NCT07840274

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

kefirmedical nutriton theraphyWomen with obesityGastrointestinal symptomsPsychological well-beingProbiotic

Outcome Measures

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.

    Baseline and week 12

Secondary Outcomes (13)

  • Change in body mass index (kg/m²)

    Baseline and week 12

  • Change in body fat percentage

    Baseline and week 12

  • Change in fat mass (kg)

    Baseline and week 12

  • Change in muscle mass (kg)

    Baseline and week 12

  • Change in visceral fat level

    Baseline and week 12

  • +8 more secondary outcomes

Study Arms (2)

Medical Nutrition Therapy + Kefir

EXPERIMENTAL

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

Dietary Supplement: Plain KefirBehavioral: Individualized Medical Nutrition Therapy

Medical Nutrition Therapy

ACTIVE COMPARATOR

Participants received individualized medical nutrition therapy alone for 12 weeks.

Behavioral: Individualized Medical Nutrition Therapy

Interventions

Plain KefirDIETARY_SUPPLEMENT

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

Medical Nutrition Therapy + Kefir

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

Medical Nutrition TherapyMedical Nutrition Therapy + Kefir

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Living Center, Karabük

Karabük, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityOverweightPsychological Well-Being

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
This was an open-label study because participants and investigators were aware of the assigned intervention. No masking was implemented.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Prof Dr

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

June 1, 2024

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

September 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations