Effect of a Kefir Beverage on Immunity and Lipid Profile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2017-11-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prebiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Both groups will receive fermented dairy products with similar color, flavor and nutritional composition, except the prebiotic components, which will only be administered to the intervention group.

Study Groups

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Prebiotic group.

Group of 22 families consuming a fermented dairy product with prebiotic components, once a day for 4 months.

Group Type EXPERIMENTAL

Prebiotic group

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

Group of 22 families consuming a dairy product with similar characteristics regarding color, flavor and nutritional composition, not containing the prebiotic components, once a day for 4 months.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Prebiotic group

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

Intervention Type DIETARY_SUPPLEMENT

Placebo group

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fermented dairy product with kefir granules Dairy product without prebiotic components

Eligibility Criteria

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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.

Exclusion Criteria

* Alcoholism
* Pregnant
* Major cardiovascular disease
* Dementia
* Major autoimmune diseases
* Diseases or treatments that seriously affect the immune status
* Neoplasia
* Terminal disease

Minimum Eligible Age

3 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No