Obesity and OverweightKOMBIOMENCT06759324
Kombucha in Overweight and Obese: Live Vs. Pasteurized Effects on Microbiota, Metabolism, and Liver Function
A study testing Live kombucha (non filtered/ non pasteurized) and Pasteurized kombucha (non filtered) in people with Obesity and Overweight, run by Associação Centro de Apoio Tecnológico Agro Alimentar at 2 sites in Portugal.
Trial summary
Kombucha, a fermented beverage made from Camellia sinensis tea (black, oolong, or green) with sugar and a symbiotic culture of bacteria and yeast (SCOBY), has gained global attention for its potential health benefits. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Live kombucha (non filtered/ non pasteurized) and Pasteurized kombucha (non filtered)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesPortugal
- Study dates
- 11 Oct 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with a Body Mass Index (BMI) between 25 kg/m² and 34.9 kg/m², of both biological sexes, aged between 18 and 60 years, available to comply with the study protocol (described in this document) and sign informed consent.
Who cannot join
- Volunteers will be excluded from the study if they present one or more of the following conditions:
- Subjects with sensitivity to kombucha;
- Consumption of kombucha, kefir, kimchi, cheese, raw vinegar, sauerkraut, kvass, and other fermented products during the study and in the 3 weeks before the study.
- Use of antibiotics in the 6 months prior to the start of the study;
- Use of pro/prebiotics or fibers as dietary supplements or any food/molecule that modifies intestinal transit time 6 weeks before recruitment; use of laxatives 6 weeks before recruitment;
- Specific dietary regimen (e.g., vegan); specific dietary treatment (e.g., high protein);
Show all 13Show fewer
- Excessive consumption of substances and alcohol; smokers;
- Diagnosis of gastrointestinal disorders, hormonal or thyroid diseases, autoimmune diseases, and/or chronic use of corticosteroids; psychiatric disease; Type 1 or 2 diabetes;
- Use of proton pump inhibitors; antidiabetic drugs or insulin and statins;
- Subjects with insulin sensitivity;
- Pregnant or lactating women;
- Subjects with tooth sensitivity
- Participation in another clinical trial in the last 3 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Filomena Pereira, Nutritionist contact
Portugal2 sites, 2 recruiting
- Recruiting
Centro de Apoio Tecnológico Agro Alimentar (CATAA)
Castelo Branco, Castelo Branco District, 6000-459
Inês Brandão, PhD, +351926777221, inesbrandao@cataa.pt
Filomena Pereira, M.Sc. (Nutritionist), +351912069989, nutricao@cataa.pt
- Recruiting
Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the Affidea clinical analysis center)
Covilha, 6200-077
Filomena Pereira, MSc (Nutritionist), +351912069989, nutricao@cataa.pt
About this study
Official title: Randomized Controlled Pilot Clinical Study Including Kombucha in the Diet of Individuals with Overweight and Class 1 Obesity: Comparative Assessment Between Live and Pasteurized Kombucha and Its Effects on Gut Microbiota, Metabolic Parameters, and Liver Function [FUSILLI Project -H2020]
Kombucha, a fermented beverage made from Camellia sinensis tea (black, oolong, or green) with sugar and a symbiotic culture of bacteria and yeast (SCOBY), has gained global attention for its potential health benefits. Factors like the type and amount of sugar substrate, fermentation time, and temperature significantly influence its organic compounds, total phenolics, vitamin content, and alcohol levels.
In a previous study, kombucha's impact on glucose tolerance, insulin sensitivity, body composition, and liver function was tested in male prediabetic mice with diet-induced obesity. Daily supplementation (200 µL per mouse) improved glucose tolerance after nine days (equivalent to one year in humans) and reduced liver steatosis, despite no changes in body composition.
Although kombucha has been associated with antioxidant, antimicrobial, probiotic, antidiabetic, and anticancer activities, strong scientific evidence in humans remains limited. Further clinical studies are needed to substantiate kombucha's health benefits in humans.
Read the detailed description
The objectives of this clinical study aim to explore the effects of kombucha on the health of individuals with overweight and class 1 obesity, while also determining whether the kombucha microbiota plays a role in the observed effects. Specifically, by investigating metabolic parameters such as glucose and insulin levels and lipid profile, as well as the composition and diversity of the gut microbiota and liver function, the study will contribute to a deeper understanding of the potential benefits and mechanisms of action of kombucha consumption in humans. The study aims to recruit at least 30 individuals with overweight and class 1 obesity, aged between 18 and 60 years, randomly distributed into 3 arms (each arm should have about 10 participants). The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks, the second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks. The control group receives 33 cl of sparkling water for 4 weeks.
