soluble wheat bran fibre
Dietary Supplement12 weeks daily intake of 15g of soluble wheat bran fibre
NCT Number: NCT02491125
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 weeks daily intake of 15g of soluble wheat bran fibre
12 weeks daily intake of 15g of maltodextrin
Other names: Maltodextrin
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Whole gut transit time as measured by radio-opaque marker method
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Gastric emptying measured by isotope breath test
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Oro-cecal transit time measured by hydrogen breath test
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Defecation frequency as measured via questionnaire
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Energy expenditure measured by indirect calorimetry
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Fat and carbohydrate oxidation measured by indirect calorimetry
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Adipose tissue gene expression measured by quantitative real time polymerase chain reaction
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Gut permeability as measured by multi sugar assay
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Microbiota composition as measured by illumina sequencing in feces
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry
Maastricht University Medical Center
Other
Effect of Prebiotic Fibre on Intestinal Health and Functioning
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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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