Postprandial Lipids in IBS and Nutritional Treatment (PLINT)

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.

Study Overview

• Status: Completed
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: turmeric

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands
      • Wageningen University & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IBS patients that meet the Rome IV criteria + additional criteria specific for the diarrhea-predominant subtype, based on the most frequent self-reported stool types using the Bristol stool chart
• Male and female adults, aged 18-70 years;
• Having a Body Mass Index (BMI) between 18.5 and 30 kg/m2;
• Willing to keep a stable dietary pattern throughout the study.

Exclusion Criteria:

• Having a disease that may interfere with the outcomes of this study, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism.
• History of intestinal surgery (excluding appendectomy or cholecystectomy) or endometriosis.
• Use of medication that can interfere with the study outcomes, including codeine and antibiotics, as judged by the medical supervisor.
• Use of anticoagulants (as curcumin has inhibitory effects on platelet aggregation).
• Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other supplements dedicated to bowel function improvements.
• Having swallowing problems with pills/capsules.
• Having a cow's milk allergy or other food allergies.
• If applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study.
• Participation in another clinical trial at the same time.
• Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition & Health, Wageningen University.
• Alcohol intake ≥ 14 (women) or ≥ 28 (men) glasses of alcoholic beverages per week.
• Smoking and abuse of illicit drugs, soft drugs, and/or nitrous oxide.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Acacia gum	Dietary supplement: placebo; Placebo
Experimental: turmeric; Turmeric supplement	Dietary supplement: turmeric; Turmeric supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ApoB48_B	ApoB48 at baseline	Baseline
LPB_B	LPB at baseline	Baseline
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age	Baseline
BMI	BMI	Baseline
Gender	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

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Nexira; Roquette Freres; Bioiberica; Ingredion Incorporated; Winclove Probiotics B.V.; Wecare; Ingredia S.A.; Naturex SA; Ministry of Economic Affairs; Darling

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: NL75915.041.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No