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Fermented FoodNCT07846072

The Effect of Probiotic Foods on Depression

A study testing Individualized diet excluding fermented foods, Lower-frequency fermented-food dietary intervention and Higher-frequency fermented-food dietary intervention in people with Fermented Food and Depression, run by Nadide Gizem Tarakci Filiz at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This exploratory study examined whether different frequencies of consuming three fermented foods commonly eaten in Türkiye-kefir, tarhana, and mixed pickles-were associated with short-term changes in body measurements and psychological well-being in adults. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Fermented Food, Depression
What is being tested?
Individualized diet excluding fermented foods, Lower-frequency fermented-food dietary intervention and Higher-frequency fermented-food dietary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2020to 15 May 2020
Phase
Interventional
Are there results?
None posted in the registry

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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-55 years
  • Residence in Istanbul, Türkiye
  • BMI 18.0-24.9 kg/m²
  • No regular physical exercise

Who cannot join

  • Chronic medical condition
  • Regular medication use
  • Antidepressant use
  • Probiotic supplement use
  • Psychotherapy
  • Pregnancy
  • Breastfeeding
  • Psychological symptom scores were not used as exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Fatih, 34083

Other trials in Turkey (Türkiye)

About this study

This exploratory study examined whether different frequencies of consuming three fermented foods commonly eaten in Türkiye-kefir, tarhana, and mixed pickles-were associated with short-term changes in body measurements and psychological well-being in adults.

Thirty adults aged 18 to 55 years were randomly assigned to one of three groups for four weeks. The control group followed an individualized dietary plan that excluded fermented foods. The lower-frequency group followed a similar dietary plan and consumed kefir, tarhana, and mixed pickles once per week. The higher-frequency group consumed kefir daily, tarhana four times per week, and mixed pickles three times per week.

Body weight, body mass index, waist circumference, mid-upper arm circumference, estimated body fat measures, depressive symptoms, and general psychological distress were assessed at the beginning and end of the four-week intervention. The study was designed as an exploratory dietary intervention and did not have a prespecified primary outcome.

Read the detailed description

This was an exploratory, three-arm, parallel-group randomized dietary intervention conducted in adults living in Istanbul, Türkiye. The study evaluated two different frequencies of incorporating kefir, tarhana, and mixed pickles into individualized dietary plans over a four-week period.

Thirty participants were randomly allocated in a 1:1:1 ratio to a control group, a lower-frequency fermented-food group, or a higher-frequency fermented-food group. All participants received individualized dietary plans based on estimated daily energy and nutrient requirements. The control-group plan excluded fermented foods. In the intervention groups, the study foods were added to the individualized dietary plans rather than replacing other prescribed food servings.

Participants in the lower-frequency group were instructed to consume one serving each of kefir, tarhana, and mixed pickles once per week. Participants in the higher-frequency group were instructed to consume kefir daily, tarhana soup four times per week, and mixed pickles three times per week. One serving was defined as 200 mL of kefir, one serving of tarhana soup prepared with 20 g of powdered tarhana, and 100 g of mixed pickles. The intervention schedules were intended to create a pragmatic contrast between occasional and more frequent fermented-food consumption rather than microbiologically standardized doses.

Anthropometric assessments included body weight, body mass index, waist circumference, mid-upper arm circumference, estimated body fat percentage, and estimated body fat mass. Psychological outcomes included depressive symptom severity assessed using the Beck Depression Inventory and general psychological distress assessed using the General Health Questionnaire-28. Assessments were performed at baseline and after the four-week intervention.

The study was exploratory and did not have a prespecified primary outcome. All anthropometric and psychological outcomes were analyzed as exploratory study outcomes.

