Kefir and Metabolic Syndrome

NCT03649828 | Completed DMC

• 1 other identifier: 43028115.8.0000.5064
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Metabolic Syndrome (MS) contributes to the development of cardiovascular diseases (CVD). According to the World Health Organization (WHO), CVDs are the leading causes of death in the world. According to epidemiological data from the Ministry of Health, these diseases account for 29.4% of all deaths recorded in Brazil annually. Kefir is obtained by fermenting milk with kefir grains and has been recommended as a therapeutic form for the treatment of various clinical conditions. The hypothesis of the present study is that the daily intake of fermented beverages with kefir grains may reduce the risk factors associated with MS, thus reducing the incidence of CVD. A clinical trial was conducted with 48 volunteers, who presented at least three criteria for the diagnosis of MS. The subjects were divided into two groups that received for eleven weeks fermented dairy drink with kefir (KG) grains or homemade curd (CG). Weight and height measurements were taken to calculate BMI. The body composition evaluation was performed by determining the percentage of body fat and waist circumference (WC). The measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken. Blood samples were analyzed for fasting glycemia, glycated hemoglobin (HA1c), total cholesterol (TC), HDL cholesterol, triglycerides (Tg), C-reactive protein (CRP), aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatinophosphokinase (CPK), γ-Glutamyl Transferase (γ-GT), Urea Nitrogen, Urea and Creatinine. The level of non-HDL cholesterol (n-HDL) was determined by calculation. The Framingham score was used to assess the risk of developing cardiovascular events over the next ten years. Eleven weeks into the experiment, all measurements of body evaluation, SBP and DBP and biochemical analysis of blood were reevaluated.

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Hypertension

Keywords

kefir; Probiotics; Metabolic Syndrome; Cardiovascular Diseases; Hypertension

Outcome Measures

Primary Outcomes (1)

• Ultra-sensitive C reactive Protein

  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 Outcomes (6)

• Framinghan score (the Coronay Heart Disease risk in 10 years)

  11 weeks

• Glycosylated hemoglobin

  11 weeks

• Oxidized LDL-cholesterol

  11 weeks

• Lipid profile

  11 weeks

• Blood glucose

  11 weeks

Study Arms (2)

kefir group

EXPERIMENTAL

The kefir group (KG) received orally probiotic milk fermented with kefir grains and was compared with the control group (CG) that received only curd

Dietary Supplement: probiotic milk fermented with kefir grains

control group

EXPERIMENTAL

control group (CG) that received only curd

Dietary Supplement: curd

Interventions

probiotic milk fermented with kefir grains DIETARY_SUPPLEMENT

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.

kefir group

curd DIETARY_SUPPLEMENT

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years, and;
• The presence of at least three of the five components of the metabolic syndrome.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Vila Velha: lead

Related Publications (7)

• 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. Portuguese.

  PMID: 24554026 BACKGROUND

• 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.

  PMID: 12485966 BACKGROUND

• 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.

  PMID: 22611376 BACKGROUND

• 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.

  PMID: 25028086 BACKGROUND

• 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.

  PMID: 26715471 BACKGROUND

• 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.

  PMID: 3984933 BACKGROUND

• 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.

  PMID: 12551878 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Hypertension

Interventions

Kefir

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Milk; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both Kefir and curd had been prepared to have the same consistency, color and flavor. Therefore, participants did not know if they were actually receiving kefir or curd. The care provider was a nutritionist that did not from each group the participants came from. There was two major investigators. The investigator responsible for the analysis of the data was also blind to the experimental groups, and he was also the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There were two experimental groups. The kefir group (KG), that received orally probiotic milk fermented with the kefir grains, and the control group (CG), that received curd

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: August 28, 2018
• Study Start: July 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share