NCT05364814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

May 3, 2022

Last Update Submit

July 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes on the Gastrointestinal System

    1 time per week/5 weeks

Study Arms (1)

Obese Group

A single sample group . Anthropometric measurements were taken at the beginning of all patients. Yogurt with probiotic added to medical nutrition therapy was applied for 2 weeks.Anthropometric measurements were taken at the beginning of all patients. Yogurt with probiotic added to medical nutrition therapy was applied for 2 weeks. At the end of each week, food consumption records and scales were applied. During the wash out period, all patients were asked to comply with their diet only. After the wash out period, a different diet was started and the same procedures were repeated.During the wash out period, all patients were asked to comply with their diet only. After the wash out period, a different diet (with the addition of probiotic yogurt) was changed and the same procedures were repeated.

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe female gender was preferred in terms of ensuring homogeneity and sustainability of the diet.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Malatya Training and Research Hospital

Malatya, 44330, Turkey (Türkiye)

Location

Malatya Training and Research Hospital

Malatya, Turkey (Türkiye)

Location

Related 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):3011. doi: 10.3390/nu11123011.

    PMID: 31835452BACKGROUND
  • 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.

    PMID: 31118956BACKGROUND
  • 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.

    PMID: 30678355BACKGROUND

MeSH Terms

Conditions

ObesityDysbiosis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Sevan ÇETİN ÖZBEK

    Yüksek Ihtisas University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 6, 2022

Study Start

February 2, 2022

Primary Completion

April 1, 2022

Study Completion

April 15, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations