The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
96
One capsule of 75 mg Vitamin B2 once a day for 4 weeks
One capsule of 500 mg Vitamin C once a day for 4 weeks
One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks
Atlantia
Cork, Blackpool Cork, Ireland
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)
Time frame: from baseline to 4 weeks
Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Changes from baseline in the treatment groups as compared to placebo of alpha diversity assessed with shotgun sequencing (Shannon diversity, Estimated ChaoI index)
Time frame: from baseline to 4 weeks
Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Changes from baseline in the treatment groups as compared to placebo of beta diversity assessed with shotgun sequencing (bray-curtis distance metrics)
Time frame: from baseline to 4 weeks
Short-chain fatty acids concentrations in fecal samples
Changes from baseline in the treatment groups as compared to placebo of short-chain fatty acids using GC-MS (mM)
Time frame: from baseline to 4 weeks
Ammonia concentrations in fecal samples
Changes from baseline in the treatment groups as compared to placebo of ammonia concentrations assessed with phenol-hypochlorite method (mg/L)
Time frame: from baseline to 4 weeks
Cytokines and chemokines in blood
Changes from baseline in the treatment group as compared to placebo of cytokines and chemokines using immune assays (pg/mL)
Time frame: from baseline to 4 weeks
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One capsule of 250 µg Vitamin A once a day for 4 weeks
One capsule of 60 µg Vitamin D3 once a day for 4 weeks
One capsule of 100 mg Vitamin E once a day for 4 weeks
One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks