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Effect of Kefir on Healthy AdultsKefirConsNCT06612164

Effects of Kefir Consumption on Health Outcomes: Gastrointestinal System, Immunity, Biochemical Parameters, Body Composition, Sleep Quality and Mental Well Being in Healthy Adults

A study testing kefir in people with Effect of Kefir on Healthy Adults, run by Medipol University at 1 site in Turkey (Türkiye).

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

The goal of this clinical trial is to evaluate the effects of the administration of kefir on gastrointestinal system, mental health, biochemical parameters, immunity and inflammation processes as well as the sleep quality, elucidating the possible health effects of kefir consumption in healthy adults. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Effect of Kefir on Healthy Adults
What is being tested?
kefir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2023to 30 Jun 2023
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 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Volunteer to consume 250 mL of plain lactose-free kefir once a day,
  • Being healthy
  • Being 18-35 years of age.

Who cannot join

  • Follow a special diet for health reasons,
  • Have an allergy to any food, have hepatic, renal and biliary diseases, have immunodeficiency, autoimmune and chronic gastrointestinal diseases, have a history of cancer, diabetes or cardiovascular diseases,
  • Being pregnant/breastfeeding,
  • Using vitamin-mineral and probiotic supplements,
  • Using antibiotics in last one month and throughout the study period,
  • Consuming probiotic foods or kefir on a regular basis,
  • Smoking

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Beykoz, 34815

Other trials in Turkey (Türkiye)

About this study

The goal of this clinical trial is to evaluate the effects of the administration of kefir on gastrointestinal system, mental health, biochemical parameters, immunity and inflammation processes as well as the sleep quality, elucidating the possible health effects of kefir consumption in healthy adults. The main questions it aims to answer are:

  1. Will be better the gastrointestinal system symptoms severity of volunteers in the intervention group will be better compared to the control group?
  2. Will be better the mental health status of volunteers in the intervention group will be better compared to the control group?
  3. Will be better the biochemical parameters of volunteers in the intervention group will be better compared to the control group?
  4. Will be better the immunity and inflammation processes of volunteers in the intervention group will be better compared to the control group?

The participants were asked to consume 250 mL of plain lactose-free kefir daily for 6 weeks. Any particular time was not specified for kefir consumption. Kefir consumption routine of participants was followed up by regular phone calls every week and evaluated by examining their consumption records. Those who consumed less than 85.0% (skipping kefir consumption maximum once a week) of the planned kefir consumption during the study period were excluded from the study.

Read the detailed description

In order to evaluate the general characteristics, history of diseases and nutritional behaviors, a face-to-face questionnaire was conducted on all participants by the researchers. The questionnaire form contained information about the demographic information (age, gender, educational status, marital status, etc.), history of diseases (diagnosed diseases, drugs used etc.), basic nutritional habits (number of major meals/snacks consumed in a day, water consumption, etc.) and anthropometric measurements (body weight, height, body mass index, waist circumference, neck circumference). In the intial (pre-intervention) and final (post-intervention) stages of the study, anthropometric measurements of the participants were taken, and body composition analysis was done. In addition, biochemical findings and 3-day food consumption records were taken in the intial (pre-intervention) and final (post-intervention) stages of the study. Effects of kefir consumption on gastrointestinal system, biochemical findings, mental health, immunity and inflammation, sleep quality, was evaluated by assessment of the relevant status of participants before and after kefir intervention and comparison with the control group. Short Physical Activity Assessment Tool was used for evaluating physical activity levels of the participants, mental health status by The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Gastrointestinal system symptoms were evaluated by using the Gastrointestinal Symptom Rating Scale (GSRS), sleep quality by the Pittsburg Sleep Quality Index (PSQI) and diet quality by the Healthy Eating Index-2015 (HEI-2015). Measurements were recorded prior to kefir intervention (initial measurement) and post kefir intervention (final measurement) for kefir and control groups.

