ClinicalTrials.gg
CompletedNCT07840274Updated Oct 16, 2026

Effects of Daily Kefir Consumption During Medical Nutrition Therapy on Body Composition and Psychological Well-Being in Women With Obesity

An interventional study of Plain Kefir and Individualized Medical Nutrition Therapy in Obesity & Overweight, Gut Microbiota and Body Composition, sponsored by Pınar Göbel. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Pınar Göbel · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jun 2024, registered Sep 2026).
Updated Oct 16, 2026Eligibility revisedNewly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 353 studies in Obesity with a site in Turkey — 73 open to participants now, 91 under way, 16 of them phase 3. Obesity · Turkey.

Enrollment
92nd of 192
68 · median 64
Started
2024
with 37 others
No phase
161 of 353
29 open now
Registered
335th of 353
by date

Among the 353 studies in Obesity with a site in Turkey, this one is the 92nd largest by enrollment of the 192 interventional ones that give a count, is one of 38 that started in 2024, is one of 161 with no phase, and was the 335th registered.

Obesity

11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.

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Open to participants now

73 of the 353 studies in Obesity with a site in Turkey are open now. Recruiting first, the newest first:

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A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study summary

This randomized controlled study evaluated the effects of daily kefir consumption as an adjunct to medical nutrition therapy on body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being in women with obesity. Participants were randomly assigned to receive either 200 mL of plain kefir daily together with individualized medical nutrition therapy or individualized medical nutrition therapy alone for 12 weeks. Assessments were performed at baseline, week 6, and week 12. The primary outcome was change in body weight. Secondary outcomes included changes in body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being.

Read the detailed description

This study was designed as a randomized, parallel-group, controlled clinical trial to evaluate the effects of daily kefir consumption as an adjunct to individualized medical nutrition therapy in women with obesity. Participants were randomly assigned to one of two intervention groups: (1) individualized medical nutrition therapy plus 200 mL of plain kefir consumed daily, or (2) individualized medical nutrition therapy alone. Both interventions were continued for 12 weeks.

Participants were assessed at baseline, week 6, and week 12. The primary outcome was change in body weight. Secondary outcomes included changes in body mass index, body fat mass, muscle mass, biochemical parameters (fasting blood glucose, lipid profile, liver function tests, and related metabolic markers), gastrointestinal symptoms, bowel habits, stool characteristics, and psychological well-being.

The study aimed to investigate whether the addition of daily kefir consumption to individualized medical nutrition therapy could provide additional benefits beyond diet therapy alone for improving obesity-related health outcomes in women.

03

Conditions studied

  • Obesity & Overweight
  • Gut Microbiota
  • Body Composition

Keywords

  • kefir
  • medical nutriton theraphy
  • Women with obesity
  • Gastrointestinal symptoms
  • Psychological well-being
  • Probiotic
04

Who can participate

The criteria were revised on the registry on Oct 16, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

nclusion Criteria:

  • Female participants aged 25-55 years.
  • (BMI) ≥30 kg/m².
  • Willingness to participate in the study and comply with the intervention protocol.
  • Provision of written .

Exclusion Criteria:

  • Pregnancy or lactation.
  • Current use of antibiotics, probiotic supplements, or prebiotic supplements during the study period.
  • Presence of chronic diseases.
  • Known allergy or intolerance to kefir or dairy products.
  • Inability to comply with the intervention or follow-up procedures.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Medical Nutrition Therapy + Kefir

    Participants received individualized medical nutrition therapy together with 200 mL/day of plain kefir for 12 weeks.

    Dietary Supplement: Plain Kefir · Behavioral: Individualized Medical Nutrition Therapy

  • Active comparator
    Medical Nutrition Therapy

    Participants received individualized medical nutrition therapy alone for 12 weeks.

    Behavioral: Individualized Medical Nutrition Therapy

Interventions

  • Dietary supplementPlain Kefir

    Participants consumed 200 mL of plain kefir daily for 12 weeks in addition to individualized medical nutrition therapy.

  • BehavioralIndividualized Medical Nutrition Therapy

    Participants received individualized medical nutrition therapy delivered by a registered dietitian throughout the 12-week intervention period.

06

What researchers measure

Primary outcomes

  1. Change in body weight (kg) from baseline to week 12

    Body weight was measured in kilograms using a calibrated digital scale. The primary outcome was the change in body weight from baseline to week 12.

    Time frame: Baseline and week 12

Secondary outcomes

  1. Change in body mass index (kg/m²)

    Body mass index was calculated as weight in kilograms divided by height in meters squared. The change from baseline to week 12 was evaluated.

    Time frame: Baseline and week 12

  2. Change in body fat percentage

    Body fat percentage was assessed using bioelectrical impedance analysis.

    Time frame: Baseline and week 12

  3. Change in fat mass (kg)

    Fat mass was assessed using bioelectrical impedance analysis.

    Time frame: Baseline and week 12

  4. Change in muscle mass (kg)

    Muscle mass was assessed using bioelectrical impedance analysis.

    Time frame: Baseline and week 12

  5. Change in visceral fat level

    Visceral fat level was assessed using bioelectrical impedance analysis.

    Time frame: Baseline and week 12

  6. Change in fasting blood glucose (mg/dL)

    Fasting blood glucose was measured in mg/dL. The change from baseline to week 12 was evaluated.

    Time frame: Baseline and week 12

  7. Change in fasting insulin (µIU/mL)

    Fasting insulin concentration was measured in µIU/mL. The change from baseline to week 12 was evaluated.

