Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Официальное название

Impact of Fermented Pulses on Inflammation and the Gut Microbiota

Обзор

The goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. The main questions it aims to answer are: 1. How does consuming the fermented foods impact the gut microbiome? 2. Does this interaction between the fermented foods and the gut microbiome affect inflammation? Participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses. Researchers will compare the gut microbiome and inflammation between these two diets.

Подробное описание

The rationale for the research is that fermentation of pulses can reduce the concentration of compounds that suppress butyrate producing bacteria and butyrate production. This will in turn boost butyrate production during consumption of these fermented pulses relative to that in unfermented pulses. This in turn will lead to lower inflammation in people consuming fermented pulses. To best study this question the investigators will utilize a cross-over design trial where participants will consume daily meals containing either fermented or unfermented pulses (chickpeas), followed by a washout period and then a period of consuming the other type of pulse. The investigators hypothesize that those consuming the fermented pulses will experience a significant decrease in inflammatory markers driven by increased butyrate production by gut bacteria.

Вмешательства

• Другое Unfermented chickpea
  Frozen meals containing 100 g unfermented chickpeas
• Другое Fermented chickpea
  Frozen meals containing 100 g fermented chickpeas

Первичные конечные точки

• Change in inflammation levels from baseline and between interventions [Срок оценки: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)]

Вторичные конечные точки (2)

• Change in fecal short chain fatty acids from baseline and between interventions [Срок оценки: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)]
• Change in gut microbiome composition from baseline and between interventions [Срок оценки: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)]

Критерии участия

Критерии включения

• Healthy adults

Критерии исключения

• Taken antibiotics within the past month
• Taking any medication for the management of diabetes or obesity
• Are pregnant
• BMI > 24.9
• Allergies to pulses or any other meal components

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06134076 · STUDY00023162 · 58-3060-3-052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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