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

Официальное название

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]

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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).
• Пищевая добавка Pasteurized kombucha (non filtered)
  Participants receive a daily amount of 33 cl of kombucha (pasteurized drink) for 4 weeks (28 days).
• Другое Control (sparkling water)
  Participants receive a daily amount of 33 cl of sparkling water for 4 weeks.

Первичные конечные точки

• Change in Gut microbiota composition and diversity (fecal samples) [Срок оценки: 4 weeks]
• Change in fasting glucose levels [Срок оценки: 4 weeks]
• Change in fasting insulin levels [Срок оценки: 4 weeks]
• Changes in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) values [Срок оценки: 4 weeks]
• Changes in Lipid profile [Срок оценки: 4 weeks]

Вторичные конечные точки (9)

• Stool consistency rating by Bristol Stool Scale [Срок оценки: 4 weeks]
• Variation in SIBO diagnosis (positive/negative) measured by methane and hydrogen levels in breath test [Срок оценки: 4 weeks]
• Change in liver enzyme levels [Срок оценки: 4 weeks]
• Change in levels of oxidative stress biomarker (ratio 8-iso-PGF2α to prostaglandin F2α (PGF2α)) [Срок оценки: 4 weeks]
• Change in gastrointestinal symptoms using a Likert scale [Срок оценки: 4 weeks]
• Change in high-sensitive C-reactive protein levels [Срок оценки: 4 weeks]
• Change in Total oxidant capacity [Срок оценки: 4 weeks]
• Changes in serum albumin and bilirubin levels [Срок оценки: 4 weeks]
• Changes in short chain fatty acids in stool [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

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);
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Португалия · 2 центра

• Centro de Apoio Tecnológico Agro Alimentar (CATAA) — Castelo Branco
• Centro de Apoio Tecnológico Agro Alimentar (CATAA) (facilities temporarily provided by the — Covilha

Публикации

• 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. PMID 36095960

Идентификаторы

NCT: NCT06759324 · FUSILLI: PARECER (02/2024) · Grant agreement No. 101000717

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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