Being tested
Individualized diet excluding fermented foods, Lower-frequency fermented-food dietary intervention, Higher-frequency fermented-food dietary intervention
Keywords
Fermented foods, Kefir, Tarhana, Pickles, Dietary intervention, Body weight, Psychological distress, Depressive symptoms, Randomized controlled trial, Adults
Medical subject headings
Depression, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized diet excluding fermented foodsOther

    Participants followed an individualized dietary plan based on estimated daily energy and nutrient requirements for four weeks. Fermented foods were excluded from the dietary plan, and participants were instructed not to consume additional fermented foods or probiotic supplements during the intervention.

  • Lower-frequency fermented-food dietary interventionOther

    Participants followed an individualized dietary plan for four weeks with the addition of kefir, tarhana soup, and mixed pickles. Participants consumed one 200-mL serving of kefir once per week, one serving of tarhana soup once per week, and one 100-g serving of mixed pickles once per week. One serving of tarhana soup was prepared with 20 g of powdered tarhana, 200 mL of water, 5 g of olive oil, and 5 g of tomato paste.

  • Higher-frequency fermented-food dietary interventionOther

    Participants followed an individualized dietary plan for four weeks with the addition of kefir, tarhana soup, and mixed pickles. Participants consumed one 200-mL serving of kefir daily, one serving of tarhana soup four times per week, and one 100-g serving of mixed pickles three times per week. One serving of tarhana soup was prepared with 20 g of powdered tarhana, 200 mL of water, 5 g of olive oil, and 5 g of tomato paste.

Study groups in NCT07846072
Study groupRoleWhat they receive
Control DietActive comparatorParticipants received an individualized dietary plan based on estimated daily energy and nutrient requirements. The dietary plan excluded fermented foods, and participants were instructed not to consume additional fermented foods or probiotic supplements during the four-week intervention.
Receives: Other: Individualized diet excluding fermented foods
Lower-Frequency Fermented-Food DietExperimentalParticipants received an individualized dietary plan based on estimated daily energy and nutrient requirements. In addition to the base dietary plan, participants were instructed to consume one serving each of kefir, tarhana soup, and mixed pickles once per week for four weeks.
Receives: Other: Lower-frequency fermented-food dietary intervention
Higher-Frequency Fermented-Food DietExperimentalParticipants received an individualized dietary plan based on estimated daily energy and nutrient requirements. In addition to the base dietary plan, participants were instructed to consume kefir daily, tarhana soup four times per week, and mixed pickles three times per week for four weeks.
Receives: Other: Higher-frequency fermented-food dietary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressive symptom severity assessed by the Beck Depression Inventory (BDI)

    Depressive symptom severity was assessed using the 21-item Beck Depression Inventory (BDI). Each item is scored from 0 to 3, yielding a total score from 0 to 63. Higher total scores indicate greater depressive symptom severity. The BDI was administered at baseline and after the four-week dietary intervention.

    The original ethics application focused on depression and general health but did not formally classify outcomes as primary or secondary. For retrospective registration, depressive symptom severity assessed by the BDI is listed as the primary outcome because depression was the principal focus reflected in the original study title.

    Measured: Baseline and Week 4

Secondary outcomes (7)
  1. Body weight (kg)

    Body weight was measured in kilograms using an Arzum AR550 Sottile digital glass bathroom scale. Measurements were obtained by the same assessor with participants wearing light clothing and no shoes.

    Measured: Baseline and Week 4

  2. Body mass index (BMI) (kg/m²)

    Body mass index was calculated as body weight in kilograms divided by height in meters squared (kg/m²). Body weight and height were assessed by the same assessor, with participants wearing light clothing and no shoes.

    Measured: Baseline and Week 4

  3. General psychological distress assessed by the General Health Questionnaire-28 (GHQ-28)

    General psychological distress was assessed using the 28-item General Health Questionnaire (GHQ-28). Items were scored using the binary GHQ method (0-0-1-1), yielding a total score from 0 to 28. Higher total scores indicate greater psychological distress. The GHQ-28 was administered at baseline and after the four-week dietary intervention.

    Measured: Baseline and Week 4

  4. Waist circumference (cm)

    Waist circumference was measured in centimeters at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, following World Health Organization guidance. Measurements were obtained using a non-stretch tape measure.

