Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults (GutFood)

Официальное название

'GutFood' - Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults

Обзор

Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes. Nutritional inadequacies, including low dietary fibre intake and suboptimal B-vitamin status, are common in older adults and may contribute to these age-related health issues. Research suggests that increasing dietary fibre intake, particularly through prebiotics such as inulin, may help to improve gut health. In addition, B-vitamins have been linked to both gut and mental health, although their combined effects with prebiotics are not well understood. With the assistance of a food company, the investigators have developed a functional drink enriched with chicory inulin, alone or in combination with B-vitamins. Therefore, the investigators plan to conduct a 12-week randomised, double-blind, placebo-controlled trial to test the effect of this functional drink on gut health outcomes, nutritional status, inflammation, and mental health in adults aged 50 years and older.

Вмешательства

• Пищевая добавка Inulin and B-vitamins
  A functional beverage containing inulin (7.5 g per serving) combined with B-vitamins folic acid (100μg), vitamin B12 (5μg), vitamin B6 (5mg) and riboflavin (2.5mg).
• Пищевая добавка Inulin
  A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.
• Пищевая добавка Placebo
  A control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.

Первичные конечные точки

• Gut microbiome profile [Срок оценки: 12 weeks]
• Serum total homocysteine [Срок оценки: 12 weeks]
• Folate [Срок оценки: 12 weeks]
• Vitamin B12 [Срок оценки: 12 weeks]
• Vitamin B6 [Срок оценки: 12 weeks]
• Riboflavin [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• Inflammation [Срок оценки: 12 weeks]
• Gut microbial metabolites [Срок оценки: 12 weeks]
• Depressive symptoms [Срок оценки: 12 weeks]
• Anxiety symptoms [Срок оценки: 12 weeks]
• Sleep quality [Срок оценки: 12 weeks]
• Physiological stress [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Community-dwelling
• Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins
• Individuals with the capacity to provide informed consent

Критерии исключения

• B12 injection users
• Using supplements containing the nutrients of interest (B-vitamins, inulin, probiotics)
• Taking medications that interfere with B-vitamin metabolism
• Currently taking antibiotics
• GI disease (Crohn's, coeliac)
• Serious chronic disease (e.g. cancer, liver disease)

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

Великобритания · 1 центр

• Human Intervention Studies Unit — Coleraine

Идентификаторы

NCT: NCT07592975 · REC/24/0064

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