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Clinical Trials/NCT05364814
NCT05364814CompletedNot Applicable

The Effect of Using Probiotic Yogurt on Anthropometric Measurements and Gastrointestinal System in Obese Women

Yuksek Ihtisas University1 site in 1 country21 target enrollmentStarted: February 2, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
21
Locations
1
Primary Endpoint
Determining Change in Obesity

Study Overview

Brief Summary

This study aimed to examine the effects of using probiotic yogurt on body components (body weight, height, etc.) and digestive system (distention, gas, etc.) in obesity (obese women), which is an important public health problem all over the world.

Detailed Description

Obesity is an important public health problem worldwide and is associated with non-communicable diseases such as Type 2 Diabetes, hypertension, coronary heart disease, hyperlipidemia, non-alcoholic fatty liver, some neoplasms, and infertility disease.However, it is supported by the literature that nutrition and obesity cause microbial dysbiosis.

In this study, it was aimed to use probiotics and yogurt with the thought that nutrition can manipulate the microbiota.

It was aimed to investigate the effects of probiotic yogurt consumption on anthropometric measurements, metabolic parameters, and gastrointestinal symptoms in obese women (25-45 years old) with the prospective method.

The study was carried out in patients who were diagnosed with obesity by the doctor, consulted the Dietitian, and accepted + signed the voluntary consent form.

Total data and measurements were followed and recorded by the same Dietitian. Compliance with medical nutrition therapy, recording of scales were followed weekly.Patients diagnosed with COVID-19 during the study were excluded from the study.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Female patients aged 25-45 years, with a BMI of 27-35 kg/m2 diagnosed as obese by the doctor
  • •Female patients without a chronic disease
  • •Female patients between the ages of 25-45 with regular menstrual cycles,
  • •Female patients between the ages of 25-45 who are not pregnant or lactating
  • •Female patients who do not use drugs, herbal products, etc. nutritional supplements.

Exclusion Criteria

  • •Patients with BMI≥ 36 kg/m2
  • •Patients with diabetes, gastrointestinal diseases, CRF, etc.
  • •Women in pregnancy and lactation period,
  • •Male patients
  • •Weight loss medicine etc. patients with drug use
  • •Patients who use antibiotics
  • •Patients using probiotics, propolis, herbal products, etc.
  • •Patients with menstrual irregularity
  • •Female patients who have entered the menopause

Outcomes

Primary Outcomes

Determining Change in Obesity

Time Frame: 1 time per week/5 weeks

* Mean percent change in initial and final body weight (kilogram) * Mean percent change initial and final waist circumference (cm): * Mean percent change initial and final waist/height ratio: It will be calculated by dividing waist circumference by height. The cut-off point of ratio will be taken as 0.5. * Mean percent change initial and final waist/hip ratio:The cut-off point for the Waist/Hip ratio, which was determined by dividing the waist circumference by the hip circumference, was determined as ≥0.90 cm for men and ≥0.85 cm for women. * Mean percent change initial and final fat mass: It measurement of individuals will be measured with the Body Composition Analyzer (in % and kg units). It is based on the difference in electrical permeability of fat-free tissue mass and fat. * Biochemical parameters was determined in mg/dL following the protocols established for: high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides and fasting glucose.

Secondary Outcomes

  • Changes on the Gastrointestinal System(1 time per week/5 weeks)

Investigators

Sponsor
Yuksek Ihtisas University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sevan ÇETİN ÖZBEK

Assistant Proffesor

Yuksek Ihtisas University

Study Sites (1)

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