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Kefir and Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE August 28, 2018
Last Update Posted Date August 28, 2018
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • 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/.
  • Glycosylated hemoglobin [ Time Frame: 11 weeks ]
    measurement of glycosylated hemoglobin in blood samples
  • Oxidized LDL-cholesterol [ Time Frame: 11 weeks ]
    It has been considered a marker of development of atherosclerosis
  • Lipid profile [ Time Frame: 11 weeks ]
    measurement of total cholesterol and fractions in the blood samples
  • Blood glucose [ Time Frame: 11 weeks ]
    measurement of glucose and fractions in the blood samples
  • Blood pressure [ Time Frame: 11 weeks ]
    indirect measurement of systolic and diastolic arterial pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kefir and Metabolic Syndrome
Official Title  ICMJE USE OF KEFIR AS A CO-ADJUVANT IN THE TREATMENT OF METABOLIC SYNDROME COMPONENTS: a Double-blind, Randomized, Placebo Controlled Clinical Trial
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.
Detailed Description This is a randomized, double-blind clinical trial with stealth allocation through an automated randomization system Random Allocation Software version 1.0, May 2004. The randomization codes were the responsibility of the professional supervisor of the Laboratory of Technique and Dietetics of the University Vila Velha - UVV / ES. The same professional was responsible for the identification of bottled beverages intended for volunteers. Double blind refers to the blinding of patients, researcher, data collectors and outcome assessors. The kefir group (KG) received orally probiotic milk fermented with kefir grains and the control group (CG) received curds. The follow-up of the clinical trial is classified as long-term as it lasted for eleven weeks. The subjects of the research were recruited in an university teaching institution. After recruitment, confirmation of the presence of MS parameters was performed through anthropometric analyzes, blood pressure measurement and biochemical parameters, following the NCEP-ATP-III criteria. The subjects were then randomized into two groups, the control (CG) and kefir (KG). After the 11-week period all analyzes performed before the randomization process were repeated. During the study the drugs for the reduction of serum cholesterol, arterial hypertension and any other medication of continuous use had their use maintained. The inclusion criteria were age above 18 years and having had alteration of the components of MS. Pregnant and lactating women were excluded from the study, those who used drugs for dyslipidemias that interfered with intestinal metabolism such as ezetimibe and anion exchange resin, hormones of any kind, medicines for weight loss and the use of antioxidant supplements such as vitamin C or ω-3. The present work was submitted and approved by the Ethics Committee in Research with Human Subjects of the University Vila Velha - UVV, under number 1,025,083. All the volunteers signed the free and informed consent form, agreeing to participate in the research. The sample was calculated to detect a 12% reduction in the levels of ultra-sensitive C-reactive protein (CRP), considering a standard deviation of 15% a 2-tailed of 0.5 and power of 80%. The products were distributed to the volunteers in the workplace during office hours, in the morning, Monday to Friday. The routine was followed daily, totaling eleven weeks of experiment. The anthropometric measurements were individually assessed at the UVV Nutrition Clinic before the beginning of the trial and were repeated at the end of the study. In order to measure body weight, the RAMUZA DP-300 digital platform scale was used with a maximum capacity of 200 kg and a precision of 100 g. The measurements were performed with light clothing and with barefoot volunteers. The stature was measured using the CHORDER HM 210D digital vertical anthropometry, maximum measurement of 210 cm and precision of 1mm, with barefoot individuals. For the calculation and classification of the body mass index (BMI), the cuts proposed by the WHO were adopted. The waist circumference (WC) was obtained by means of a millimeter and inelastic measuring tape. The cut-off points for risk assessment associated with metabolic complications of obesity were proposed according to WHO and SIMÃO et al. (2013). Body composition was analyzed by electrical bioimpedance (MaltronBody Fat Analyzer BF 906), as described by Lukaski et al. (1985). The percentage of lean mass and body fat was evaluated. During the experiment the food selection was at the discretion of the volunteer, following the composition and distribution of the meals they usually consume. The blood pressure measurement (SBP and DBP) was performed according to the protocol of the Sixth Brazilian Hypertension Guideline, using the average between two measurements performed using HEM-705CPINT automatic device, Omron, OmronHealth Care, INC., Illinois-USA. For biochemical analysis, fasting blood samples were collected by traditional venipuncture to evaluate the biochemical parameters of fasting glycemia, glycated hemoglobin (HA1c), total cholesterol (TC), high density lipoprotein (HDLc), triglycerides (Tg) (C-reactive protein), C-reactive protein (CRP), low-oxidized lipoprotein (LDLox), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatinophosphokinase (CPK), γ-Glutamyl Transferase (γ-GT), Urea Nitrogen, Creatinine. The samples were sent to the Tommasi Clinical Analysis Laboratory - Vila Velha - ES, for further analysis. Low Density Lipoprotein (LDLc) and Non-HDLc Cholesterol were calculated from the biochemical analysis of the blood. To identify the relative and absolute risk of each volunteer from the research for the development of coronary disease in the next decade of life, it was applied the Framingham score for the risk of coronary heart disease. All data from anthropometry, food intake, biochemical analysis of blood, SBP and DBP, and Framinghan score were collected before and after the period of consumption of curd or kefir products. The data was compiled in spreadsheet elaborated in Microsoft Excel and were expressed as the average plus or minus standard deviation (S.D.). The database was analyzed using the statistical program SPSS 11.5 (Statiscal Package Social Science version 11.5). Simple relative frequencies were performed for qualitative variables within each group. For the quantitative data, descriptive statistics were performed and the differences were determined using the paired Student's T test (in the same group) and unpaired (between the groups) for a 95% confidence interval. The difference between means will be considered when p <0.05.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Metabolic Syndrome
  • Cardiovascular Diseases
  • Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: probiotic milk fermented with kefir grains
  • Experimental: control group
    control group (CG) that received only curd
    Intervention: Dietary Supplement: curd
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2018)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03649828
Other Study ID Numbers  ICMJE 43028115.8.0000.5064
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Vila Velha
Study Sponsor  ICMJE University Vila Velha
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Vila Velha
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP