- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03649828
Kefir and Metabolic Syndrome
USE OF KEFIR AS A CO-ADJUVANT IN THE TREATMENT OF METABOLIC SYNDROME COMPONENTS: a Double-blind, Randomized, Placebo Controlled Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age above 18 years, and;
- The presence of at least three of the five components of the metabolic syndrome.
Exclusion Criteria:
- Pregnant and lactating women;
- Subjects under the use of drugs for dyslipidemias that interfere with intestinal metabolism such as ezetimibe and anion exchange resin;
- Subjects under use of any kind of hormones;
- Subjects under the use of drugs for weight loss;
- Subjects under the use of antioxidant supplements such as vitamin C or ω-3.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: kefir group
The kefir group (KG) received orally probiotic milk fermented with kefir grains and was compared with the control group (CG) that received only curd
|
Participants received probiotic milk fermented with kefir grains for consumption for 11 weeks.
Before and after treatment, blood samples were collected for biochemical analysis and anthropometric data were also evaluated.
|
Experimental: control group
control group (CG) that received only curd
|
Participants received the curd for consumption for 11 weeks.
Before and after treatment, blood samples were collected for biochemical analysis and anthropometric data were also evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultra-sensitive C reactive Protein
Time Frame: 11 weeks
|
Ultra-sensitive C reactive protein (uCRP) is a marker of cardiovascular risk. It is measured in blood samples and expressed in mg/dL. Therefore, the primary outcome was to evaluate the reduction of the cardiovascular risk. This measurement is stratified as bellow: Low cardiovascular risk: uCRP bellow 1.0 mg/dL; Medium cardiovascular risk: uCRP between 1.0 and 3.0 mg/dL; High cardiovascular risk: uCRP higher then 3.0 mg/dL. |
11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Framinghan score (the Coronay Heart Disease risk in 10 years)
Time Frame: 11 weeks
|
The CHD (ten years risk) score is based on a group of variables: a) age, b) total cholesterol or Low disunity lipoprotein cholesterol, c) High density lipoprotein cholesterol, e) blood pressure, f) the presence of diabetes, and g) the smoke behavior. For each variable, the subject receives punctuation. Then, these punctuations are summed, and according with this sum a percentage of risk to develop CHD in 10 years is given. How much high is the sum, higher is the CHD risk. For men it varies from the sum ≤ -1, with the related CHD risk of 2%; to sum ≥14, with the related CHD risk ≥ 53%. For women it varies from the sum ≤ -1, with the related CHD risk of 1%; to sum ≥17, with the related CHD risk ≥ 27%. The calculation of this score (CHD risk in 10 yr) can be performed online and is based on the site of Framingham Heart Study. Therefore, the details of the process can be assessed in https://www.framinghamheartstudy.org/fhs-risk-functions/coronary-heart-disease-10-year-risk/. |
11 weeks
|
Glycosylated hemoglobin
Time Frame: 11 weeks
|
measurement of glycosylated hemoglobin in blood samples
|
11 weeks
|
Oxidized LDL-cholesterol
Time Frame: 11 weeks
|
It has been considered a marker of development of atherosclerosis
|
11 weeks
|
Lipid profile
Time Frame: 11 weeks
|
measurement of total cholesterol and fractions in the blood samples
|
11 weeks
|
Blood glucose
Time Frame: 11 weeks
|
measurement of glucose and fractions in the blood samples
|
11 weeks
|
Blood pressure
Time Frame: 11 weeks
|
indirect measurement of systolic and diastolic arterial pressure
|
11 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
- Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO 3rd, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511. doi: 10.1161/01.cir.0000052939.59093.45. No abstract available.
- Lukaski HC, Johnson PE, Bolonchuk WW, Lykken GI. Assessment of fat-free mass using bioelectrical impedance measurements of the human body. Am J Clin Nutr. 1985 Apr;41(4):810-7. doi: 10.1093/ajcn/41.4.810.
- Simao AF, Precoma DB, Andrade JP, Correa FH, Saraiva JF, Oliveira GM, Murro AL, Campos A, Alessi A, Avezum A Jr, Achutti AC, Miguel AC, Sousa AC, Lotemberg AM, Lins AP, Falud AA, Brandao AA, Sanjuliani AF, Sbissa AS, Alencar FA, Herdy AH, Polanczyk CA, Lantieri CJ, Machado CA, Scherr C, Stoll C, Amodeo C, Araujo CG, Saraiva D, Moriguchi EH, Mesquita ET, Fonseca FA, Campos GP, Soares GP, Feitosa GS, Xavier HT, Castro I, Giuliano IC, Rivera IV, Guimaraes IC, Issa JS, Souza JR, Faria NJ, Cunha LB, Pellanda LC, Bortolotto LA, Bertolami MC, Miname MH, Gomes MA, Tambascia M, Malachias MV, Silva MA, Izar MC, Magalhaes ME, Bacellar MS, Milani M, Wajngarten M, Ghorayeb N, Coelho OR, Villela PB, Jardim PC, Santos Filho RD, Stein R, Cassani RS, D'Avila RI, Ferreira RM, Barbosa RB, Povoa RM, Kaiser SE, Ismael SC, Carvalho T, Giraldez VZ, Coutinho W, Souza WK; Sociedade Brasileira de Cardiologia. [I Brazilian Guidelines for cardiovascular prevention]. Arq Bras Cardiol. 2013 Dec;101(6 Suppl 2):1-63. doi: 10.5935/abc.2013S012. No abstract available. Erratum In: Arq Bras Cardiol. 2014 Apr;102(4):415. Cesena, F H Y [removed]. Portuguese.
- Kumar M, Nagpal R, Kumar R, Hemalatha R, Verma V, Kumar A, Chakraborty C, Singh B, Marotta F, Jain S, Yadav H. Cholesterol-lowering probiotics as potential biotherapeutics for metabolic diseases. Exp Diabetes Res. 2012;2012:902917. doi: 10.1155/2012/902917. Epub 2012 May 3. Erratum In: J Diabetes Res. 2022 Apr 1;2022:3952529.
- Labonte ME, Dewailly E, Lucas M, Couture P, Lamarche B. Association of red blood cell n-3 polyunsaturated fatty acids with plasma inflammatory biomarkers among the Quebec Cree population. Eur J Clin Nutr. 2014 Sep;68(9):1042-7. doi: 10.1038/ejcn.2014.125. Epub 2014 Jul 16.
- Friques AG, Arpini CM, Kalil IC, Gava AL, Leal MA, Porto ML, Nogueira BV, Dias AT, Andrade TU, Pereira TM, Meyrelles SS, Campagnaro BP, Vasquez EC. Chronic administration of the probiotic kefir improves the endothelial function in spontaneously hypertensive rats. J Transl Med. 2015 Dec 30;13:390. doi: 10.1186/s12967-015-0759-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43028115.8.0000.5064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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