University of Bath
Bath, Somerset, BA2 7AY, United Kingdom
Location status: Recruiting
NCT Number: NCT07837297
The goal of this clinical trial is to learn if adding a rapidly fermenting fibre to a meal containing a slow fermenting fibre affects gut bacterial fermentation and digestive comfort in healthy adults aged 18 to 85 years. The main questions it aims to answer are:
* Does the addition of a fast fermenting fibre to a meal containing a slow fermenting fibre change the timing and amount of gas produced by gut bacterial fermentation? * Does the addition of a fast fermenting fibre as a split dose effectively reduce the digestive discomfort typically caused by consuming a high dose of fibre all at once?
Researchers will compare the effect of adding fructo-oligosaccharides (FOS) over-and-above a single dietary fibre (soluble corn fibre). They will also compare whether taking FOS either all at once versus splitting it into two smaller doses affects gut bacterial fermentation and digestive comfort.
Participants will:
* Visit the research laboratory for 3 test days, with a 1-week break between visits. * Avoid certain foods and fast overnight before each test day. * Eat a test breakfast and lunch containing the dietary fibres in different parts of the meal. * Provide breath samples every 30 minutes to measure gas produced by gut bacteria. * Answer survey questions about their digestive comfort every 30 minutes. * Keep a diary of their bowel movements for 5 days during each test cycle.
Short-chain fatty acids (SCFAs) produced through dietary fibre fermentation are essential for maintaining intestinal barrier integrity and regulating systemic metabolism; however, average daily fibre intake frequently remains below recommended levels. While supplementing with highly fermentable fibres, such as fructo-oligosaccharides (FOS), effectively stimulates beneficial microbial activity in the proximal colon, their rapid breakdown often triggers acute gastrointestinal discomfort, including bloating and flatulence. Conversely, soluble corn fibre (SCF) possesses a highly branched structure that ferments slowly and reaches the distal colon, exhibiting excellent gastrointestinal tolerability but yielding a lower initial peak of SCFA production.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Bath, Somerset, BA2 7AY, United Kingdom
Location status: Recruiting
This study aims to investigate the effect of rapidly fermenting FOS over-and-above slowly fermenting SCF and whether this supports a "spatio-temporal fermentation profile" spanning the entire colonic tract. By balancing fermentation speeds, this strategy holds the potential to maximise total colonic fermentation yield whilst mitigating the adverse symptoms typically associated with isolated high-dose FOS intake. Furthermore, the study explores a split-dosing regimen as an additional temporal strategy; dividing the FOS intake may limit the peak rate of gas production, preventing it from exceeding the gut's natural gas clearance mechanisms, while ensuring a sustained delivery of fermentable substrates.
To evaluate these physiological dynamics, healthy adult participants will complete a randomised, double-blind, crossover trial comprising three distinct acute testing days, separated by 7-day washout periods. Under strict dietary standardisation and overnight fasting conditions, participants will consume meals containing specific dietary fibres. The acute physiological responses will be continuously monitored via non-invasive breath hydrogen and methane analysis to objectively map fermentation kinetics, alongside regular self-reported assessments of gastrointestinal tolerability throughout the testing window.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of SCF with breakfast.
Administration of FOS as a single dose over-and-above SCF with breakfast.
Administration of FOS at breakfast and at lunch, over-and-above SCF at breakfast.
Time frame: Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day
Total colonic fermentation yield is evaluated by measuring breath hydrogen and methane concentrations. Breath samples are collected at 30-minute intervals post-intervention using Omed breath analysers. The total production for both gases is quantified independently by calculating their respective AUC values from the averaged concentration-time profiles.
Time frame: Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day.
The dynamic temporal characteristics of gut fermentation are evaluated by determining the maximum peak concentration (Cmax) for both breath hydrogen and methane. Data is extracted from continuous breath samples collected using Omed breath analysers.
Time frame: Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day.
The dynamic temporal characteristics of gut fermentation are evaluated by determining the time required to reach this peak concentration (Tmax) for both breath hydrogen and methane. Data is extracted from continuous breath samples collected using Omed breath analysers.
Time frame: Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day.
The incidence and severity of subjective GI symptoms (bloating, abdominal cramping, stomach noises/borborygmi, and flatulence) are rated by participants on a scale from 0 (absent) to 10 (extremely severe). Any bowel movements are logged and converted into a stool score from 0 (normal transit) to 10 (diarrhoea). These are summed to calculate a total composite score ranging from 0 to 50, with higher scores indicating worse GI tolerability.
Time frame: Baseline (fasting) and every 30 minutes up to 8 hours on each acute test day.
Participants monitor and log their daily bowel movement frequency and utilise the Bristol Stool Scale (BSS) to objectively assess stool consistency and appearance. This tracks delayed lower gastrointestinal responses beyond the immediate acute testing window.
Interested in participating?
Request InfoUniversity of Bath
Other
Acute Effects of Different Dietary Fibres on Gut Fermentation: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT07826650
Dyssomnias, Healthy Adult
Hong Kong
View Trial DetailsNCT07827664
Dyssomnias, Healthy Adult
Hong Kong
View Trial DetailsNCT07831499
Brain, Healthy Adult
Aurora, Colorado, United States
View Trial DetailsNCT07827677
Dyssomnias, Exercise Induced Muscle Damage
Hong Kong
View Trial Details