A Estrada Primary Care Centre
A Estrada, Pontevedra, 36680, Spain
NCT Number: NCT03312660
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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Notify Me3 year–85 year
All sexes
Interventional
Not applicable
A Estrada, Pontevedra, 36680, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
for the index subject and the other family members:
Fermented dairy product with galacto-oligosaccharides (GOS), kefiran and other metabolites resulting from the fermentation with kefir granules.
Other names: Fermented dairy product with kefir granules
Beverage with color, flavor and nutritional composition similar to the fermented dairy product but not containing the prebiotic components.
Other names: Dairy product without prebiotic components
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)
Time frame: 4 months
Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)
Time frame: 4 months
Estimated using the Friedewald formula. Enzymatic method when triglycerides > 400 mg/dl.
Time frame: 4 months
Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)
Time frame: 4 months
Cases with at least one positive test will be considered to have allergic sensitization.
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Flow cytometry analysis on peripheral blood
Time frame: 4 months
Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System
Time frame: 4 months
Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System
Time frame: 4 months
Immunometric chemoluminiscence method employing an Immulite 1000 Immunoassay System
Time frame: 4 months
Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)
Time frame: 4 months
High resolution liquid chromatography using a Menarini Diagnostics HA-8160 Analyzer;
Time frame: 4 months
Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System
Time frame: 4 months
BMI will be calculated as body weight (kg) divided by height (m) squared. The BMI of subjects under 18 years of age will be standardised using World Health Organization (WHO) reference data.
Time frame: 4 months
Waist circumference will be measured at the narrowest point between the bottom rib and the top of the iliac crest.
Time frame: 4 months
Hip circumference will be measured at the point of greatest prominence of the gluteal muscles.
Time frame: 4 months
Evaluated through a questionnaire.
Time frame: 4 months
Bristol Stool Form Scale (BSFS) is for classifying the form of stool into 7 categories scored from 1 to 7; (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid. Subjects choose one of the BSFS scores which has a nearest analog form with their stools at every defecation.
Types 1 and 2 are considered to be abnormally hard stools, while Types 6 and 7 are considered abnormally liquid stools. Types 3, 4 and 5 are generally considered to be the most normal stool forms.
Time frame: 4 months
Assessed using a semi-quantitative food frequency questionnaire (FFQ) which include 93 foods and drinks habitually consumed in Spain.
Hospital Clinico Universitario de Santiago
Other
Effect of a Kefir Beverage on Immunity and Lipid Profile: An Exploratory Cluster Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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