    Time frame: Baseline and week 12

  8. Change in total cholesterol (mg/dL)

    Total cholesterol concentration was measured in mg/dL. The change from baseline to week 12 was evaluated.

    Time frame: Baseline and week 12

  9. Change in LDL cholesterol (mg/dL)

    Low-density lipoprotein (LDL) cholesterol concentration was measured in mg/dL. The change from baseline to week 12 was evaluated.

    Time frame: Baseline and week 12

  10. Change in triglycerides (mg/dL)

    High-density lipoprotein (HDL) cholesterol concentration was measured in mg/dL. The change from baseline to week 12 was evaluated.

    Time frame: Baseline and week 12

  11. Change in gastrointestinal symptoms (GSRS total score)

    Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item questionnaire evaluating abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is scored from 1 (no discomfort) to 7 (very severe discomfort), resulting in a total score ranging from 15 to 105. Higher scores indicate greater severity of gastrointestinal symptoms and therefore a worse outcome. Changes in total scores from baseline to week 12 were evaluated.

    Time frame: Baseline and week 12

  12. Change in Bristol Stool Scale score

    Stool consistency was assessed using the Bristol Stool Form Scale (BSFS), which classifies stool into seven types, ranging from Type 1 (separate hard lumps) to Type 7 (entirely liquid stool). Scores range from 1 to 7. Lower scores indicate harder stools, while higher scores indicate softer or more liquid stools. Types 3 and 4 are generally considered indicative of normal stool consistency. Therefore, higher scores do not necessarily indicate a better or worse outcome. Changes in stool consistency from baseline to week 12 were evaluated.

    Time frame: Baseline and week 12

  13. Change in Psychological Well-Being Scale total score

    Psychological well-being was assessed using the Psychological Well-Being Scale (Flourishing Scale), developed by Diener et al. and adapted into Turkish by Telef. The scale consists of eight items rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 8 to 56, with higher scores indicating greater psychological well-being and therefore a better outcome. Changes in total scores from baseline to week 12 were evaluated.

    Time frame: Baseline and week 12

07

Study locations

1 site
  • Healthy Living Center, Karabük
    Karabük, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Sep 2024, 3 months.

Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.

Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2026
First posted
Sep 25, 2026
StartActual
Jun 1, 2024
Primary completionActual
Sep 30, 2024
CompletionActual
Dec 31, 2024
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 exclusion criterion removed; 3 criteria edited, 7 added
What changed in the criteria
  • Addednclusion Criteria:
  • AddedFemale participants aged 25-55 years.
  • AddedBody mass index (BMI) ≥30 kg/m².
  • EditedFemale participants aged 18 years or older. Diagnosis of obesity (BMI ≥30 kg/m²). Willingness to participate in the study and comply with the intervention protocol.
  • AddedExclusion Criteria:
  • AddedPregnancy or lactation.
  • EditedPregnancy or lactation. Current use of antibiotics, probiotic supplements, or prebiotic supplements during the study period or within the specified washout period (if applicable in your protocol).
  • AddedPresence of chronic diseases.
  • AddedKnown allergy or intolerance to kefir or dairy products.
  • EditedKnown allergy or intolerance to kefir or dairy products. Inability to comply with the intervention or follow-up procedures.
Exclusion criteria
  • RemovedPresence of severe gastrointestinal, renal, hepatic, endocrine, or other serious chronic diseases that could affect study outcomes.
Oct 16, 2026
Secondary outcomes
3 description edited
What changed in the outcomes
  • DescriptionChange in Bristol Stool Scale score: how it is measured was reworded
  • DescriptionChange in Psychological Well-Being Scale total score: how it is measured was reworded
  • DescriptionChange in gastrointestinal symptoms (GSRS total score): how it is measured was reworded
Oct 16, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Oct 16, 2026
    Eligibility 1 exclusion criterion removed; 3 criteria edited, 7 added
    What changed in the criteria
    • Addednclusion Criteria:
    • AddedFemale participants aged 25-55 years.
    • AddedBody mass index (BMI) ≥30 kg/m².
    • EditedFemale participants aged 18 years or older. Diagnosis of obesity (BMI ≥30 kg/m²). Willingness to participate in the study and comply with the intervention protocol.
    • AddedExclusion Criteria:
    • AddedPregnancy or lactation.
    • EditedPregnancy or lactation. Current use of antibiotics, probiotic supplements, or prebiotic supplements during the study period or within the specified washout period (if applicable in your protocol).
    • AddedPresence of chronic diseases.
    • AddedKnown allergy or intolerance to kefir or dairy products.
    • EditedKnown allergy or intolerance to kefir or dairy products. Inability to comply with the intervention or follow-up procedures.
    Exclusion criteria
    • RemovedPresence of severe gastrointestinal, renal, hepatic, endocrine, or other serious chronic diseases that could affect study outcomes.
    Secondary outcomes 3 description edited
    What changed in the outcomes
    • DescriptionChange in Bristol Stool Scale score: how it is measured was reworded
    • DescriptionChange in Psychological Well-Being Scale total score: how it is measured was reworded
    • DescriptionChange in gastrointestinal symptoms (GSRS total score): how it is measured was reworded
    + 1 other change: identifiers
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840274
Lead sponsor
Pınar Göbel
Responsible party
Pınar Göbel (Assoc Prof Dr, Saglik Bilimleri Universitesi) — Sponsor-investigator
First posted
Sep 25, 2026
Start date
Jun 1, 2024
Primary completion
Sep 30, 2024
Completion
Dec 31, 2024
Last update
Oct 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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