Effect of a Kefir Beverage on Immunity and Lipid Profile

Prebiotics Clinical Trial

Official title:

Effect of a Kefir Beverage on Immunity and Lipid Profile: An Exploratory Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312660
• Other study ID #: INNTER BIOFUNCIOGAL 2015
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: March 2, 2018
• Start date: April 10, 2017
• Est. completion date: November 27, 2017

Study information

• Verified date: March 2018
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 27, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Prebiotics

Intervention

Dietary Supplement:
• Prebiotic group
Fermented dairy product with galacto-oligosaccharides (GOS), kefiran and other metabolites resulting from the fermentation with kefir granules.
• Placebo group
Beverage with color, flavor and nutritional composition similar to the fermented dairy product but not containing the prebiotic components.

Locations

Country	Name	City	State
Spain	A Estrada Primary Care Centre	A Estrada	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago	Centre for the Development of Industrial Technology (CDTI)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Th17 cell counts in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Primary	Change from baseline in CD4 positive regulatory T cell counts in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Primary	Change from baseline in Th1 cell counts in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Primary	Change from baseline in Th2 cell counts in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Secondary	Change from baseline in total cholesterol	Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)	4 months
Secondary	Change from baseline in HDL cholesterol	Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)	4 months
Secondary	Change from baseline in LDL cholesterol	Estimated using the Friedewald formula. Enzymatic method when triglycerides > 400 mg/dl.	4 months
Secondary	Change from baseline in triglycerides	Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)	4 months
Secondary	Change from baseline in allergic sensitization measured through a battery of 11 skin prick test to common allergens	Cases with at least one positive test will be considered to have allergic sensitization.	4 months
Secondary	Change from baseline in B lymphocytes in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Secondary	Change from baseline in T lymphocytes in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Secondary	Change from baseline in Natural Killer (NK) lymphocytes in peripheral blood	Flow cytometry analysis on peripheral blood	4 months
Secondary	Change from baseline in C-reactive protein	Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System	4 months
Secondary	Change from baseline in interleukin-6	Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System	4 months
Secondary	Change from baseline in tumor necrosis factor-alpha	Immunometric chemoluminiscence method employing an Immulite 1000 Immunoassay System	4 months
Secondary	Change from baseline in glucose	Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)	4 months
Secondary	Change from baseline in HbA1c	High resolution liquid chromatography using a Menarini Diagnostics HA-8160 Analyzer;	4 months
Secondary	Change from baseline in insulin	Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System	4 months
Secondary	Change from baseline in body mass index (BMI)	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.	4 months
Secondary	Change from baseline in waist circumference	Waist circumference will be measured at the narrowest point between the bottom rib and the top of the iliac crest.	4 months
Secondary	Change from baseline in hip circumference	Hip circumference will be measured at the point of greatest prominence of the gluteal muscles.	4 months
Secondary	Change from baseline in stool frequency	Evaluated through a questionnaire.	4 months
Secondary	Change from baseline in stool consistency (Bristol Stool Form Scale score)	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.	4 months
Secondary	Change from baseline in food intake over the last 4 weeks	Assessed using a semi-quantitative food frequency questionnaire (FFQ) which include 93 foods and drinks habitually consumed in Spain.	4 months