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PrebioticsNCT03312660

Effect of a Kefir Beverage on Immunity and Lipid Profile

A study testing Prebiotic group in people with Prebiotics, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 85 years
Conditions the study is for
Prebiotics
What is being tested?
Prebiotic group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
1 siteSpain
Study dates
10 Apr 2017to 27 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • For the index subject:
  • Female or male.
  • 18 years and older.
  • Living in a family unit with two or more people.
  • For the other family members:
  • Female or male.
Show all 17Show fewer
  • Age between 3 to 85 years.
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • A Estrada Primary Care Centre

    A Estrada, Pontevedra, 36680

Other trials in Spain

About this study

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.

Read the 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.

Conditions
Prebiotics
Being tested
Prebiotic group, Placebo group
Keywords
Prebiotics, kefir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prebiotic groupDietary supplement

    Also called Fermented dairy product with kefir granules

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

  • Placebo groupDietary supplement

    Also called Dairy product without prebiotic components

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

Study groups in NCT03312660
Study groupRoleWhat they receive
Prebiotic group.ExperimentalGroup of 22 families consuming a fermented dairy product with prebiotic components, once a day for 4 months.
Receives: Dietary Supplement: Prebiotic group
Placebo groupPlacebo comparatorGroup 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.
Receives: Dietary Supplement: Placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Th17 cell counts in peripheral blood

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

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

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

  3. Change from baseline in Th1 cell counts in peripheral blood

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

  4. Change from baseline in Th2 cell counts in peripheral blood

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

Secondary outcomes (20)

  1. Change from baseline in total cholesterol

    Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

    Measured: 4 months

  2. Change from baseline in HDL cholesterol

    Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

    Measured: 4 months

  3. Change from baseline in LDL cholesterol

    Estimated using the Friedewald formula. Enzymatic method when triglycerides > 400 mg/dl.

    Measured: 4 months

  4. Change from baseline in triglycerides

    Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

    Measured: 4 months

  5. 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.

    Measured: 4 months

  6. Change from baseline in B lymphocytes in peripheral blood

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

  7. Change from baseline in T lymphocytes in peripheral blood

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

  8. Change from baseline in Natural Killer (NK) lymphocytes in peripheral blood

    Flow cytometry analysis on peripheral blood

    Measured: 4 months

  9. Change from baseline in C-reactive protein

    Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System

    Measured: 4 months

  10. Change from baseline in interleukin-6

    Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System

    Measured: 4 months

  11. Change from baseline in tumor necrosis factor-alpha

    Immunometric chemoluminiscence method employing an Immulite 1000 Immunoassay System

    Measured: 4 months

  12. Change from baseline in glucose

    Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)

    Measured: 4 months

  13. Change from baseline in HbA1c

    High resolution liquid chromatography using a Menarini Diagnostics HA-8160 Analyzer;

    Measured: 4 months

  14. Change from baseline in insulin

    Immunometric chemoluminiscence method employing an Immulite 2000 Immunoassay System

    Measured: 4 months

  15. 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.

    Measured: 4 months

  16. 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.

    Measured: 4 months

  17. Change from baseline in hip circumference

    Hip circumference will be measured at the point of greatest prominence of the gluteal muscles.

    Measured: 4 months

  18. Change from baseline in stool frequency

    Evaluated through a questionnaire.

    Measured: 4 months

  19. 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.

    Measured: 4 months

  20. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2017
  2. Study start10 Apr 2017
  3. Primary completion23 Nov 2017
  4. Study completion27 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03312660
Sponsor's protocol ID
INNTER BIOFUNCIOGAL 2015
Status last verified
Mar 2018
First submitted
4 Oct 2017
Last updated
5 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic group in people with Prebiotics, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Th17 cell counts in peripheral blood (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03312660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.

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