- Conditions
- Obesity and Overweight
- Being tested
- Live kombucha (non filtered/ non pasteurized), Pasteurized kombucha (non filtered), Control (sparkling water)
- Keywords
- kombucha, gut microbiota, obesity, liver function, fermented beverages, Randomized Controlled Trial, overweight, fermented tea, SCOBY, live vs pasteurized kombucha, Small Intestinal Bacterial Overgrowth (SIBO), Bristol Stool Form Scale, Likert Scale Analysis, Nutritional Interventions, Inflammatory Biomarkers, metabolic parameters
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live kombucha (non filtered/ non pasteurized)Dietary supplement
Participants receive a daily amount of 33 cl of live kombucha (non-pasteurized/ non-filtered) for 4 weeks (28 days).
Pasteurized kombucha (non filtered)Dietary supplement
Participants receive a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (28 days).
Control (sparkling water)Other
Participants receive a daily amount of 33 cl of sparkling water for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Kombucha (live drink) | Experimental | The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks (dietary supplement). Receives: Dietary Supplement: Live kombucha (non filtered/ non pasteurized) |
| Intervention: Pasteurized kombucha | Experimental | The second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (dietary supplement). Receives: Dietary Supplement: Pasteurized kombucha (non filtered) |
| Sparkling water | Active comparator | The third arm receives 33 cl of sparkling water for 4 weeks (control). Receives: Other: Control (sparkling water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut microbiota composition and diversity (fecal samples)
Analyze the changes in the relative abundance of the microbial species present, including taxonomic identification and diversity analysis, from baseline to the end of intervention, by next-generation sequencing (NGS).
Measured: 4 weeks
Change in fasting glucose levels
Fasting glucose (mg/dl), from baseline to the end of intervention. Reduction is a better outcome.
Measured: 4 weeks
Change in fasting insulin levels
Fasting insulin (μUI/mL), from baseline to the end of intervention. Reduction is a better outcome.
Measured: 4 weeks
Changes in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) values
HOMA-IR values, from baseline to the end of intervention. Calculated from fasting glucose (mmol/L) X fasting insulin (mU/L) / 22.5). Less than 1.0 means insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. Reduction is a better outcome.
Measured: 4 weeks
Changes in Lipid profile
Lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides), in mg/dL, from baseline to the end of intervention.
Measured: 4 weeks
Secondary outcomes (9)
Stool consistency rating by Bristol Stool Scale
The Bristol Stool Chart is a medical tool used to classify human feces into seven distinct categories. This scale is widely regarded as the gold standard for evaluating stool consistency and intestinal transit time in adults. It ranges from type 1 (separate hard lumps), which indicates the slowest transit time and constipation, to type 7 (watery with no solid pieces), representing the fastest transit time. Daily monitoring questionnaire (to evaluate 1 to 7), from baseline to the end of intervention.
Measured: 4 weeks
Variation in SIBO diagnosis (positive/negative) measured by methane and hydrogen levels in breath test
Hyrogen and methane lactulose breath test, in ppm, from baseline to end of intervention. Interpretation criteria: SIBO test is positive if there is an early increase (in the first 90 minutes) equal to or greater than 20 ppm of H2 and/or equal to or greater than 10 ppm of CH4, when compared with the lowest value obtained.
Measured: 4 weeks
Change in liver enzyme levels
Analyze liver enzymes (units: in UI/L) such as alkaline phosphatase, alanine transaminase, aspartate transaminase, gamma-glutamyl transferase, from baseline to end of intervention, to determine potential hepatic effects of Kombucha consumption.
Measured: 4 weeks
Change in levels of oxidative stress biomarker (ratio 8-iso-PGF2α to prostaglandin F2α (PGF2α))
Measure of oxidative stress biomarker (pg/mL ), from baseline to the end of intervention. Normal human plasma reference values: 40-100 pg/mL.
Measured: 4 weeks
Change in gastrointestinal symptoms using a Likert scale
Evaluate gastrointestinal symptoms (e.g., bloating, gas) using a 10-point Likert scale, from baseline to the end of intervention. The daily questionnaire goes from zero (0) which means "no pain" to ten (10) which means "worst pain imaginable".
