Örebro University
Örebro, Sweden
Location status: Recruiting
NCT Number: NCT07594600
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Örebro, Sweden
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 5 weeks
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
Time frame: 4 hours
Volatile organic compound profiles 4 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
Time frame: 6 hours
Volatile organic compound profiles 6 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
Time frame: 8 hours
Volatile organic compound profiles 8 hours after the start of the low fiber diet intervention compared with baseline (0 hours)
Time frame: 4 hours
Volatile organic compound profiles 4 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
Time frame: 6 hours
Volatile organic compound profiles 6 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
Time frame: 8 hours
Volatile organic compound profiles 8 hours after the start of the high fiber diet intervention compared with baseline (0 hours)
Time frame: 5 weeks
Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day low fiber diet
Time frame: 5 weeks
Assessment of Gastrointestinal pH measured by the alpHaONE JSPC-1 pH capsule, after a 3-day high fiber diet
Time frame: 1 week
Changes in fecal Volatile Organic Compound profiles produced during fecal fermentation, comparison of baseline (0 hours) profiles with profiles at 24 hours
Time frame: 1 Week
Changes in SCFA levels produced during fecal fermentation, comparison of baseline (0 hours) levels with levels at 24 hours
Time frame: 1 week
Changes in microbial enzymatic activity during fecal fermentation, comparison of baseline (0 hours) activity with activity at 24 hours
Time frame: 1 week
Microbiota composition at baseline (0 hours) compared with composition at 24 hours
Contact information is provided by the study sponsor or research team.
Natalie Sundberg PhD Student
CONTACT
Robert Brummer, Professor
CONTACT
Örebro University, Sweden
Other
Characterization of Fiber-degrading Microbiota in Individuals Without Gastrointestinal Diseases
Acronym: FIBRE-MATCH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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