The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals (FIBRE-MATCH)
Characterization of Fiber-degrading Microbiota in Individuals Without Gastrointestinal Diseases
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Natalie Sundberg PhD Student
- Número de teléfono: +46 704670585
- Correo electrónico: natalie.sundberg@oru.se
Copia de seguridad de contactos de estudio
- Nombre: Robert Brummer, Professor
- Número de teléfono: +46 738426600
- Correo electrónico: Robert.Brummer@oru.se
Ubicaciones de estudio
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Örebro, Suecia
- Reclutamiento
- Örebro university
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Contacto:
- Natalie Sundberg
- Correo electrónico: fibrematch@oru.se
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Low Fiber Diet, Then High Fiber Diet
Participants will receive a whole food dietary fiber product to consume 10g of dietary fiber per day over a total of 3 days, equal to a high fiber diet.
After a washout period of 3 weeks, they then receive the same whole food dietary fiber product, to consume 40g of dietary fiber per day in a total of 3 days, equal to a high fiber diet.
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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 |
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Experimental: High Fiber Diet, Then Low Fiber Diet
Participants will receive a whole food dietary fiber product to consume 40g of dietary fiber per day over a total of 3 days, equal to a high fiber diet.
After a washout period of 3 weeks, they then receive the same whole food dietary fiber product, to consume 10g of dietary fiber per day in a total of 3 days, equal to a high fiber diet.
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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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 5 weeks
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Volatile Organic Compound profiles in produced by the 3-day low fiber diet intervention compared to the profiles produced by the 3-day high fiber diet, with a 3-week washout inbetween
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5 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of a low fiber diet on Volatile Organic Compound profiles after 4 hours
Periodo de tiempo: 4 hours
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Volatile organic compound profiles 4 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
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4 hours
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Effect of a low fiber diet on Volatile Organic Compound profiles after 6 hours
Periodo de tiempo: 6 hours
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Volatile organic compound profiles 6 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
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6 hours
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Effect of a low fiber diet on Volatile Organic Compound profiles after 8 hours
Periodo de tiempo: 8 hours
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Volatile organic compound profiles 8 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
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8 hours
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Effect of a high fiber diet on Volatile Organic Compound profiles after 4 hours
Periodo de tiempo: 4 hours
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Volatile organic compound profiles 4 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
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4 hours
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Effect of a high fiber diet on Volatile Organic Compound profiles after 6 hours
Periodo de tiempo: 6 hours
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Volatile organic compound profiles 6 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
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6 hours
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Effect of a high fiber diet on Volatile Organic Compound profiles after 8 hours
Periodo de tiempo: 8 hours
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Volatile organic compound profiles 8 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
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8 hours
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Gastrointestinal pH after a 3-day low fiber diet
Periodo de tiempo: 5 weeks
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Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day low fiber diet
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5 weeks
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Gastrointestinal pH after a 3-day high fiber diet
Periodo de tiempo: 5 weeks
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Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day high fiber diet
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5 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fecal Volatile Organic Compound profiles
Periodo de tiempo: 1 week
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Changes in fecal Volatile Organic Compound profiles produced during fecal fermentation, comparison of baseline (0 hours) profiles with profiles at 24 hours
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1 week
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SCFA
Periodo de tiempo: 1 Week
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Changes in SCFA levels produced during fecal fermentation, comparison of baseline (0 hours) levels with levels at 24 hours
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1 Week
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Microbial enzymatic activity
Periodo de tiempo: 1 week
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Changes in microbial enzymatic activity during fecal fermentation, comparison of baseline (0 hours) activity with activity at 24 hours
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1 week
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Microbiota composition
Periodo de tiempo: 1 week
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Microbiota composition at baseline (0 hours) compared with composition at 24 hours
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1 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Robert Brummer, Professor, Örebro University, Sweden
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026-00408-01
- 101161484 (Otro número de subvención/financiamiento: European Innovation Council (EIC))
Información sobre medicamentos y dispositivos, documentos del estudio
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