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| Name | Class |
|---|---|
| NutriLeads B.V. (Wageningen, The Netherlands) | UNKNOWN |
| ProDigest (Ghent, Belgium) | UNKNOWN |
| Ambiotis (Toulouse, France) | UNKNOWN |
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The aim of this study is to determine, quantify and understand the potential prebiotic effects of RG-I variants via microbiota modulation. The anti-inflammatory potential effects of these variants will also be investigated.
The plant cell wall derived RG-I (from chicory or carrot) and maltodextrin (placebo) in capsuled form will be provided by the food company NutriLeads B.V (Wageningen, The Netherlands), which has run tests of safety of the products and warranties their food grade quality and safety. The administration of RG-I will be done via a human intervention study of parallel arms, randomized, placebo - controlled, double blinded design (proof of concept study).
The dietary fibre from different RG-I sources will be tested for its prebiotic and immunomodulatory potential. Thus, the effects of these fibres on short chain fatty acid (SCFA) profile, microbiota composition, microbiota-associated metabolites and intestinal inflammatory markers will be investigated from fecal material obtained from the study participants.
The dietary fibre from different RG-I sources will be tested for their immunomodulatory and lifestyle related effects. The effects of fibres on immune activation markers will be investigated from blood samples collected from the study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants who will be randomized in the placebo group will receive maltodextrin (500mg/day). |
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| Chicory RG-I | Experimental | Participants who will be randomized in the placebo group will receive Chicory RG-I (500mg/day). |
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| Carrot RG-I | Experimental | Participants who will be randomized in the placebo group will receive Carrot RG-I (500mg/day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maltodextrin | Dietary Supplement | During the feeding period (4 weeks) two capsules/ day will be administered to subjects randomized in this group containing placebo powder with a breakfast item on a daily basis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the effect on selected intestinal microbial populations. | Selected microbial populations will be quantified with quantitative Polymerase Chain Reaction (PCR). | The levels of the selected microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period) |
| Change from baseline to the effect on the intestinal microbial populations. | Microbial populations will be quantified with 16SRNA sequencing. | The levels of the microbial populations will be measured weekly from baseline till the end of the interventional period.(4 weeks period) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the effect on the intestinal microbial populations's metabolic products [i.e. Short-Chain Fatty Acids (SCFA)]. | SCFAs will be quantified with Gas chromatography. | SCFAs levels will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Change from baseline to the effect on immune system reinforcement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus USÖ | Örebro | 703 62 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2023 | Sep 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Chicory RG-I | Dietary Supplement | During the feeding period (4 weeks) two capsules/ day will be administered to subjects randomized in this group containing chicory RG-I with a breakfast item on a daily basis. |
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| Carrot RG-I | Dietary Supplement | During the feeding period (4 weeks) two capsules/ day will be administered to subjects randomized in this group containing carrot RG-I with a breakfast item on a daily basis. |
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Plasmacytoid dendritic cells activation will be evaluated with flow cytometry. |
| Immune system reinforcement will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Change from baseline to the effect on inflammation. | Inflammatory related markers will be quantified by ELISA techniques. | Inflammation will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Change from baseline to the effect on exhaled volatile organic compounds levels. | Exhaled volatile organic compounds levels will be evaluated with Thermal Desorption Gas chromatography. | Exhaled volatile organic compounds levels will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Change from baseline to the effect on fecal metabolomic fingerprinting. | Metabolomic fingerprinting will be evaluated by applying laser assisted Rapid Evaporative Ionisation Mass Spectrometry (LA-REIMS) method on biological material. | Metabolomic fingerprinting will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Gastrointestinal tolerance of the supplement. | Gastrointestinal health will be evaluated with the use of a 1-day questionnaire consisting of 13 items concerning satiety, abdominal pain, diarrhea, constipation and bloating.The intensity of each parameter will be assessed on a scale of 0-7, where '0' represents absence of symptoms and '7' severe symptoms. | Gastrointestinal symptoms will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Dietary habits prior to the initiation of the study. | Dietary habits will be evaluated with the use of food frequency questionnaire (FFQ). | Dietary habits will be measured at baseline prior to the initiation of the study as background information. |
| Changes from baseline to the effect on physical activity levels. | Physical activity will be evaluated with the use of a validated questionnaire. IPAQ consists of 7 items questions concerning the duration and the intensity of physical activity so absolute numerical data will be obtained from it. | Physical activity will be evaluated at baseline and at the end of the intervention. (4 weeks period) |
| Changes from baseline to the effect on quality of life. | Quality of life will be evaluated with the use of a validated questionnaire. EQ-5D-5L consists of 5 items concerning mobility, self-care, usual activities, pain/discomfort, anxiety/depression.The overall score from this questionnaire will be calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (11,111, no problems on any dimension) to 25 (55,555, extreme problems on all dimensions). | Quality of life will be evaluated at baseline and at the end of the intervention. (4 weeks period) |