Postprandial Lipids in IBS and Nutritional Treatment

IBS - Irritable Bowel Syndrome Clinical Trial

— PLINT  

Official title:

Postprandial Lipids in IBS and Nutritional Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016596
• Other study ID #: NL75915.041.21
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2022
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• turmeric
Turmeric supplement
• placebo
Placebo

Locations

Country	Name	City	State
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (11)

Lead Sponsor	Collaborator
Wageningen University and Research	Bioiberica, Darling, Ingredia S.A., Ingredion Incorporated, Ministry of Economic Affairs, Naturex SA, Nexira, Roquette Freres, Wecare, Winclove Probiotics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age	Baseline
Other	BMI	BMI	Baseline
Other	Gender	Gender	Baseline
Other	GI complaints	GI complaints	Baseline
Other	IBS-related complaints (IBS-SSS)	Severity of IBS-related complaints (IBS-SSS), single score	Baseline
Other	Stool frequency-3	Stool frequency on test day -3	-72hr
Other	Stool frequency-2	Stool frequency on test day -2	-48hr
Other	Stool frequency-1	Stool frequency on test day -1	-24hr
Other	Stool frequency-T	Stool frequency on test day	Testday (0hr)
Other	Stool frequency+1	Stool frequency on test day +1	24hr
Other	Stool frequency+2	Stool frequency on test day +2	48hr
Other	Stool consistency-3	Stool consistency (Bristol stool chart) on test day -3	-72hr
Other	Stool consistency-2	Stool consistency (Bristol stool chart) on test day -2	-48hr
Other	Stool consistency-1	Stool consistency (Bristol stool chart) on test day -1	-24hr
Other	Stool consistency-T	Stool consistency (Bristol stool chart) on test day	Testday (0hr)
Other	Stool consistency+1	Stool consistency (Bristol stool chart) on test day +1	24hr
Other	Stool consistency+2	Stool consistency (Bristol stool chart) on test day +2	48hr
Other	Abdominal pain-3	Abdominal pain (Likert scale 0-10) on test day -3	-72hr
Other	Abdominal pain-2	Abdominal pain (Likert scale 0-10) on test day -2	-48hr
Other	Abdominal pain-1	Abdominal pain (Likert scale 0-10) on test day -1	-24hr
Other	Abdominal pain-T	Abdominal pain (Likert scale 0-10) on test day	Testday (0hr)
Other	Abdominal pain+1	Abdominal pain (Likert scale 0-10) on test day +1	24hr
Other	Abdominal pain+2	Abdominal pain (Likert scale 0-10) on test day +2	48hr
Other	Bloating-3	Bloating (Likert scale 0-10) on test day -3	-72hr
Other	Bloating-2	Bloating (Likert scale 0-10) on test day -2	-48hr
Other	Bloating-1	Bloating (Likert scale 0-10) on test day -1	-24hr
Other	Bloating-T	Bloating (Likert scale 0-10) on test day	Testday (0hr)
Other	Bloating+1	Bloating (Likert scale 0-10) on test day +1	24hr
Other	Bloating+2	Bloating (Likert scale 0-10) on test day +2	48hr
Other	Flatulence-3	Flatulence (Likert scale 0-10) on test day -3	-72hr
Other	Flatulence-2	Flatulence (Likert scale 0-10) on test day -2	-48hr
Other	Flatulence-1	Flatulence (Likert scale 0-10) on test day -1	-24hr
Other	Flatulence-T	Flatulence (Likert scale 0-10) on test day	Testday (0hr)
Other	Flatulence+1	Flatulence (Likert scale 0-10) on test day +1	24hr
Other	Flatulence+2	Flatulence (Likert scale 0-10) on test day +2	48hr
Other	Nausea-3	Nausea (Likert scale 0-10) on test day -3	-72hr
Other	Nausea-2	Nausea (Likert scale 0-10) on test day -2	-48hr
Other	Nausea-1	Nausea (Likert scale 0-10) on test day -1	-24hr
Other	Nausea-T	Nausea (Likert scale 0-10) on test day	Testday (0hr)
Other	Nausea+1	Nausea (Likert scale 0-10) on test day +1	24hr
Other	Nausea+2	Nausea (Likert scale 0-10) on test day +2	48hr
Other	Heartburn-3	Heartburn (Likert scale 0-10) on test day -3	-72hr
Other	Heartburn-2	Heartburn (Likert scale 0-10) on test day -2	-48hr
Other	Heartburn-1	Heartburn (Likert scale 0-10) on test day -1	-24hr
Other	Heartburn	Heartburn (Likert scale 0-10) on test day	Testday (0hr)
Other	Heartburn+1	Heartburn (Likert scale 0-10) on test day +1	24hr
Other	Heartburn+2	Heartburn (Likert scale 0-10) on test day +2	48hr
Primary	LPS_B	LPS in venous blood samples collected at baseline	Baseline
Primary	LBP_1	LBP in venous blood samples collected after high-fat shake consumption.	1 hour post ingestion
Primary	LPS_2	LPS in venous blood samples collected after high-fat shake consumption.	2 hours post ingestion
Primary	LPS_3	LPS in venous blood samples collected after high-fat shake consumption.	3 hours post ingestion
Primary	LPS_4	LPS in venous blood samples collected after high-fat shake consumption.	4 hours post ingestion
Primary	LPS_5	LPS in venous blood samples collected after high-fat shake consumption.	5 hours post ingestion
Secondary	ApoB48_B	ApoB48 at baseline	Baseline
Secondary	LPB_B	LPB at baseline	Baseline
Secondary	sCD14_B	sCD14 at baseline	Baseline
Secondary	ApoB48_1	ApoB48 after high-fat shake consumption	1 hour post ingestion
Secondary	LPB_1	LPB after high-fat shake consumption	1 hour post ingestion
Secondary	sCD14_1	sCD14 after high-fat shake consumption	1 hour post ingestion
Secondary	ApoB48_2	ApoB48 after high-fat shake consumption	2 hours post ingestion
Secondary	LPB_2	LPB after high-fat shake consumption	2 hours post ingestion
Secondary	sCD14_2	sCD14 after high-fat shake consumption	2 hours post ingestion
Secondary	ApoB48_3	ApoB48 after high-fat shake consumption	3 hours post ingestion
Secondary	LPB_3	LPB after high-fat shake consumption	3 hours post ingestion
Secondary	sCD14_3	sCD14 after high-fat shake consumption	3 hours post ingestion
Secondary	ApoB48_4	ApoB48 after high-fat shake consumption	4 hours post ingestion
Secondary	LPB_4	LPB after high-fat shake consumption	4 hours post ingestion
Secondary	sCD14_4	sCD14 after high-fat shake consumption	4 hours post ingestion
Secondary	ApoB48_5	ApoB48 after high-fat shake consumption	5 hours post ingestion
Secondary	LPB_5	LPB after high-fat shake consumption	5 hours post ingestion
Secondary	sCD14_5	sCD14 after high-fat shake consumption	5 hours post ingestion