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| Name | Class |
|---|---|
| Ministry of Economic Affairs | UNKNOWN |
| Givaudan France Naturals | INDUSTRY |
| Nexira | INDUSTRY |
| Wecare |
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Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. Adequate treatment is difficult, partially due to the heterogeneity of the patients and the complicated pathology in which not all mechanisms are understood. Based on literature and in vitro screening within the public private IBSQUtrition consortium project, a turmeric supplement was selected for in vivo validation of its potential beneficial effects on fat-induced intestinal barrier disruption as measured with LPS translocation in IBS patients with a diarrhea-predominant subtype (IBS-D).
The primary objective of this study is to determine the effect of turmeric supplementation on LPS translocation in IBS-D patients after a high-fat challenge. The secondary objective of this study is to determine the effect of turmeric supplementation on gastrointestinal complaints and LPS-related biomarkers in IBS-D patients after a high-fat challenge.
In this double-blind, randomized, placebo-controlled cross-over trial 20 adult (18-70 yrs) IBS-D patients will be included.
Study participants have to invest about 16 hours of their time in this study. They will visit the research facility three times. The risks for participation are very small if not negligible. Consumption of high amounts of saturated fat may cause some gastro-intestinal discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit painful and may cause a bruise. The amount of blood that is drawn from participants is relatively small and within acceptable limits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Acacia gum |
|
| turmeric | Experimental | Turmeric supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turmeric | Dietary Supplement | Turmeric supplement |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| LPS_B | LPS in venous blood samples collected at baseline | Baseline |
| LBP_1 | LBP in venous blood samples collected after high-fat shake consumption. | 1 hour post ingestion |
| LPS_2 | LPS in venous blood samples collected after high-fat shake consumption. | 2 hours post ingestion |
| LPS_3 | LPS in venous blood samples collected after high-fat shake consumption. | 3 hours post ingestion |
| LPS_4 | LPS in venous blood samples collected after high-fat shake consumption. | 4 hours post ingestion |
| LPS_5 | LPS in venous blood samples collected after high-fat shake consumption. | 5 hours post ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| ApoB48_B | ApoB48 at baseline | Baseline |
| LPB_B | LPB at baseline | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age | Baseline |
| BMI | BMI | Baseline |
| Gender |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University & Research | Wageningen | Gelderland | Netherlands |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| OTHER |
| Roquette Freres | INDUSTRY |
| Ingredion Incorporated | INDUSTRY |
| Ingredia S.A. | INDUSTRY |
| Darling | UNKNOWN |
| Winclove Probiotics B.V. | INDUSTRY |
| Bioiberica | INDUSTRY |
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| Dietary Supplement |
Placebo |
|
| sCD14_B |
sCD14 at baseline |
| Baseline |
| ApoB48_1 | ApoB48 after high-fat shake consumption | 1 hour post ingestion |
| LPB_1 | LPB after high-fat shake consumption | 1 hour post ingestion |
| sCD14_1 | sCD14 after high-fat shake consumption | 1 hour post ingestion |
| ApoB48_2 | ApoB48 after high-fat shake consumption | 2 hours post ingestion |
| LPB_2 | LPB after high-fat shake consumption | 2 hours post ingestion |
| sCD14_2 | sCD14 after high-fat shake consumption | 2 hours post ingestion |
| ApoB48_3 | ApoB48 after high-fat shake consumption | 3 hours post ingestion |
| LPB_3 | LPB after high-fat shake consumption | 3 hours post ingestion |
