The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals

Официальное название

Characterization of Fiber-degrading Microbiota in Individuals Without Gastrointestinal Diseases

Обзор

The aim of this crossover intervention study is to evaluate the volatile organic compounds (VOCs) present in participants at baseline and how these levels change after consuming either a low- or high-dietary fiber diet for three days. This study will involve adults, 18-65 years old, without any gastrointestinal diseases. The primary objectives are to characterize baseline VOC profiles, assess changes in these profiles after a short-term dietary fiber intervention, determine if specific VOC patterns correlate with dietary fiber intake, and identify the time points at which VOC levels peak. This information will help establish the optimal timing for breath sampling and potentially provide insight into how VOC patterns relate to dietary fiber consumption and degradation. The expected outcome is that a high-dietary fiber diet will produce a VOC profile enriched in metabolites associated with fiber fermentation compared to a low-dietary fiber diet, and that these VOCs will be consistent with those identified in vitro during fecal fermentation. Each participant will serve as an internal control, enabling within-subject comparisons of VOC levels at baseline and following the dietary fiber intervention. Participants will receive a whole-food product that is rich in dietary fiber and will consume either a low-fiber diet (10 g/day) or a high-fiber diet (40 g/day) for three days. On the first day of each intervention, participants will also ingest a pH capsule to monitor gastrointestinal pH continuously throughout the three days. After a three-week washout period, participants will cross over to the other intervention arm and undergo another round of gastrointestinal pH monitoring. In addition to the dietary intervention, participants will complete food and health questionnaires to assess habitual fiber intake and dietary habits. Fecal samples will be collected for in vitro fermentation to functionally profile the gut microbiota by assessing fecal VOCs, short-chain fatty acids (SCFA), and the microbial enzymatic activity and its pH-dependent modulation.

Вмешательства

• Другое Low, High Fiber Diet
  Dietary Intervention: Low Fiber Diet Whole food dietary fiber product, 10g of dietary fiber consumed per day for 3 days Dietary Intervention: High Fiber Diet Whole food dietary fiber product, 40g of dietary fiber consumed per day for 3 days
• Другое High, Low Fiber Diet
  Dietary Intervention: High Fiber Diet Whole food dietary fiber product, 40g of dietary fiber consumed per day for 3 days Dietary Intervention: Low Fiber Diet Whole food dietary fiber product, 10g of dietary fiber consumed per day for 3 days

Первичные конечные точки

• Effect of a 3-day low fiber diet compared to a 3-day high fiber diet on the Volatile Organic Compound profiles in exhaled breath [Срок оценки: 5 weeks]

Вторичные конечные точки (8)

• Effect of a low fiber diet on Volatile Organic Compound profiles after 4 hours [Срок оценки: 4 hours]
• Effect of a low fiber diet on Volatile Organic Compound profiles after 6 hours [Срок оценки: 6 hours]
• Effect of a low fiber diet on Volatile Organic Compound profiles after 8 hours [Срок оценки: 8 hours]
• Effect of a high fiber diet on Volatile Organic Compound profiles after 4 hours [Срок оценки: 4 hours]
• Effect of a high fiber diet on Volatile Organic Compound profiles after 6 hours [Срок оценки: 6 hours]
• Effect of a high fiber diet on Volatile Organic Compound profiles after 8 hours [Срок оценки: 8 hours]
• Gastrointestinal pH after a 3-day low fiber diet [Срок оценки: 5 weeks]
• Gastrointestinal pH after a 3-day high fiber diet [Срок оценки: 5 weeks]

Критерии участия

Критерии включения

• Signed informed consent obtained prior to any study-related procedures.
• Willingness to refrain from regular consumption of prebiotic or probiotic products, as well as medications known to affect gastrointestinal function, for at least four weeks prior to the study visits.

Критерии исключения

• History of complicated gastrointestinal surgery.
• Presence of a gastrointestinal diagnosis or any condition that, in the opinion of the principal investigator, may influence the study outcomes.
• Current diagnosis of a psychiatric disorder.
• Systemic use of antibiotics or steroid medications within the past 3 months.
• Frequent use of NSAIDs (non-steroidal anti-inflammatory drugs) within the 2 months preceding the study visit.
• Regular consumption of prebiotic or probiotic products within the past 4 weeks.
• Alcohol or substance abuse.
• Current smoking or use of nicotine pouches.
• Frequent use of laxatives, antidiarrheal agents, or anticholinergic medications within the 12 weeks preceding the study visit.
• Pregnancy or breastfeeding.
• Respiratory disease or infection.

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

Швеция · 1 центр

• Örebro University — Örebro

Идентификаторы

NCT: NCT07594600 · 2026-00408-01 · 101161484

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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