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OpenTrials
Completed

NCT Number: NCT07840274

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.

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Key information

Conditions

Obesity & Overweight Behavior Body Composition Body Weight Gut Microbiota Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Living Center, Karabük

Karabük, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female 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.

Provision of written informed consent.

Exclusion criteria

Pregnancy or lactation. Current use of antibiotics, probiotic or prebiotic supplements during the study period or within the specified washout period (if applicable in your protocol).

Presence of severe gastrointestinal, renal, hepatic, endocrine, or other serious chronic diseases that could affect study outcomes.

Known allergy or intolerance to kefir or dairy products. Inability to comply with the intervention or follow-up procedures.

Treatment and study plan

Plain Kefir

Dietary Supplement

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

Individualized Medical Nutrition Therapy

Behavioral

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

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and week 12

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

  2. Change in body fat percentage

    Time frame: Baseline and week 12

    Body fat percentage was assessed using bioelectrical impedance analysis.

  3. Change in fat mass (kg)

    Time frame: Baseline and week 12

    Fat mass was assessed using bioelectrical impedance analysis.

  4. Change in muscle mass (kg)

    Time frame: Baseline and week 12

    Muscle mass was assessed using bioelectrical impedance analysis.

  5. Change in visceral fat level

    Time frame: Baseline and week 12

    Visceral fat level was assessed using bioelectrical impedance analysis.

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

    Time frame: Baseline and week 12

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

  7. Change in fasting insulin (µIU/mL)

    Time frame: Baseline and week 12

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

  8. Change in total cholesterol (mg/dL)

    Time frame: Baseline and week 12

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

  9. Change in LDL cholesterol (mg/dL)

    Time frame: Baseline and week 12

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

  10. Change in triglycerides (mg/dL)

    Time frame: Baseline and week 12

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

  11. Change in gastrointestinal symptoms (GSRS total score)

    Time frame: Baseline and week 12

    Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores indicate more severe gastrointestinal symptoms.

  12. Change in Bristol Stool Scale score

    Time frame: Baseline and week 12

    Stool consistency was assessed using the Bristol Stool Scale.

  13. Change in Psychological Well-Being Scale total score

    Time frame: Baseline and week 12

    Psychological well-being was assessed using the Psychological Well-Being Scale.

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Sponsors and collaborators

Lead sponsor

Pınar Göbel

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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