Measured: 4 weeks
Change in high-sensitive C-reactive protein levels
Levels of h-sensitivity C-reactive protein (hsCRP), a marker of inflammation, in mg/dL, from baseline to the end of intervention. hsCRP levels of less than 0.100, 0.100 to 0.300, and greater than 0.301 mg/dL are associated with lower, moderate, and higher cardiovascular risks, respectively.
Measured: 4 weeks
Change in Total oxidant capacity
Oxidative stress biomarker, pg/mL, measured from baseline to the end of intervention. Normal values range from 40-100.
Measured: 4 weeks
Changes in serum albumin and bilirubin levels
Evaluate hepatobiliary function, albumin (g/dL), Bilirubin (mg/dL)
Measured: 4 weeks
Changes in short chain fatty acids in stool
SCFAs in stool, units µM
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start11 Oct 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study aims to recruit at least 30 individuals with overweight and class 1 obesity, aged between 18 and 60 years, randomly distributed into 3 arms (each arm should have about 10 participants). The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks, the second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks. The control group receives 33 cl of water for 4 weeks. Kombucha samples are prepared for the study by Erfrischerling GmbH \& Co. KG (Germany).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Centro de Apoio Tecnológico Agro Alimentar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inês Brandão, Associação Centro de Apoio Tecnológico Agro Alimentar
- Investigators
- Brandão, PhD, Principal investigator, CATAA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759324
- Sponsor's protocol ID
- FUSILLI: PARECER (02/2024)
- Other IDs
- Grant agreement No. 101000717
- Acronym
- KOMBIOME
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreira GV, Araujo LCC, Murata GM, Matos SL, Carvalho CRO. Kombucha tea improves glucose tolerance and reduces hepatic steatosis in obese mice. Biomed Pharmacother. 2022 Nov;155:113660. doi: 10.1016/j.biopha.2022.113660. Epub 2022 Sep 12.
PubMed 36095960
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Clinical Study Including Kombucha in the Diet of Individuals with Overweight and Class 1 Obesity: Comparative Assessment Between Live and Pasteurized Kombucha and Its Effects on Gut Microbiota, Metabolic Parameters, and Liver Function [FUSILLI Project -H2020]
- ClinicalTrials.gov ID
- NCT06759324
- Acronym / sponsor ID
- KOMBIOME / FUSILLI: PARECER (02/2024)
- Conditions
- Obesity and Overweight
- Keywords
- kombucha, gut microbiota, obesity, liver function, fermented beverages, Randomized Controlled Trial, overweight, fermented tea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Associação Centro de Apoio Tecnológico Agro AlimentarUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kombucha, a fermented beverage made from Camellia sinensis tea (black, oolong, or green) with sugar and a symbiotic culture of bacteria and yeast (SCOBY), has gained global attention for its potential health benefits. Factors like the type and amount of sugar substrate, fermentation time, and temperature significantly influence its organic compounds, total phenolics, vitamin content, and alcohol levels.
In a previous study, kombucha's impact on glucose tolerance, insulin sensitivity, body composition, and liver function was tested in male prediabetic mice with diet-induced obesity. Daily supplementation (200 µL per mouse) improved glucose tolerance after nine days (equivalent to one year in humans) and reduced liver steatosis, despite no changes in body composition.
Although kombucha has been associated with antioxidant, antimicrobial, probiotic, antidiabetic, and anticancer activities, strong scientific evidence in humans remains limited. Further clinical studies are needed to substantiate kombucha's health benefits in humans.
Detailed description
The objectives of this clinical study aim to explore the effects of kombucha on the health of individuals with overweight and class 1 obesity, while also determining whether the kombucha microbiota plays a role in the observed effects. Specifically, by investigating metabolic parameters such as glucose and insulin levels and lipid profile, as well as the composition and diversity of the gut microbiota and liver function, the study will contribute to a deeper understanding of the potential benefits and mechanisms of action of kombucha consumption in humans. The study aims to recruit at least 30 individuals with overweight and class 1 obesity, aged between 18 and 60 years, randomly distributed into 3 arms (each arm should have about 10 participants). The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks, the second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks. The control group receives 33 cl of sparkling water for 4 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study aims to recruit at least 30 individuals with overweight and class 1 obesity, aged between 18 and 60 years, randomly distributed into 3 arms (each arm should have about 10 participants). The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks, the second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks. The control group receives 33 cl of water for 4 weeks. Kombucha samples are prepared for the study by Erfrischerling GmbH \& Co. KG (Germany).
