GOS and the Management of Hyperuricemia

Официальное название

The Effectiveness of Galactooligosaccharide on the Treatment of Hyperuricemia

Обзор

Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel therapeutic target for hyperuricemia. Both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. This trial aims to examine the protective effects and potential mechanisms of galactooligosaccharide on hyperuricemia in clinical trials.

Подробное описание

Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids and hippuric acid.

However, whether administration of galactooligosaccharide also has a protective effect in subjects with hyperuricemia remain under-explored. Moreover, the molecular mechanisms underlying the protective effect of galactooligosaccharide remains largely unknown.

Вмешательства

• Пищевая добавка GOS
  During the study period, subjects are instructed to take one pocket of galactooligosaccharide per day during the first week, followed by two pockets of galactooligosaccharide per day during the remaining 7 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity.
• Пищевая добавка Placebo
  During the study period, subjects are instructed to take one pocket of placebo control per day during the first week, followed by two pockets of placebo control per day during the remaining 7 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity.

Первичные конечные точки

• Change of serum uric acid [Срок оценки: from baseline to 8 weeks after intervention]
• Change of excretion of uric acid [Срок оценки: from baseline to 8 weeks after intervention]

Вторичные конечные точки (2)

• Change of gut microbiota [Срок оценки: from baseline to 8 weeks after intervention]
• Change of microbial metabolites in the circulation [Срок оценки: from baseline to 8 weeks after intervention]

Критерии участия

Критерии включения

• Local residents aged between 18-80 years old;
• Stable weight (<5% weight change over the past 3 months);
• Fasting uric acid > 420 umol/L for male and > 360 umol/L for female on two different days;
• Not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment;
• Absence of any diet or medication that might interfere with uric acid metabolism or gut microbiota, especially antibiotics, prebiotics or probiotics at the least 4 weeks before recruitment

Критерии исключения

• Acute illness or evidence of any acute or chronic inflammatory of infective diseases;
• Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
• Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study;
• Women of childbearing age who are pregnant, breast-feeding or preparing for pregnancy; patients who had surgey within the past 6 months or planned surgery during the trial period.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06630377 · GOS-HUA-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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