ObesityNCT03100162
Effect of Oral Supplementation With Probiotics
A study testing Probiotic in people with Obesity, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora and intestinal epithelial permeability, mineral content and lifestyle in obese women with postmenopausal metabolic syndrome: double-blind, randomized clinical trial. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 sitePoland
- Study dates
- 27 Feb 2016to 2 Feb 2018
- Phase
- Interventional
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) equal to or greater than 30 kg/m2
- age 45 to 70 years
- stable body weight (< 3 kg self-reported change during the previous three months)
- written informed consent to participate in the study,
- > = 1 year after the last menstrual period;
- abdominal obesity - waist circumference> 80 cm;
- body fat content measured by bio-impedance ≥ 33%;
Who cannot join
- secondary obesity or secondary hypertension
- diabetes type I
- gastrointestinal disease;
- dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up;
- a history of use of any dietary supplements within the one month prior to the study
- taking antibiotics within 1 month before starting the study;
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- Clinically relevant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
- simultaneous participation in a study that affects weight change or use of diet / medication / nutritional behaviors affecting body weight changes;
- consumption of pre- and probiotic-enriched products (for at least 3 weeks prior to the first screening visit) and products with high fiber content or large amounts of fermented foods (> 400g / day);
- hormone replacement therapy;
- a history of infection in the month prior to the study
- nicotine, drug or alcohol abuse
- vegetarian diet;
- or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences
Poznan, 60-569
About this study
Official title: Effect of Oral Supplementation With Probiotics on Cardiometabolic Risk Factors, Microflora and Intestinal Epithelial Permeability, Mineral Content and Lifestyle in Obese Women With Postmenopausal Metabolic Syndrome: Double-blind, Randomized Clinical Trial.
Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora and intestinal epithelial permeability, mineral content and lifestyle in obese women with postmenopausal metabolic syndrome: double-blind, randomized clinical trial.
Read the detailed description
The purpose of the study is to determine whether oral probiotic supplementation affects cardiometabolic risk, intestinal epithelial permeability, metabolic activity and intestinal flora composition, mineral content, and lifestyle in obese women with metabolic syndrome.
Probiotics are a group of non-pathogenic microbes that bring health benefits to the host. Their use enables the variety and proper functioning of intestinal microflora. The use of probiotics increases the amount of bifidobacteria and lactobacilli, what directly affects the reduction of endotoxemia by sealing the intestinal wall, as well as the improvement of fat, carbohydrate and insulin metabolism.
The project is due to evaluate the effect of supplementation with selected probiotics in patients with metabolic syndrome on:
- lipid metabolism- total cholesterol, HDL and LDL cholesterol and triglycerides,
- blood glucose concentration,
- blood pressure values,
- anthropometric parameters,
- quality of life,
- the contentl of minerals,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Individuals receive a placebo daily, for 3 months. Receives: Dietary Supplement: Placebo |
| Probiotic 2g | Active comparator | Individuals receive 2 g of probiotic daily, for 3 months. Receives: Dietary Supplement: Probiotic |
| Probiotic 4g | Active comparator | Individuals receive 4 g of probiotic daily, for 3 months. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with decreased cardiometabolic risk
Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking). The number of patients with decreased cardiometabolic risk will be measured.
Measured: At the baseline and after 3 months of treatment
Secondary outcomes (11)
blood pressure
Measured: At the baseline and following 3 months of treatment
Body mass index
Measured: At the baseline and following 3 months of treatment
waist circumference
Measured: At the baseline and following 3 months of treatment
serum lipids
Measured: At the baseline and following 3 months of treatment
Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
Measured: At the baseline and following 3 months of treatment
insulin estimated by immunoassay (DIAsource immunoassays)
Measured: At the baseline and following 3 months of treatment
interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)
Measured: At the baseline and following 3 months of treatment
Total body fat content
Total body fat content will be measured at baseline and after 3 months of treatment using electrical bioimpedance
Measured: At the baseline and following 3 months of treatment
Measurement of mineral content in hair
The content of iron, magnezium, calcium, selenium, copper and lead in patients' hair at baseline and after 3 months of treatment will be estimated using atomic absorption spectrometry.