| Arm | Type | Receives |
|---|---|---|
| Intervention: Kombucha (live drink) | Experimental | Dietary Supplement: Live kombucha (non filtered/ non pasteurized)The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks (dietary supplement). |
| Intervention: Pasteurized kombucha | Experimental | Dietary Supplement: Pasteurized kombucha (non filtered)The second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (dietary supplement). |
| Sparkling water | Active comparator | Other: Control (sparkling water)The third arm receives 33 cl of sparkling water for 4 weeks (control). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with a Body Mass Index (BMI) between 25 kg/m² and 34.9 kg/m², of both biological sexes, aged between 18 and 60 years, available to comply with the study protocol (described in this document) and sign informed consent.
Key exclusion criteria (13 listed)
- Volunteers will be excluded from the study if they present one or more of the following conditions:
- Subjects with sensitivity to kombucha;
- Consumption of kombucha, kefir, kimchi, cheese, raw vinegar, sauerkraut, kvass, and other fermented products during the study and in the 3 weeks before the study.
- Use of antibiotics in the 6 months prior to the start of the study;
- Use of pro/prebiotics or fibers as dietary supplements or any food/molecule that modifies intestinal transit time 6 weeks before recruitment; use of laxatives 6 weeks before recruitment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live kombucha (non filtered/ non pasteurized)Participants receive a daily amount of 33 cl of live kombucha (non-pasteurized/ non-filtered) for 4 weeks (28 days). | Dietary supplement | Intervention: Kombucha (live drink) |
| Pasteurized kombucha (non filtered)Participants receive a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (28 days). | Dietary supplement | Intervention: Pasteurized kombucha |
| Control (sparkling water)Participants receive a daily amount of 33 cl of sparkling water for 4 weeks. | Other | Sparkling water |
Primary outcome
Change in Gut microbiota composition and diversity (fecal samples)
Time frame: 4 weeks
Analyze the changes in the relative abundance of the microbial species present, including taxonomic identification and diversity analysis, from baseline to the end of intervention, by next-generation sequencing (NGS).
Change in fasting glucose levels
Time frame: 4 weeks
Fasting glucose (mg/dl), from baseline to the end of intervention. Reduction is a better outcome.
Change in fasting insulin levels
Time frame: 4 weeks
Fasting insulin (μUI/mL), from baseline to the end of intervention. Reduction is a better outcome.
Changes in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) values
Time frame: 4 weeks
HOMA-IR values, from baseline to the end of intervention. Calculated from fasting glucose (mmol/L) X fasting insulin (mU/L) / 22.5). Less than 1.0 means insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. Reduction is a better outcome.
Changes in Lipid profile
Time frame: 4 weeks
Lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides), in mg/dL, from baseline to the end of intervention.
9 secondary outcomes
Stool consistency rating by Bristol Stool Scale
Time frame: 4 weeks
Variation in SIBO diagnosis (positive/negative) measured by methane and hydrogen levels in breath test
Time frame: 4 weeks
Change in liver enzyme levels
Time frame: 4 weeks
Change in levels of oxidative stress biomarker (ratio 8-iso-PGF2α to prostaglandin F2α (PGF2α))
Time frame: 4 weeks
Change in gastrointestinal symptoms using a Likert scale
Time frame: 4 weeks
Change in high-sensitive C-reactive protein levels
Time frame: 4 weeks
Change in Total oxidant capacity
Time frame: 4 weeks
Changes in serum albumin and bilirubin levels
Time frame: 4 weeks
Changes in short chain fatty acids in stool
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 36095960Moreira GV, Araujo LCC, Murata GM, Matos SL, Carvalho CRO. Kombucha tea improves glucose tolerance and reduces hepatic steatosis in obese mice. Biomed Pharmacother. 2022 Nov;155:113660. doi: 10.1016/j.biopha.2022.113660. Epub 2022 Sep 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filomena Pereira, Nutritionist contact
Brandão, PhD principal investigator
CATAA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live kombucha (non filtered/ non pasteurized) and Pasteurized kombucha (non filtered) in people with Obesity and Overweight, run by Associação Centro de Apoio Tecnológico Agro Alimentar at 2 sites in Portugal.
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 1 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inês Brandão, PhD (+351926777221, inesbrandao@cataa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut microbiota composition and diversity (fecal samples) (time frame: 4 weeks). The study lists 5 primary outcomes in all. 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 NCT06759324, which also lists 1 linked publication.
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 6 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.