| sCD14_3 | sCD14 after high-fat shake consumption | 3 hours post ingestion |
| ApoB48_4 | ApoB48 after high-fat shake consumption | 4 hours post ingestion |
| LPB_4 | LPB after high-fat shake consumption | 4 hours post ingestion |
| sCD14_4 | sCD14 after high-fat shake consumption | 4 hours post ingestion |
| ApoB48_5 | ApoB48 after high-fat shake consumption | 5 hours post ingestion |
| LPB_5 | LPB after high-fat shake consumption | 5 hours post ingestion |
| sCD14_5 | sCD14 after high-fat shake consumption | 5 hours post ingestion |
Gender |
| Baseline |
| GI complaints | GI complaints | Baseline |
| IBS-related complaints (IBS-SSS) | Severity of IBS-related complaints (IBS-SSS), single score | Baseline |
| Stool frequency-3 | Stool frequency on test day -3 | -72hr |
| Stool frequency-2 | Stool frequency on test day -2 | -48hr |
| Stool frequency-1 | Stool frequency on test day -1 | -24hr |
| Stool frequency-T | Stool frequency on test day | Testday (0hr) |
| Stool frequency+1 | Stool frequency on test day +1 | 24hr |
| Stool frequency+2 | Stool frequency on test day +2 | 48hr |
| Stool consistency-3 | Stool consistency (Bristol stool chart) on test day -3 | -72hr |
| Stool consistency-2 | Stool consistency (Bristol stool chart) on test day -2 | -48hr |
| Stool consistency-1 | Stool consistency (Bristol stool chart) on test day -1 | -24hr |
| Stool consistency-T | Stool consistency (Bristol stool chart) on test day | Testday (0hr) |
| Stool consistency+1 | Stool consistency (Bristol stool chart) on test day +1 | 24hr |
| Stool consistency+2 | Stool consistency (Bristol stool chart) on test day +2 | 48hr |
| Abdominal pain-3 | Abdominal pain (Likert scale 0-10) on test day -3 | -72hr |
| Abdominal pain-2 | Abdominal pain (Likert scale 0-10) on test day -2 | -48hr |
| Abdominal pain-1 | Abdominal pain (Likert scale 0-10) on test day -1 | -24hr |
| Abdominal pain-T | Abdominal pain (Likert scale 0-10) on test day | Testday (0hr) |
| Abdominal pain+1 | Abdominal pain (Likert scale 0-10) on test day +1 | 24hr |
| Abdominal pain+2 | Abdominal pain (Likert scale 0-10) on test day +2 | 48hr |
| Bloating-3 | Bloating (Likert scale 0-10) on test day -3 | -72hr |
| Bloating-2 | Bloating (Likert scale 0-10) on test day -2 | -48hr |
| Bloating-1 | Bloating (Likert scale 0-10) on test day -1 | -24hr |
| Bloating-T | Bloating (Likert scale 0-10) on test day | Testday (0hr) |
| Bloating+1 | Bloating (Likert scale 0-10) on test day +1 | 24hr |
| Bloating+2 | Bloating (Likert scale 0-10) on test day +2 | 48hr |
| Flatulence-3 | Flatulence (Likert scale 0-10) on test day -3 | -72hr |
| Flatulence-2 | Flatulence (Likert scale 0-10) on test day -2 | -48hr |
| Flatulence-1 | Flatulence (Likert scale 0-10) on test day -1 | -24hr |
| Flatulence-T | Flatulence (Likert scale 0-10) on test day | Testday (0hr) |
| Flatulence+1 | Flatulence (Likert scale 0-10) on test day +1 | 24hr |
| Flatulence+2 | Flatulence (Likert scale 0-10) on test day +2 | 48hr |
| Nausea-3 | Nausea (Likert scale 0-10) on test day -3 | -72hr |
| Nausea-2 | Nausea (Likert scale 0-10) on test day -2 | -48hr |
| Nausea-1 | Nausea (Likert scale 0-10) on test day -1 | -24hr |
| Nausea-T | Nausea (Likert scale 0-10) on test day | Testday (0hr) |
| Nausea+1 | Nausea (Likert scale 0-10) on test day +1 | 24hr |
| Nausea+2 | Nausea (Likert scale 0-10) on test day +2 | 48hr |
| Heartburn-3 | Heartburn (Likert scale 0-10) on test day -3 | -72hr |
| Heartburn-2 | Heartburn (Likert scale 0-10) on test day -2 | -48hr |
| Heartburn-1 | Heartburn (Likert scale 0-10) on test day -1 | -24hr |
| Heartburn | Heartburn (Likert scale 0-10) on test day | Testday (0hr) |
| Heartburn+1 | Heartburn (Likert scale 0-10) on test day +1 | 24hr |
| Heartburn+2 | Heartburn (Likert scale 0-10) on test day +2 | 48hr |
| D004066 | Digestive System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |