for correspondence. Access to collected and processed sensitive data will be limited solely to the group of authorised users. The Head of the project authorises individuals to have access to data. The e-mail requesting access to the IPD should include your name and surname, academic degree and affiliation. Data will only be made available after the person's identity has been verified and the purpose of using the data is clear (e.g. meta-analysis). Then, the data owner will verify the need to have the data and send it in a password-protected form. All data will be pseudonymized.

Locations

PL (1)