Kombucha in Overweight and Obese: Live Vs. Pasteurized Effects on Microbiota, Metabolism, and Liver Function

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Pasteurized kombucha (non filtered): Participants receive a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (28 days).

Control (sparkling water): Participants receive a daily amount of 33 cl of sparkling water for 4 weeks.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Change in Gut microbiota composition and diversity (fecal samples) — 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 — 4 weeks
  Fasting glucose (mg/dl), from baseline to the end of intervention. Reduction is a better outcome.
• Change in fasting insulin levels — 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 — 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 — 4 weeks
  Lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides), in mg/dL, from baseline to the end of intervention.

Trial sites (2)

Other trials for the same condition