Metabolic SyndromeNCT03966846
Kefir and Metabolic Syndrome
A study testing Kefir and Milk in people with Metabolic Syndrome and Obesity, run by Izmir Katip Celebi University.
Trial summary
Metabolic syndrome is a cluster of metabolic disorders which increases the risk for diabetes and cardiovascular disease. In recent years, research has shown that probiotics may have positive effects on metabolic syndrome components. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Obesity, Hypertension
- What is being tested?
- Kefir and Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old subjects
- Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria.
Who cannot join
- Existence of lactose intolerance
- Existence of type 1 diabetes
- Existence of abnormal thyroid hormone levels
- Existence of chronic gastrointestinal system disease
- Existence of cancer
- Existence of severe liver disease
Show all 14Show fewer
- Existence of kidney insufficiency
- Existence of immunodeficiency
- Taking medication to regulate blood glucose (except metformin) or lipid levels
- Taking antibiotics prior to one month of the study
- Consuming regular probiotic food or supplement
- Taking supplement which may affect the metabolic outcomes such as prebiotic or omega-3
- Dieting for weight loss or for another disease
- Being pregnant and breastfeeding.
About this study
Official title: The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study
Metabolic syndrome is a cluster of metabolic disorders which increases the risk for diabetes and cardiovascular disease. In recent years, research has shown that probiotics may have positive effects on metabolic syndrome components. Although several health-promoting effects of kefir, have been suggested, there is limited evidence for its potential effect on metabolic syndrome. Therefore, it is necessary to clarify the effects of kefir on metabolic disorders including obesity, dyslipidemia, diabetes, and hypertension. To address the research gap, this study aimed to investigate the effects of daily kefir consumption on metabolic syndrome components, inflammatory response and gut microbiota composition in adults with MetS. The study was planned as a randomized, controlled, parallel design and completed with a total of 62 individuals who were diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria. Participants were randomized into two groups and received daily 180 ml of kefir (n=31) or milk (as control) (n=31) for 12 weeks. Participants were assessed at baseline, week 4, week 8, and week 12 and at all controls dietary records, anthropometric measurements, and blood samples were collected. At baseline and 12th-week fecal samples were also collected in order to analyze gut microbiota composition.
- Conditions
- Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Insulin Resistance
- Being tested
- Kefir, Milk
- Keywords
- probiotics, dairy products, kefir, gut microbiota
- Medical subject headings
- Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KefirDietary supplement
MilkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Kefir Group | Experimental | Kefir group received one bottle of kefir (180 ml) daily for 12 weeks. Microbial composition of the kefir included Lactococcus lactis ssp. lactis, Lactococcus lactis ssp. cremoris, Lactococcus lactis ssp. diacetylactis, Leuconostoc mesenteroides ssp. cremoris, Lactobacillus kefyr, Kliyveromyces marxianus, and Saccharomyces unisporus. Receives: Dietary Supplement: Kefir |
| Control Group | Placebo comparator | Control group received one bottle of milk (180 ml) daily for 12 weeks. Receives: Dietary Supplement: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipid profile
Measurement of lipid profile (HDL cholesterol, triglyceride levels)
Measured: baseline, week 4, week 8 and week 12
Changes in glycemic profile
Measurement of fasting glucose, insulin, and calculation of HOMA-IR
Measured: baseline, week 4, week 8 and week 12
Changes in gut microbiota
Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)
Measured: week 0- week 12
Secondary outcomes (10)
Changes in Inflammatory Parametres
Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-α, IL-6, IL-10 ve IFN-γ)
Measured: baseline and week 12
Changes in serum cholesterol levels
Measurement of total cholesterol and its fractions (mg/dl)
Measured: baseline, week 4, week 8 and week 12
Changes in triglycerides
Measurement of serum triglyceride (mg/dl)
Measured: baseline, week 4, week 8 and week 12
Changes in lipoproteins
Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))
Measured: baseline and week 12
Changes in homocysteine
Measurement of homocysteine (umol/L)
Measured: baseline and week 12
Changes in glycated hemoglobin
Measurement of HbA1c (%)
Measured: baseline and week 12
Changes in blood pressure
Measurement of systolic and diastolic blood pressure (mm Hg)
Measured: baseline, week 4, week 8 and week 12
Changes in waist circumference
Measurement of waist circumference (cm)
Measured: baseline, week 4, week 8 and week 12
Changes in Body Fat
Measurement of % body fat with BIA
Measured: baseline, week 4, week 8 and week 12
Changes in BMI
weight and height will be measured to report BMI in kg/m2
Measured: baseline, week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study startMar 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Model description
- There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Turkey Council of Higher Education Teaching Stuff Training Program, Ege University
- Responsible party
- Principal investigator, Ezgi Bellikci Koyu, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966846
- Sponsor's protocol ID
- 152114
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Bellikci-Koyu E, Sarer-Yurekli BP, Karagozlu C, Aydin-Kose F, Ozgen AG, Buyuktuncer Z. Probiotic kefir consumption improves serum apolipoprotein A1 levels in metabolic syndrome patients: a randomized controlled clinical trial. Nutr Res. 2022 Jun;102:59-70. doi: 10.1016/j.nutres.2022.02.006. Epub 2022 Mar 7.