Measured: At the baseline and following 3 months of treatment
Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna )
Measured: At the baseline and following 3 months of treatment
Quality of life
"The World Health Organization Quality of Life (WHOQOL) - BREF"
Measured: At the baseline and following 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start27 Feb 2016
- Primary completion4 Jan 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Poznan University of Life Sciences
- Responsible party
- Principal investigator, Pawel Bogdanski, Poznan University of Medical Sciences
- Investigators
- Pawel Bogdanski, MD PhD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100162
- Sponsor's protocol ID
- 871/15
- Status last verified
- May 2020
- First submitted
- 22 Mar 2017
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Supplementation With Probiotics on Cardiometabolic Risk Factors, Microflora and Intestinal Epithelial Permeability, Mineral Content and Lifestyle in Obese Women With Postmenopausal Metabolic Syndrome: Double-blind, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03100162
- Acronym / sponsor ID
- 871/15
- Conditions
- Obesity
- Keywords
- probiotics, metabolic syndrome, obesity, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Poznan University of Life Sciences
- Study start
- 27 Feb 2016 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 4 Apr 2017 (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.
Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora and intestinal epithelial permeability, mineral content and lifestyle in obese women with postmenopausal metabolic syndrome: double-blind, randomized clinical trial.
Detailed description
The purpose of the study is to determine whether oral probiotic supplementation affects cardiometabolic risk, intestinal epithelial permeability, metabolic activity and intestinal flora composition, mineral content, and lifestyle in obese women with metabolic syndrome.
Probiotics are a group of non-pathogenic microbes that bring health benefits to the host. Their use enables the variety and proper functioning of intestinal microflora. The use of probiotics increases the amount of bifidobacteria and lactobacilli, what directly affects the reduction of endotoxemia by sealing the intestinal wall, as well as the improvement of fat, carbohydrate and insulin metabolism.
The project is due to evaluate the effect of supplementation with selected probiotics in patients with metabolic syndrome on:
- lipid metabolism- total cholesterol, HDL and LDL cholesterol and triglycerides,
- blood glucose concentration,
- blood pressure values,
- anthropometric parameters,
- quality of life,
- the contentl of minerals,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIndividuals receive a placebo daily, for 3 months. |
| Probiotic 2g | Active comparator | Dietary Supplement: ProbioticIndividuals receive 2 g of probiotic daily, for 3 months. |
| Probiotic 4g | Active comparator | Dietary Supplement: ProbioticIndividuals receive 4 g of probiotic daily, for 3 months. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- body mass index (BMI) equal to or greater than 30 kg/m2
- age 45 to 70 years
- stable body weight (< 3 kg self-reported change during the previous three months)
- written informed consent to participate in the study,
- > = 1 year after the last menstrual period;
Key exclusion criteria (14 listed)
- secondary obesity or secondary hypertension
- diabetes type I
- gastrointestinal disease;
- dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up;
- a history of use of any dietary supplements within the one month prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic | Dietary supplement | Probiotic 2g, Probiotic 4g |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Number of patients with decreased cardiometabolic risk
Time frame: At the baseline and after 3 months of treatment
Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking). The number of patients with decreased cardiometabolic risk will be measured.
11 secondary outcomes
blood pressure
Time frame: At the baseline and following 3 months of treatment
Body mass index
Time frame: At the baseline and following 3 months of treatment
waist circumference
Time frame: At the baseline and following 3 months of treatment
serum lipids
Time frame: At the baseline and following 3 months of treatment
Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
Time frame: At the baseline and following 3 months of treatment
insulin estimated by immunoassay (DIAsource immunoassays)
Time frame: At the baseline and following 3 months of treatment
interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)
Time frame: At the baseline and following 3 months of treatment
Total body fat content
Time frame: At the baseline and following 3 months of treatment
Measurement of mineral content in hair
Time frame: At the baseline and following 3 months of treatment
Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna )
Time frame: At the baseline and following 3 months of treatment
Quality of life
Time frame: At the baseline and following 3 months of treatment
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 6 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Pawel Bogdanski, MD PhD principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Obesity, run by Poznan University of Medical Sciences at 1 site in Poland.
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 7 inclusion and 14 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. Some participants in this study may receive a placebo. 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?
Number of patients with decreased cardiometabolic risk (time frame: At the baseline and after 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020.