Postprandial Lipids in IBS and Nutritional Treatment

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

DIETARY_SUPPLEMENT

turmeric

Turmeric supplement

DIETARY_SUPPLEMENT

placebo

Placebo

Sponsors & Collaborators

• Ministry of Economic Affairs

  collaborator UNKNOWN

• Givaudan France Naturals

  collaborator INDUSTRY

• Nexira

  collaborator INDUSTRY

• Wecare

  collaborator OTHER

• Roquette Freres

  collaborator INDUSTRY

• Ingredion Incorporated

  collaborator INDUSTRY

• Ingredia S.A.

  collaborator INDUSTRY

• Darling

  collaborator UNKNOWN

• Winclove Probiotics B.V.

  collaborator INDUSTRY

• Bioiberica

  collaborator INDUSTRY

• Wageningen University and Research

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2022-04-11

Completion

2022-04-11

Countries

• Netherlands

Study Locations