PubMed 35405603
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03966846
- Acronym / sponsor ID
- 152114
- Conditions
- Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Insulin Resistance
- Keywords
- probiotics, dairy products, kefir, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University, Turkey Council of Higher Education Teaching Stuff Training Program, Ege University
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 May 2019 (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.
Metabolic syndrome is a cluster of metabolic disorders which increases the risk for diabetes and cardiovascular disease. In recent years, research has shown that probiotics may have positive effects on metabolic syndrome components. Although several health-promoting effects of kefir, have been suggested, there is limited evidence for its potential effect on metabolic syndrome. Therefore, it is necessary to clarify the effects of kefir on metabolic disorders including obesity, dyslipidemia, diabetes, and hypertension. To address the research gap, this study aimed to investigate the effects of daily kefir consumption on metabolic syndrome components, inflammatory response and gut microbiota composition in adults with MetS. The study was planned as a randomized, controlled, parallel design and completed with a total of 62 individuals who were diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria. Participants were randomized into two groups and received daily 180 ml of kefir (n=31) or milk (as control) (n=31) for 12 weeks. Participants were assessed at baseline, week 4, week 8, and week 12 and at all controls dietary records, anthropometric measurements, and blood samples were collected. At baseline and 12th-week fecal samples were also collected in order to analyze gut microbiota composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
| Arm | Type | Receives |
|---|---|---|
| Kefir Group | Experimental | Dietary Supplement: KefirKefir group received one bottle of kefir (180 ml) daily for 12 weeks. Microbial composition of the kefir included Lactococcus lactis ssp. lactis, Lactococcus lactis ssp. cremoris, Lactococcus lactis ssp. diacetylactis, Leuconostoc mesenteroides ssp. cremoris, Lactobacillus kefyr, Kliyveromyces marxianus, and Saccharomyces unisporus. |
| Control Group | Placebo comparator | Dietary Supplement: MilkControl group received one bottle of milk (180 ml) daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old subjects
- Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria.
Key exclusion criteria (14 listed)
- Existence of lactose intolerance
- Existence of type 1 diabetes
- Existence of abnormal thyroid hormone levels
- Existence of chronic gastrointestinal system disease
- Existence of cancer
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 |
|---|---|---|
| Kefir | Dietary supplement | Kefir Group |
| Milk | Dietary supplement | Control Group |
Primary outcome
Changes in lipid profile
Time frame: baseline, week 4, week 8 and week 12
Measurement of lipid profile (HDL cholesterol, triglyceride levels)
Changes in glycemic profile
Time frame: baseline, week 4, week 8 and week 12
Measurement of fasting glucose, insulin, and calculation of HOMA-IR
Changes in gut microbiota
Time frame: week 0- week 12
Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)
10 secondary outcomes
Changes in Inflammatory Parametres
Time frame: baseline and week 12
Changes in serum cholesterol levels
Time frame: baseline, week 4, week 8 and week 12
Changes in triglycerides
Time frame: baseline, week 4, week 8 and week 12
Changes in lipoproteins
Time frame: baseline and week 12
Changes in homocysteine
Time frame: baseline and week 12
Changes in glycated hemoglobin
Time frame: baseline and week 12
Changes in blood pressure
Time frame: baseline, week 4, week 8 and week 12
Changes in waist circumference
Time frame: baseline, week 4, week 8 and week 12
Changes in Body Fat
Time frame: baseline, week 4, week 8 and week 12
Changes in BMI
Time frame: baseline, week 4, week 8 and week 12
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 29 May 2019.
- Derived from this study: PubMed 35405603Bellikci-Koyu E, Sarer-Yurekli BP, Karagozlu C, Aydin-Kose F, Ozgen AG, Buyuktuncer Z. Probiotic kefir consumption improves serum apolipoprotein A1 levels in metabolic syndrome patients: a randomized controlled clinical trial. Nutr Res. 2022 Jun;102:59-70. doi: 10.1016/j.nutres.2022.02.006. Epub 2022 Mar 7.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Kefir and Milk in people with Metabolic Syndrome and Obesity, run by Izmir Katip Celebi University.
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 2 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in lipid profile (time frame: baseline, week 4, week 8 and week 12). The study lists 3 primary outcomes in all. 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 NCT03966846, which also lists 1 linked publication.
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 29 May 2019.