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Kefir and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03649828
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Vila Velha

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Cardiovascular Diseases Hypertension Dietary Supplement: probiotic milk fermented with kefir grains Dietary Supplement: curd Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: USE OF KEFIR AS A CO-ADJUVANT IN THE TREATMENT OF METABOLIC SYNDROME COMPONENTS: a Double-blind, Randomized, Placebo Controlled Clinical Trial
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine


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
Dietary Supplement: probiotic milk fermented with kefir grains
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
Dietary Supplement: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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/.


  2. Glycosylated hemoglobin [ Time Frame: 11 weeks ]
    measurement of glycosylated hemoglobin in blood samples

  3. Oxidized LDL-cholesterol [ Time Frame: 11 weeks ]
    It has been considered a marker of development of atherosclerosis

  4. Lipid profile [ Time Frame: 11 weeks ]
    measurement of total cholesterol and fractions in the blood samples

  5. Blood glucose [ Time Frame: 11 weeks ]
    measurement of glucose and fractions in the blood samples

  6. Blood pressure [ Time Frame: 11 weeks ]
    indirect measurement of systolic and diastolic arterial pressure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Publications:
Simão 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, Brandão AA, Sanjuliani AF, Sbissa AS, Alencar FA, Herdy AH, Polanczyk CA, Lantieri CJ, Machado CA, Scherr C, Stoll C, Amodeo C, Araújo 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, Magalhães 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. Portuguese. Erratum in: Arq Bras Cardiol. 2014 Apr;102(4):415. Cesena, F H Y [removed].

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Responsible Party: University Vila Velha
ClinicalTrials.gov Identifier: NCT03649828     History of Changes
Other Study ID Numbers: 43028115.8.0000.5064
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Vila Velha:
kefir
Probiotics
Metabolic Syndrome
Cardiovascular Diseases
Hypertension
Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Syndrome
Cardiovascular Diseases
Disease
Pathologic Processes
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases