ObesityNCT05364814
Use of Probiotic Yogurt in Obese Women
An observational study of Obesity and Dysbioses, run by Yuksek Ihtisas University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- How many people
- 21 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 15 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patients using probiotics, propolis, herbal products, etc.
- Patients with menstrual irregularity
- Female patients who have entered the menopause
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Malatya Training and Research Hospital
Malatya, 44330
Malatya Training and Research Hospital
Malatya
About this study
Official title: The Effect of Using Probiotic Yogurt on Anthropometric Measurements and Gastrointestinal System 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.
Read the 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.
- Medical subject headings
- Obesity, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 time per week/5 weeks
Secondary outcomes (1)
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.
Measured: 1 time per week/5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start2 Feb 2022
- Primary completion1 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Collaborators
- Malatya Egitim Ve Arastirma Hastanesi, Turgut Ozal University
- Responsible party
- Principal investigator, Sevan ÇETİN ÖZBEK, Yuksek Ihtisas University
- Investigators
- Sevan ÇETİN ÖZBEK, Study director, Yüksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364814
- Sponsor's protocol ID
- YuksekIU02
- Status last verified
- Jul 2022
- First submitted
- 3 May 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31835452Wang 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.
PubMed 31118956Mazloom 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.
PubMed 30678355
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Probiotic Yogurt on Anthropometric Measurements and Gastrointestinal System in Obese Women
- ClinicalTrials.gov ID
- NCT05364814
- Acronym / sponsor ID
- YuksekIU02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Collaborators
- Malatya Egitim Ve Arastirma Hastanesi, Turgut Ozal University
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Changes on the Gastrointestinal System
Time frame: 1 time per week/5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 31835452Cancello 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.
- Background: PubMed 31118956Wang 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.
- Background: PubMed 30678355Mazloom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevan ÇETİN ÖZBEK study director
Yüksek Ihtisas University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Dysbioses, run by Yuksek Ihtisas University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining Change in Obesity (time frame: 1 time per week/5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364814, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.