Use of Probiotic Yogurt in Obese Women

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.

Completed

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Key information

Conditions

Obesity Body Weight Dysbioses Dysbiosis Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Malatya Training and Research Hospital, Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 1 time per week/5 weeks
- Evaluation of the difference between individuals according to the Bristol Stool Scale. The Bristol Stool Scale is used to determine stool. The scale has seven stool types for visual identification of stool.
- Gastrointestinal Symptom Rating Scale:The scale, which consists of 15 questions, includes questions about abdominal pain, heartburn, reflux nausea, dyspepsia and stool consistency.

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas University

Other

Collaborators

Malatya Egitim Ve Arastirma Hastanesi
Turgut Ozal University

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: May 6, 2022
Registry last updated: Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed