Effect of a Kefir Beverage on Immunity and Lipid Profile

Hospital Clinico Universitario de Santiago158 enrolled

Overview

This is an exploratory cluster randomized controlled trial to evaluate the effect of a kefir beverage, enriched with prebiotics components, on immunity, lipid profile and adiposity in a population-based study, using the family as the intervention unit.

The gastrointestinal tract is populated by a collection of microorganisms, primarily bacteria, that interact with intestinal host cells. In the past two decades, several studies have demonstrated the effects of the intestinal microbiota on host physiological, metabolic and immunological processes and have revealed that the microbiota is fundamental to host body function. There is currently a growing interest in manipulating the intestinal microbiota to enhance the effects on health and welfare of the intestine. In this regard, since its introduction, the concept of prebiotics has stimulated both scientific and industrial interest. A dietary prebiotic is a selectively fermented ingredient that results in specific changes, in the composition and/or activity of the gastrointestinal microbiota, thus conferring benefits upon host health. To date, the prebiotics most widely evaluated in human clinical trials are inulin-type fructans (inulin, fructo-oligosaccharides, oligofructose) and galacto-oligosaccharides (GOS). The investigators goal is to conduct a human clinical trial to evaluate the impacts of a functional-prebiotic beverage on immunity and metabolic profile. This study will be performed on a family-oriented basis. 44 families/clusters (\~ 150 children and adults, older than 3 years) will be selected to participate in the study and will be randomized into intervention group (n=22 families) and control (n=22 families) groups. Weight, body mass index (BMI), waist circumference (WC), nutrient intake from food frequency questionnaire, physical activity, blood pressure, allergic sensitization, metabolic function (fasting blood glucose, HbA1c, insulin resistance and lipid profile), general lymphocyte overview (B-cells, T-cells and NK-cells) and sub-populations of T-helper cells (Th1, Th2, Th17 and T-regulatory), inflammation markers (C-reactive protein, interleukin-6 and tumor necrosis factor-alpha) will be measured at baseline and after 4 months. Mixed effect models analysis will be performed to assess changes in the cardiometabolic and immune parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

158

Conditions

Prebiotics

Interventions

Prebiotic groupDIETARY_SUPPLEMENT

Fermented dairy product with galacto-oligosaccharides (GOS), kefiran and other metabolites resulting from the fermentation with kefir granules.

Placebo groupDIETARY_SUPPLEMENT

Beverage with color, flavor and nutritional composition similar to the fermented dairy product but not containing the prebiotic components.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. For the index subject: * Female or male. * 18 years and older. * Living in a family unit with two or more people. 2. For the other family members: * Female or male. * Age between 3 to 85 years. 3. At family level: at least two members will meet inclusion criteria but no exclusion criterion Exclusion Criteria for the index subject and the other family members: * Alcoholism * Pregnant * Major cardiovascular disease * Dementia * Major autoimmune diseases * Diseases or treatments that seriously affect the immune status * Neoplasia * Terminal disease

Locations (1)

A Estrada Primary Care Centre

A Estrada, Pontevedra, Spain

Outcomes

Primary Outcomes

Change from baseline in Th17 cell counts in peripheral blood

Flow cytometry analysis on peripheral blood

Time frame: 4 months

Change from baseline in CD4 positive regulatory T cell counts in peripheral blood

Flow cytometry analysis on peripheral blood

Time frame: 4 months

Change from baseline in Th1 cell counts in peripheral blood

Flow cytometry analysis on peripheral blood

Time frame: 4 months

Change from baseline in Th2 cell counts in peripheral blood

Flow cytometry analysis on peripheral blood

Time frame: 4 months

Secondary Outcomes

Change from baseline in total cholesterol

Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

Time frame: 4 months

Change from baseline in HDL cholesterol

Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

Time frame: 4 months

Change from baseline in LDL cholesterol

Estimated using the Friedewald formula. Enzymatic method when triglycerides \> 400 mg/dl.

Time frame: 4 months

Change from baseline in triglycerides

Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

Data from ClinicalTrials.gov

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