Being tested
kefir
Keywords
gastrointestinal symptoms, immunity, kefir, mental health, sleep quality, body composition
Medical subject headings
Psychological Well-Being, Sleep Initiation and Maintenance Disorders

What participants receive

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

  • kefirOther

    Commercial lactose-free kefir (Altinkilic, Turkey) beverage, which is produced from cow milk with 3.1% fat and 7.5% protein content and stored in appropriate conditions, was used in this study. The kefir (intervention) group was provided with 250 mL of plain lactose-free kefir containing at least 107-1010 probiotic bacterial strains (Lactobacillus, Lactic acid, Streptococcus, Acetic acid bacteria sp) and yeasts (Kluyveromyces marxianus, Torulaspora delbrueckii, Saccharomyces cerevisiae, Candida). The participants were asked to consume 250 mL of plain lactose-free kefir daily for 6 weeks. Any particular time was not specified for kefir consumption. Kefir consumption routine of participants was followed up by regular phone calls every week and evaluated by examining their consumption records. Those who consumed less than 85.0% (skipping kefir consumption maximum once a week) of the planned kefir consumption during the study period were excluded from the study.

Study groups in NCT06612164
Study groupRoleWhat they receive
Kefir Consumption GroupExperimentalCommercial lactose-free kefir (Altinkilic, Turkey) beverage, which is produced from cow milk with 3.1% fat and 7.5% protein content and stored in appropriate conditions, was used in this study. The kefir (intervention) group was provided with 250 mL of plain lactose-free kefir containing at least 107-1010 probiotic bacterial strains (Lactobacillus, Lactic acid, Streptococcus, Acetic acid bacteria sp) and yeasts (Kluyveromyces marxianus, Torulaspora delbrueckii, Saccharomyces cerevisiae, Candida). The participants were asked to consume 250 mL of plain lactose-free kefir daily for 6 weeks. Any particular time was not specified for kefir consumption. Kefir consumption routine of participants was followed up by regular phone calls every week and evaluated by examining their consumption records.
Receives: Other: kefir
Control GroupNo interventionShort Physical Activity Assessment Tool was used for evaluating physical activity levels of the participants, mental health status by The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Gastrointestinal system symptoms were evaluated by using the Gastrointestinal Symptom Rating Scale (GSRS), sleep quality by the Pittsburg Sleep Quality Index (PSQI) and diet quality by the Healthy Eating Index-2015 (HEI-2015). Measurements were recorded prior to kefir intervention (initial measurement) and post kefir intervention (final measurement) for kefir and control groups.

What is being measured

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

  1. Evaluation of Gastrointestinal Health

    Gastrointestinal Symptom Rating Scale developed by Revicki et al and validated in Turkish by Turan et al. (2017) was used to evaluate gastrointestinal health of participants. GSRS is a disease specific instrument comprising of 15 items combined into 5 symptom clusters namely abdominal pain (items 1, 4 and 5), reflux (items 2 and 3), indigestion (items 6, 7, 8 and 9), diarrhea (items 11,12 and 14) and constipation (items 10, 13 and 15). In order to score the items, participants state how he/she felt about these problems in the past week. GSRS questions are rated on a 7-point Likert scale ranging from \"no discomfort\" to \"very severe discomfort\". A score of 1 is given for the absence of symptoms, and 7 for frequent and severe symptoms. High scores indicate severity of symptoms and diseased state.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. Body Composition and Anthropometric Measurements

    Body composition analysis, of the participants, was performed with TANITA MC-780 body composition analyser. By means of bioelectrical impedance analysis, basal metabolic rate and body composition (fat mass, muscle mass, fluid mass, lean mass, bone mineral mass, visceral fat, phase angle and edema index) were evaluated. Height (with SECA 206), body weight (with TANITA MC-780), neck and waist circumferences (with SECA 201) of participants were recorded. Heights were measured while standing upright and without shoes, feet were placed side by side, head was placed on the Frankfort Horizontal Plane, occipital region toucing the stadiometer. The body mass index (BMI) of the participants was calculated by dividing the body weight (kg) by the square the height (metres) and the evaluation was made according to the classification of the World Health Organization.

