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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B2 | Experimental | Daily dose of 75 mg Vitamin B2 |
|
| Vitamin C | Experimental | Daily dose of 500 mg Vitamin C |
|
| Vitamin B2 + C | Experimental | Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C |
|
| Vitamin A | Experimental | Daily dose of 250 µg Vitamin A |
|
| Vitamin D3 | Experimental | Daily dose of 60 µg Vitamin D3 |
|
| Vitamin E | Experimental | Daily dose of 100 mg Vitamin E |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B2 | Dietary Supplement | One capsule of 75 mg Vitamin B2 once a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from baseline to 4 weeks |
| Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing |
| Measure | Description | Time Frame |
|---|---|---|
| Electronic Gastrointestinal Symptom Rating Scale (GSRS) questionnaire | 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 | from baseline to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Dinan, Prof | Cork University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia | Cork | Blackpool Cork | T12HH60 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33615992 | Derived | Pham VT, Fehlbaum S, Seifert N, Richard N, Bruins MJ, Sybesma W, Rehman A, Steinert RE. Effects of colon-targeted vitamins on the composition and metabolic activity of the human gut microbiome- a pilot study. Gut Microbes. 2021 Jan-Dec;13(1):1-20. doi: 10.1080/19490976.2021.1875774. |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D001205 | Ascorbic Acid |
| D014801 | Vitamin A |
| D002762 | Cholecalciferol |
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Randomized, double-blind, placebo-controlled, parallel trial
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| Placebo | Placebo Comparator | Daily dose of 575 mg microcrystalline cellulose |
|
| Vitamin C | Dietary Supplement | One capsule of 500 mg Vitamin C once a day for 4 weeks |
|
| Vitamin B2 + C | Dietary Supplement | One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks |
|
| Vitamin A | Dietary Supplement | One capsule of 250 µg Vitamin A once a day for 4 weeks |
|
| Vitamin D3 | Dietary Supplement | One capsule of 60 µg Vitamin D3 once a day for 4 weeks |
|
|
| Vitamin E | Dietary Supplement | One capsule of 100 mg Vitamin E once a day for 4 weeks |
|
|
| Placebo | Dietary Supplement | One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks |
|
Changes from baseline in the treatment groups as compared to placebo of beta diversity assessed with shotgun sequencing (bray-curtis distance metrics) |
| 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) | 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) | 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) | from baseline to 4 weeks |
| Short Form 36 (SF-36) questionnaire |
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". |
| from baseline to 4 weeks |
| Volatile organic compound levels in fecal samples | Changes from baseline in the treatment groups as compared to placebo of volatile organic compounds (intensity) | from baseline to 4 weeks |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D024505 | Tocopherols |