Obesity & OverweightNCT07840274
Effects of Daily Kefir Consumption During Medical Nutrition Therapy on Body Composition and Psychological Well-Being in Women With Obesity
A study testing Plain Kefir and Individualized Medical Nutrition Therapy in people with Obesity & Overweight and Gut Microbiota, run by Pınar Göbel at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity & Overweight, Gut Microbiota, Body Composition
- What is being tested?
- Plain Kefir and Individualized Medical Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Interventional
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF DAILY KEFIR CONSUMPTION DURING MEDICAL NUTRITION THERAPY ON BODY COMPOSITION AND PSYCHOLOGICAL WELL-BEING IN WOMEN WITH OBESITY
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.
- Conditions
- Obesity & Overweight, Gut Microbiota, Body Composition
- Being tested
- Plain Kefir, Individualized Medical Nutrition Therapy
- Keywords
- kefir, medical nutriton theraphy, Women with obesity, Gastrointestinal symptoms, Psychological well-being, Probiotic
- Medical subject headings
- Obesity, Overweight, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain KefirDietary supplement
Participants consumed 200 mL of plain kefir daily for 12 weeks in addition to individualized medical nutrition therapy.
Individualized Medical Nutrition TherapyBehavioural
Participants received individualized medical nutrition therapy delivered by a registered dietitian throughout the 12-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Medical Nutrition Therapy + Kefir | Experimental | Participants received individualized medical nutrition therapy together with 200 mL/day of plain kefir for 12 weeks. Receives: Dietary Supplement: Plain Kefir; Behavioral: Individualized Medical Nutrition Therapy |
| Medical Nutrition Therapy | Active comparator | Participants received individualized medical nutrition therapy alone for 12 weeks. Receives: Behavioral: Individualized Medical Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 12
Secondary outcomes (13)
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.
Measured: Baseline and week 12
Change in body fat percentage
Body fat percentage was assessed using bioelectrical impedance analysis.
Measured: Baseline and week 12
Change in fat mass (kg)
Fat mass was assessed using bioelectrical impedance analysis.
Measured: Baseline and week 12
Change in muscle mass (kg)
Muscle mass was assessed using bioelectrical impedance analysis.
Measured: Baseline and week 12
Change in visceral fat level
Visceral fat level was assessed using bioelectrical impedance analysis.
Measured: Baseline and week 12
Change in fasting blood glucose (mg/dL)
Fasting blood glucose was measured in mg/dL. The change from baseline to week 12 was evaluated.
Measured: Baseline and week 12
Change in fasting insulin (µIU/mL)
Fasting insulin concentration was measured in µIU/mL. The change from baseline to week 12 was evaluated.
Measured: Baseline and week 12
Change in total cholesterol (mg/dL)
Total cholesterol concentration was measured in mg/dL. The change from baseline to week 12 was evaluated.
Measured: Baseline and week 12
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.
Measured: Baseline and week 12
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.
Measured: Baseline and week 12
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.
Measured: Baseline and week 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.
Measured: Baseline and week 12
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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jun 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: individualized medical nutrition therapy plus daily kefir consumption or individualized medical nutrition therapy alone. Both interventions were continued for 12 weeks, and outcome measures were assessed at baseline, week 6, and week 12.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pınar Göbel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pınar Göbel, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840274
- Sponsor's protocol ID
- 2023/1364
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No