    Measured: From enrollment to the end of treatment at 6 weeks

  3. Mental Health

    The Warwick-Edinburgh Mental Well-Being Scale developed by Tennant et al. (2007) and validated in Turkish by Keldal (2015), was used to evaluate the mental health status of individuals. The WEMWBS total score is calculated by adding the scores assigned to each of the 14 items (1=never to 5=always). The minimum score that can be obtained is 14, whereas the maximum score obtained is 70. Higher scores are associated with higher mental well-being.

    Measured: From enrollment to the end of treatment at 6 weeks

  4. Immunity and Systemic-Inflammation

    Evaluation of immunity and systemic inflammation was performed using complete blood cell count and the SII, which is an important marker in reflecting inflammation and immune response. Although platelet-lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR) are associated with disease activity, however, it has been suggested that SII, which is calculated by using platelet, neutrophil, and lymphocyte counts together, is a much more important marker in showing inflammation and immune response as compared to PLR and NLR values alone. Furthermore, SII is associated with various diseases such as cancer and cardiovascular disease. SII value is calculated with a formula (SII=P×N/L, P; platelet, N; neutrophil, L; lymphocyte) and high scores are associated with adverse health outcomes.

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (3)
  1. Physical Activity

    Participants were asked to maintain their usual physical activities. The physical activity levels of the participants were evaluated with the Short Physical Activity Assessment Tool. The tool consisted of two questions focusing on 20 minutes of vigorous physical activity (running, weightlifting, cycling, etc.) and 30 minutes of moderate physical activity (mowing grass, lifting light loads, etc.). A maximum score of 8 and a minimum score of 0 could be obtained by this tool. A total score of 0-3 was considered insufficiently active, and a score of ≥4 was considered sufficiently active.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. Biochemical Parameters

    Blood analysis for the following parameters (fasting blood glucose, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), total cholesterol, triglyceride, alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), urea, uric acid, creatinine, bilirubin, C-reactive protein (CRP), iron, iron binding capacity) was performed and the hemogram obtained at the beginning and end (pre and post intervention) of the study. The systemic immune-inflammation index (SII) was calculated from the hemogram findings.

    Measured: From enrollment to the end of treatment at 6 weeks

  3. Dietary Patterns

    Participants were asked to maintain their usual eating habits. They were asked to record 24-hour food consumption for three non-consecutive days, one of which was required to be a weekend. This food record was taken twice; once at the beginning (prior to kefir intervention) and the other at the end (post kefir intervention) of the study. The records were collected from the participants retrospectively. The average daily energy and nutrient intakes of the individuals were determined by taking the average of the food consumption consumption values of the three days. The dietary quality of the participants was evaluated with the HEI-2015, which was calculated using data from food consumption records. If the HEI-2015 score of the participants was ≤50 points, the diet quality was evaluated as "poor diet quality", 51-80 points as "diet quality to be improved", and \>80 points as "good diet quality".

    Measured: From enrollment to the end of treatment at 6 weeks

Timeline

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

  1. First posted25 Sep 2024
  2. Study start1 Feb 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06612164
Sponsor's protocol ID
720
Acronym
KefirCons
Status last verified
Sep 2024
First submitted
23 Sep 2024
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bakirhan H, Ozyurek Arpa F, Pehlivan M, Kalkan I. Effects of Kefir Consumption on Gastrointestinal Health, Biochemical Parameters, Sleep, and Mental Well-Being in Healthy Young Adults: a Randomized Controlled Trial. J Nutr. 2026 Jan;156(1):101247. doi: 10.1016/j.tjnut.2025.11.016. Epub 2025 Nov 26.

    PubMed 41314291

Questions about this trial

What is this clinical trial studying?

A study testing kefir in people with Effect of Kefir on Healthy Adults, run by Medipol University at 1 site in Turkey (Türkiye).

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 3 inclusion and 7 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 25 Sep 2024. 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 Turkey (Türkiye). 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. 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?

Evaluation of Gastrointestinal Health (time frame: From enrollment to the end of treatment at 6 weeks). 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 NCT06612164, which also lists 1 linked publication.

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 25 Sep 2024.

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KefirCons Clinical Trial NCT06612164 | AzTrials