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| ID | Type | Description | Link |
|---|---|---|---|
| Grant agreement No. 101000717 | Other Grant/Funding Number | European Union's Horizon 2020 research and innovation programme |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Kombucha (live drink) | Experimental | The first arm receives a daily amount of 33 cl of kombucha (live drink) for 4 weeks (dietary supplement). |
|
| Intervention: Pasteurized kombucha | Experimental | The second arm receives a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (dietary supplement). |
|
| Sparkling water | Active Comparator | The third arm receives 33 cl of sparkling water for 4 weeks (control). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks |
| Change in fasting glucose levels | Fasting glucose (mg/dl), from baseline to the end of intervention. Reduction is a better outcome. | 4 weeks |
| Change in fasting insulin levels | Fasting insulin (μUI/mL), from baseline to the end of intervention. Reduction is a better outcome. | 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. | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight change | Anthropometric measurement, unit of measure: Kg | 4 weeks |
| BMI change | Body mass index (BMI) is a measure of body fat based on height and weight, unit of measure: Kg/m2 |
Inclusion Criteria:
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.
Exclusion Criteria:
Volunteers will be excluded from the study if they present one or more of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inês Brandão, PhD | Contact | +351926777221 | inesbrandao@cataa.pt | |
| Filomena Pereira, Nutritionist | Contact | filomenapereira@cataa.pt |
| Name | Affiliation | Role |
|---|---|---|
| Brandão, PhD | CATAA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Apoio Tecnológico Agro Alimentar (CATAA) | Recruiting | Castelo Branco | Castelo Branco District | 6000-459 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36095960 | Background | 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. |
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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).
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Partial double blinding (participants will not know if they are consuming live or pasteurized kombucha; the nutritionist will not know which arm the participant belongs to; the technician responsible for microbiota sequencing will receive coded samples without information regarding the intervention/control arm the sample belongs to).
| 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. |
|
| 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. | 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. | 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. | 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". | 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. | 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. | 4 weeks |
| Changes in serum albumin and bilirubin levels | Evaluate hepatobiliary function, albumin (g/dL), Bilirubin (mg/dL) | 4 weeks |
| Changes in short chain fatty acids in stool | SCFAs in stool, units µM | 4 weeks |
| 4 weeks |
| Waist circumference change | Anthropometric measurement, unit of measure: cm | 4 weeks |
| Body fat percentage change | unit of measure: % | 4 weeks |
| Changes in kidney function biomarkers- creatinin, urea and uric acid | units in mg/dL | 4 weeks |
| Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the Affidea clinical analysis center) | Recruiting | Covilha | 6200-077 | Portugal |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D061545 | Carbonated Water |
| ID | Term |
|---|---|
| D008900 | Mineral Waters |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002253 | Carbonated Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D060766 | Drinking Water |
| D019602 | Food and Beverages |
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