Use of Probiotic Yogurt in Obese Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364814
• Other study ID #: YuksekIU02
• Status: Completed
• Start date: February 2, 2022
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2022
• Source: Yuksek Ihtisas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 15, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Obesity

Locations

Country	Name	City	State
Turkey	Malatya Training and Research Hospital	Malatya
Turkey	Malatya Training and Research Hospital	Malatya

Sponsors (3)

Lead Sponsor	Collaborator
Yuksek Ihtisas University	Malatya Egitim Ve Arastirma Hastanesi, Turgut Ozal University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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). pii: E3011. doi: 10.3390/nu11123011. — View Citation

Mazloom K, Siddiqi I, Covasa M. Probiotics: How Effective Are They in the Fight against Obesity? Nutrients. 2019 Jan 24;11(2). pii: E258. doi: 10.3390/nu11020258. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining Change in Obesity	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.	1 time per week/5 weeks
Secondary	Changes on the Gastrointestinal System	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.	1 time per week/5 weeks