Atlantia
Cork, Blackpool Cork, T12HH60, Ireland
NCT Number: NCT03668964
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.
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Cork, Blackpool Cork, T12HH60, Ireland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One capsule of 75 mg Vitamin B2 once a day for 4 weeks
Other names: Riboflavin
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
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
Other names: Cholecalciferol
One capsule of 100 mg Vitamin E once a day for 4 weeks
Other names: alpha-tocopherol
One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks
Time frame: from baseline to 4 weeks
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
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
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
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
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
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
Changes from baseline in the treatment groups as compared to placebo of the GSRS. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms
Time frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of the quality of life questionnaire Short Form 36 (SF-36) questionnaire. The Short Form (SF)-36 generates a profile of health-related quality of life outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0 to 100; where 100 indicates "good health".
Time frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of volatile organic compounds (intensity)
dsm-firmenich Switzerland AG
Industry
A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults
Acronym: VitaGut
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.
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