NCT05016596

Postprandial Lipids in IBS and Nutritional Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	turmeric	Turmeric supplement
DIETARY_SUPPLEMENT	placebo	Placebo

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2021-08-23
• Last updated: 2022-04-21

Locations

1 site across 1 country: Netherlands