- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06753422
Kefir, Gut Microbiota, and Athletic Performance in Soccer Players (KEFIR-SPORT)
Effects of Kefir Consumption on Gut Microbiota and Athletic Performance in Professional Female Soccer Players: a Randomized Controlled Trial
This research work is a clinical trial that will assess the impact of kefir consumption on the gut microbiota profile and athletic performance of female soccer players of age 18-29 years. The participants were divided into two groups namely the kefir intervention group and the control group. The primary end points are the modifications in the alpha diversity of the gut microbiome and the beta diversity of the gut microbiome and also the athletic performance outcomes like VO2 max and finishing speed which will be measured using the 30-15 Intermittent Fitness Test. The other outcomes of the study are the changes in the body composition (measured through BIA and skinfold), the changes in the dietary intake and the variations in certain microbial genera such as Akkermansia muciniphila and Faecalibacterium prausnitzii.
The study will be the first to evaluate whether kefir intake can increase the microbial diversity, increase the VO2max and improve the body composition of professional athletes. The anticipated outcomes of this study are enhanced gut microbial diversity, enhanced VO2max and finishing speed, and positive alteration in the body composition parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial aims at evaluating the impact of kefir on the participants' gut microbiota and athletic performance among professional female soccer players of 18-29 years. The present study is intended to reveal the potential of kefir, a fermented milk product that is packed with probiotics , in altering the diversity and profile of gut microbiota, physical performance, and parameters of body composition.
This trial was carried out for a period of four weeks and the subjects were divided into two parallel groups; the kefir group in which the participants consume 200ml of kefir per day and the control group in which the participants continued with their normal diet without kefir supplementation. The subjects were assigned to either of the two groups at the beginning of the study. Since the study involved a dietary intervention, the trial was conducted without blinding the subject and the researcher. Measurements were made at the beginning and at the end of the intervention in order to evaluate the outcomes.
The main goals of the study were to observe the changes in the diversity and the composition of the gut microbiome with the help of 16S rRNA sequencing and to determine the changes in the athletic performance indices including VO2max and finishing speed which was measured by 30-15 Intermittent Fitness Test. Other objectives were to establish the effects of kefir on other body composition measures such as body fat percentage, fat free mass and total body weight , to examine the patterns of dietary intakes and their relationships with the microbiota and performance measures and to examine the changes in certain gut microorganisms including Akkermansia muciniphila and Faecalibacterium prausnitzii which are known to have positive effects on human health and performance.
The alpha diversity of the gut microbiome was measured with the Shannon and Chao1 indices and the beta diversity was calculated with the Bray-Curtis dissimilarity. The taxonomic analysis was done at the phylum, genus and species level in order to identify the changes in the microbial community due to consumption of kefir. The participants' athletic performance was evaluated with IFT Test to explore the changes in VO2max and finishing speed. Changes in the body composition were assessed by Bioelectrical Impedance Analysis (BIA) and skinfold callipers and the dietary intake data were collected through three-day food records, one off day and two training days to examine the macronutrients and micronutrients intake and their relationship with the microbiota and performance.
This trial seeks to fill an important research gap in the current literature on functional foods in sports nutrition with focus on professional female athletes. In this way, the current study seeks to link dietary interventions with the gut microbiota as well as performance parameters in order to provide empirical support for how kefir can improve the gut health and performance of athletes and to facilitate the development of personalised nutrition for athletes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İstanbul, Turkey, 34091
- Fatih Vatan Sports Club
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Professional female soccer player
- Aged between 18 and 35 years
- Regular participation in a structured training program
- No allergy or intolerance to kefir or dairy products
- Willingness to voluntarily participate in the study
- Signed informed consent form
Exclusion criteria:
- History of allergy or intolerance to kefir or dairy products
- Presence of chronic diseases (e.g., diabetes, heart disease, kidney failure)
- Use of antibiotics or probiotic supplements within the last 3 months
- Pregnancy or breastfeeding
- Inability to comply with the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Kefir Consumption Group
Participants in this group will consume 200 ml of kefir daily for 4 weeks. Their diet will remain ad libitum, with no additional dietary restrictions or standardization applied during the intervention period. The primary intervention in our study is the daily consumption of kefir (200 ml/day). No additional drug or medical device was used during the intervention or data collection process. The study focused solely on kefir consumption and its effects on athletic performance and gut microbiota. |
200 ml/day kefir The primary intervention in our study is the daily consumption of kefir (200 ml/day). No additional drug or medical device was used during the intervention or data collection process. The study focused solely on kefir consumption and its effects on athletic performance and gut microbiota.
Other Names:
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No Intervention: Control Group
Participants in this group will not receive any specific intervention.
They will continue their usual diet ad libitum, with no dietary restrictions or standardization applied during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gut Microbiota Composition Change
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Changes in gut microbiota diversity and abundance at genus and phylum levels, assessed through 16S rRNA gene sequencing of stool samples.
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At baseline and after 4 weeks of intervention (Week 5)
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Athletic Performance Improvement
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Improvement in athletic performance as measured by the 30-15 Intermittent Fitness Test, evaluating VO2max and finishing speed.
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At baseline and after 4 weeks of intervention (Week 5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dietary Intake Assessment
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
|
Changes in macronutrient and micronutrient intake, assessed through 3-day food records analyzed using nutritional analysis software (BEBIS).
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At baseline and after 4 weeks of intervention (Week 5)
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Body weight (kg)
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Body weight will be measured using a bioelectrical impedance analysis (BIA) device (Tanita BC 545-N ) to assess participants' total body weight.
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At baseline and after 4 weeks of intervention (Week 5)
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Body Fat Percentage (%)
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Body fat percentage will be measured using a bioelectrical impedance analysis (BIA) device (Tanita BC 545-N ) to assess the proportion of body weight composed of fat tissue.
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At baseline and after 4 weeks of intervention (Week 5)
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Fat mass (kg)
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Fat mass will be measured using a bioelectrical impedance analysis (BIA) device (Tanita BC 545-N ) to quantify the total weight of fat tissue in the body.
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At baseline and after 4 weeks of intervention (Week 5)
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Fat-free mass (kg)
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Fat-free mass will be measured using a bioelectrical impedance analysis (BIA) device (Tanita BC 545-N ) to determine the weight of lean tissue, bones, and fluids, excluding fat mass.
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At baseline and after 4 weeks of intervention (Week 5)
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Height (m)
Time Frame: At baseline and after 4 weeks of intervention (Week 5)
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Height will be measured using a SECA 213 stadiometer with participants standing upright, without shoes, and with their head in the Frankfurt plane.
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At baseline and after 4 weeks of intervention (Week 5)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Duygu Sağlam, Associate Professor, Acibadem University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-KefirStudy
- TDK-2023-91 (Other Grant/Funding Number: Acıbadem University Scientific Research Projects Unit (BAP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data from gut microbiota analysis, including genus and phylum-level diversity and abundance, assessed using 16S rRNA sequencing.
De-identified performance test data, such as VO2max and finishing speed results from the 30-15 Intermittent Fitness Test.
De-identified body composition data, including body fat percentage and lean muscle mass assessed using BIA and caliper measurements.
De-identified dietary intake data collected through 3-day food records, including macronutrient and micronutrient consumption.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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