    Measured: Baseline and Week 4

  5. Mid-upper arm circumference (cm)

    Mid-upper arm circumference was measured in centimeters using an assessment procedure based on Frisancho. Measurements were obtained by the same assessor.

    Measured: Baseline and Week 4

  6. Estimated body fat percentage (%)

    Body fat percentage was estimated from BMI using sex-specific equations. For men, estimated body fat percentage = 1.281 × BMI - 10.13. For women, estimated body fat percentage = 1.480 × BMI - 7.00. Results were expressed as a percentage (%).

    Measured: Baseline and Week 4

  7. Estimated body fat mass (kg)

    Body fat mass was estimated using sex-specific BMI- and height-based equations. For men, estimated body fat mass = [0.715 × BMI - 12.1] × height². For women, estimated body fat mass = [0.713 × BMI - 9.74] × height², with height expressed in meters. Results were expressed in kilograms (kg).

    Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start15 Mar 2020
  3. Primary completion15 May 2020
  4. Study completion15 May 2020

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: a control diet excluding fermented foods, a lower-frequency fermented-food intervention, or a higher-frequency fermented-food intervention. Participants remained in their assigned group throughout the four-week intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846072
Sponsor's protocol ID
10840098-604.01.01-12079
Status last verified
Sep 2026
First submitted
22 Sep 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the study may be made available to qualified researchers upon reasonable request to the corresponding author, subject to review of the proposed use and applicable ethical and data-protection requirements.

Publications

  • Saadati S, Naseri K, Asbaghi O, Yousefi M, Golalipour E, de Courten B. Beneficial effects of the probiotics and synbiotics supplementation on anthropometric indices and body composition in adults: A systematic review and meta-analysis. Obes Rev. 2024 Mar;25(3):e13667. doi: 10.1111/obr.13667. Epub 2023 Nov 29.

    PubMed 38030409
  • Balasubramanian R, Schneider E, Gunnigle E, Cotter PD, Cryan JF. Fermented foods: Harnessing their potential to modulate the microbiota-gut-brain axis for mental health. Neurosci Biobehav Rev. 2024 Mar;158:105562. doi: 10.1016/j.neubiorev.2024.105562. Epub 2024 Jan 24.

    PubMed 38278378
  • Berding K, Vlckova K, Marx W, Schellekens H, Stanton C, Clarke G, Jacka F, Dinan TG, Cryan JF. Diet and the Microbiota-Gut-Brain Axis: Sowing the Seeds of Good Mental Health. Adv Nutr. 2021 Jul 30;12(4):1239-1285. doi: 10.1093/advances/nmaa181.

    PubMed 33693453
  • Aslam H, Green J, Jacka FN, Collier F, Berk M, Pasco J, Dawson SL. Fermented foods, the gut and mental health: a mechanistic overview with implications for depression and anxiety. Nutr Neurosci. 2020 Sep;23(9):659-671. doi: 10.1080/1028415X.2018.1544332. Epub 2018 Nov 11.

    PubMed 30415609
  • Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.

    PubMed 34256014
  • Marco ML, Sanders ME, Ganzle M, Arrieta MC, Cotter PD, De Vuyst L, Hill C, Holzapfel W, Lebeer S, Merenstein D, Reid G, Wolfe BE, Hutkins R. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on fermented foods. Nat Rev Gastroenterol Hepatol. 2021 Mar;18(3):196-208. doi: 10.1038/s41575-020-00390-5. Epub 2021 Jan 4.

    PubMed 33398112

Questions about this trial

What is this clinical trial studying?

A study testing Individualized diet excluding fermented foods, Lower-frequency fermented-food dietary intervention and Higher-frequency fermented-food dietary intervention in people with Fermented Food and Depression, run by Nadide Gizem Tarakci Filiz at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptom severity assessed by the Beck Depression Inventory (BDI) (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07846072, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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