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
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Cardiovascular Diseases Hypertension||Dietary Supplement: probiotic milk fermented with kefir grains Dietary Supplement: curd||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|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.|
|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|
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.
- 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.
- 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