Clinical trial NCT05016596: Postprandial Lipids in IBS and Nutritional Treatment
Official title: Postprandial Lipids in IBS and Nutritional Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Ministry of Economic Affairs
name: Givaudan France Naturals
name: Nexira
name: Wecare
name: Roquette Freres
name: Ingredion Incorporated
name: Ingredia S.A.
name: Darling
name: Winclove Probiotics B.V.
name: Bioiberica
First posted: 2021-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: LPS_B
timeFrame: Baseline
measure: LBP_1
timeFrame: 1 hour post ingestion
measure: LPS_2
timeFrame: 2 hours post ingestion
measure: LPS_3
timeFrame: 3 hours post ingestion
measure: LPS_4
timeFrame: 4 hours post ingestion
measure: LPS_5
timeFrame: 5 hours post ingestion
Secondary outcomes:
measure: ApoB48_B
timeFrame: Baseline
measure: LPB_B
timeFrame: Baseline
measure: sCD14_B
timeFrame: Baseline
measure: ApoB48_1
timeFrame: 1 hour post ingestion
measure: LPB_1
timeFrame: 1 hour post ingestion
measure: sCD14_1
timeFrame: 1 hour post ingestion
measure: ApoB48_2
timeFrame: 2 hours post ingestion
measure: LPB_2
timeFrame: 2 hours post ingestion
measure: sCD14_2
timeFrame: 2 hours post ingestion
measure: ApoB48_3
timeFrame: 3 hours post ingestion
measure: LPB_3
timeFrame: 3 hours post ingestion
measure: sCD14_3
timeFrame: 3 hours post ingestion
measure: ApoB48_4
timeFrame: 4 hours post ingestion
measure: LPB_4
timeFrame: 4 hours post ingestion
measure: sCD14_4
timeFrame: 4 hours post ingestion
measure: ApoB48_5
timeFrame: 5 hours post ingestion
measure: LPB_5
timeFrame: 5 hours post ingestion
measure: sCD14_5
timeFrame: 5 hours post ingestion
Other outcomes:
measure: Age
timeFrame: Baseline
measure: BMI
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: GI complaints
timeFrame: Baseline
measure: IBS-related complaints (IBS-SSS)
timeFrame: Baseline
measure: Stool frequency-3
timeFrame: -72hr
measure: Stool frequency-2
timeFrame: -48hr
measure: Stool frequency-1
timeFrame: -24hr
measure: Stool frequency-T
timeFrame: Testday (0hr)
measure: Stool frequency+1
timeFrame: 24hr
measure: Stool frequency+2
timeFrame: 48hr
measure: Stool consistency-3
timeFrame: -72hr
measure: Stool consistency-2
timeFrame: -48hr
measure: Stool consistency-1
timeFrame: -24hr
measure: Stool consistency-T
timeFrame: Testday (0hr)
measure: Stool consistency+1
timeFrame: 24hr
measure: Stool consistency+2
timeFrame: 48hr
measure: Abdominal pain-3
timeFrame: -72hr
measure: Abdominal pain-2
timeFrame: -48hr
measure: Abdominal pain-1
timeFrame: -24hr
measure: Abdominal pain-T
timeFrame: Testday (0hr)
measure: Abdominal pain+1
timeFrame: 24hr
measure: Abdominal pain+2
timeFrame: 48hr
measure: Bloating-3
timeFrame: -72hr
measure: Bloating-2
timeFrame: -48hr
measure: Bloating-1
timeFrame: -24hr
measure: Bloating-T
timeFrame: Testday (0hr)
measure: Bloating+1
timeFrame: 24hr
measure: Bloating+2
timeFrame: 48hr
measure: Flatulence-3
timeFrame: -72hr
measure: Flatulence-2
timeFrame: -48hr
measure: Flatulence-1
timeFrame: -24hr
measure: Flatulence-T
timeFrame: Testday (0hr)
measure: Flatulence+1
timeFrame: 24hr
measure: Flatulence+2
timeFrame: 48hr
measure: Nausea-3
timeFrame: -72hr
measure: Nausea-2
timeFrame: -48hr
measure: Nausea-1
timeFrame: -24hr
measure: Nausea-T
timeFrame: Testday (0hr)
measure: Nausea+1
timeFrame: 24hr
measure: Nausea+2
timeFrame: 48hr
measure: Heartburn-3
timeFrame: -72hr
measure: Heartburn-2
timeFrame: -48hr
measure: Heartburn-1
timeFrame: -24hr
measure: Heartburn
timeFrame: Testday (0hr)
measure: Heartburn+1
timeFrame: 24hr
measure: Heartburn+2
timeFrame: 48hr
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
References: