Clinical trial NCT05364814: Use of Probiotic Yogurt in Obese Women
Official title: The Effect of Using Probiotic Yogurt on Anthropometric Measurements and Gastrointestinal System in Obese Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Dysbioses
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
Collaborators: name: Malatya Egitim Ve Arastirma Hastanesi
name: Turgut Ozal University
First posted: 2022-05-06
Enrollment: 21
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: She was diagnosed with obesity by a doctor at Malatya Turgut Özal University Training and Research Hospital and was consulted to the Diet Polyclinic for appropriate Medical Nutrition Therapy; patients aged 25-45, female, with a BMI of 27 -35 kg/m2, who read and signed the voluntary consent form.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determining Change in Obesity
timeFrame: 1 time per week/5 weeks
Secondary outcomes:
measure: Changes on the Gastrointestinal System
timeFrame: 1 time per week/5 weeks
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Malatya Training and Research Hospital
city: Malatya
country: Turkey
facility: Malatya Training and Research Hospital
Study officials:
affiliation: Yüksek Ihtisas University
name: Sevan ÇETİN ÖZBEK
role: STUDY_DIRECTOR
References:
citation: Cancello R, Turroni S, Rampelli S, Cattaldo S, Candela M, Cattani L, Mai S, Vietti R, Scacchi M, Brigidi P, Invitti C. Effect of Short-Term Dietary Intervention and Probiotic Mix Supplementation on the Gut Microbiota of Elderly Obese Women. Nutrients. 2019 Dec 10;11(12):3011. doi: 10.3390/nu11123011.
citation: Wang ZB, Xin SS, Ding LN, Ding WY, Hou YL, Liu CQ, Zhang XD. The Potential Role of Probiotics in Controlling Overweight/Obesity and Associated Metabolic Parameters in Adults: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Apr 15;2019:3862971. doi: 10.1155/2019/3862971. eCollection 2019.
citation: Mazloom K, Siddiqi I, Covasa M. Probiotics: How Effective Are They in the Fight against Obesity? Nutrients. 2019 Jan 24;11(2):258. doi: 10.3390/nu11020258.