Effect of a Kefir Beverage on Immunity and Lipid Profile

NCT03312660 | Completed

• 1 other identifier: INNTER BIOFUNCIOGAL 2015
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Prebiotics

Keywords

Prebiotics; kefir

Outcome Measures

Primary Outcomes (4)

• Change from baseline in Th17 cell counts in peripheral blood

  Flow cytometry analysis on peripheral blood

  4 months

• Change from baseline in CD4 positive regulatory T cell counts in peripheral blood

  Flow cytometry analysis on peripheral blood

  4 months

• Change from baseline in Th1 cell counts in peripheral blood

  Flow cytometry analysis on peripheral blood

  4 months

• Change from baseline in Th2 cell counts in peripheral blood

  Flow cytometry analysis on peripheral blood

  4 months

Secondary Outcomes (20)

• Change from baseline in total cholesterol

  4 months

• Change from baseline in HDL cholesterol

  4 months

• Change from baseline in LDL cholesterol

  4 months

• Change from baseline in triglycerides

  4 months

• Change from baseline in allergic sensitization measured through a battery of 11 skin prick test to common allergens

  4 months

Study Arms (2)

Prebiotic group.

EXPERIMENTAL

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

Dietary Supplement: Prebiotic group

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo group

Interventions

Prebiotic group DIETARY_SUPPLEMENT

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

Also known as: Fermented dairy product with kefir granules

Prebiotic group.

Placebo group DIETARY_SUPPLEMENT

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

Also known as: Dairy product without prebiotic components

Placebo group

Eligibility Criteria

• Age: 3 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For the index subject:
• Female or male.
• years and older.
• Living in a family unit with two or more people.
• For the other family members:
• Female or male.
• Age between 3 to 85 years.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

A Estrada Primary Care Centre

A Estrada, Pontevedra, 36680, Spain

Location

MeSH Terms

Interventions

Cultured Milk Products; Dairy Products

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Food; Food and Beverages

Study Officials

• Mar Calvo-Malvar, PhD

  Clinic University Hospital of Santiago, Santiago de Compostela, Spain.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 18, 2017
• Study Start: April 10, 2017
• Primary Completion: November 23, 2017
• Study Completion: November 27, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)