Clinical trial NCT03312660: Effect of a Kefir Beverage on Immunity and Lipid Profile
Official title: Effect of a Kefir Beverage on Immunity and Lipid Profile: An Exploratory Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prebiotics
Keywords: Prebiotics
kefir
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2017-10-18
Enrollment: 158
Sex: ALL
Minimum age (years): 3
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Th17 cell counts in peripheral blood
timeFrame: 4 months
measure: Change from baseline in CD4 positive regulatory T cell counts in peripheral blood
timeFrame: 4 months
measure: Change from baseline in Th1 cell counts in peripheral blood
timeFrame: 4 months
measure: Change from baseline in Th2 cell counts in peripheral blood
timeFrame: 4 months
Secondary outcomes:
measure: Change from baseline in total cholesterol
timeFrame: 4 months
measure: Change from baseline in HDL cholesterol
timeFrame: 4 months
measure: Change from baseline in LDL cholesterol
timeFrame: 4 months
measure: Change from baseline in triglycerides
timeFrame: 4 months
measure: Change from baseline in allergic sensitization measured through a battery of 11 skin prick test to common allergens
timeFrame: 4 months
measure: Change from baseline in B lymphocytes in peripheral blood
timeFrame: 4 months
measure: Change from baseline in T lymphocytes in peripheral blood
timeFrame: 4 months
measure: Change from baseline in Natural Killer (NK) lymphocytes in peripheral blood
timeFrame: 4 months
measure: Change from baseline in C-reactive protein
timeFrame: 4 months
measure: Change from baseline in interleukin-6
timeFrame: 4 months
measure: Change from baseline in tumor necrosis factor-alpha
timeFrame: 4 months
measure: Change from baseline in glucose
timeFrame: 4 months
measure: Change from baseline in HbA1c
timeFrame: 4 months
measure: Change from baseline in insulin
timeFrame: 4 months
measure: Change from baseline in body mass index (BMI)
timeFrame: 4 months
measure: Change from baseline in waist circumference
timeFrame: 4 months
measure: Change from baseline in hip circumference
timeFrame: 4 months
measure: Change from baseline in stool frequency
timeFrame: 4 months
measure: Change from baseline in stool consistency (Bristol Stool Form Scale score)
timeFrame: 4 months
measure: Change from baseline in food intake over the last 4 weeks
timeFrame: 4 months
Other outcomes:
Locations:
city: A Estrada
country: Spain
facility: A Estrada Primary Care Centre
state: Pontevedra
Study officials:
affiliation: Clinic University Hospital of Santiago, Santiago de Compostela, Spain.
name: Mar Calvo-Malvar, PhD
role: STUDY_CHAIR
References: