Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
FEMALE
NCT06673199

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

Led by Joanna Bajerska · Updated on 2024-11-14

40

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 45 and 65 years
  • At least one year after natural menopause
  • Body mass index (BMI) over 25 kg/m2
  • Waist circumference greater than 80 cm
Not Eligible

You will not qualify if you...

  • Use of hormone replacement therapy
  • Use of antibiotics or probiotics within the last 6 months
  • Use of medications affecting carbohydrate or lipid metabolism within the last 4 weeks
  • Use of medications regulating body weight within the last 3 months
  • Having diseases of the thyroid gland, liver, heart, kidneys, digestive system, anemia, or cancer
  • Smoking or consuming alcohol exceeding 100 grams per week

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Poznań University of Life Sciences

Poznan, Wielkopolska, Poland

Actively Recruiting

Loading map...

Research Team

J

Joanna Bajerska, Assoc. Prof.

CONTACT

J

Joanna M. Pieczyńska-Zając, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here