Prebiotics Clinical Trial
Official title:
Effect of a Kefir Beverage on Immunity and Lipid Profile: An Exploratory Cluster Randomized Controlled Trial
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.
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