Postprandial Lipids in IBS and Nutritional Treatment (PLINT)
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
turmeric
placebo
Sponsored by
About this trial
This is an interventional prevention trial for IBS - Irritable Bowel Syndrome
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.
Sites / Locations
- Wageningen University & Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
turmeric
Arm Description
Acacia gum
Turmeric supplement
Outcomes
Primary Outcome Measures
LPS_B
LPS in venous blood samples collected at baseline
LBP_1
LBP in venous blood samples collected after high-fat shake consumption.
LPS_2
LPS in venous blood samples collected after high-fat shake consumption.
LPS_3
LPS in venous blood samples collected after high-fat shake consumption.
LPS_4
LPS in venous blood samples collected after high-fat shake consumption.
LPS_5
LPS in venous blood samples collected after high-fat shake consumption.
Secondary Outcome Measures
ApoB48_B
ApoB48 at baseline
LPB_B
LPB at baseline
sCD14_B
sCD14 at baseline
ApoB48_1
ApoB48 after high-fat shake consumption
LPB_1
LPB after high-fat shake consumption
sCD14_1
sCD14 after high-fat shake consumption
ApoB48_2
ApoB48 after high-fat shake consumption
LPB_2
LPB after high-fat shake consumption
sCD14_2
sCD14 after high-fat shake consumption
ApoB48_3
ApoB48 after high-fat shake consumption
LPB_3
LPB after high-fat shake consumption
sCD14_3
sCD14 after high-fat shake consumption
ApoB48_4
ApoB48 after high-fat shake consumption
LPB_4
LPB after high-fat shake consumption
sCD14_4
sCD14 after high-fat shake consumption
ApoB48_5
ApoB48 after high-fat shake consumption
LPB_5
LPB after high-fat shake consumption
sCD14_5
sCD14 after high-fat shake consumption
Full Information
NCT ID
NCT05016596
First Posted
July 27, 2021
Last Updated
April 20, 2022
Sponsor
Wageningen University and Research
Collaborators
Ministry of Economic Affairs, Naturex SA, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Darling, Winclove Probiotics B.V., Bioiberica
1. Study Identification
Unique Protocol Identification Number
NCT05016596
Brief Title
Postprandial Lipids in IBS and Nutritional Treatment
Acronym
PLINT
Official Title
Postprandial Lipids in IBS and Nutritional Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University and Research
Collaborators
Ministry of Economic Affairs, Naturex SA, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Darling, Winclove Probiotics B.V., Bioiberica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Acacia gum
Arm Title
turmeric
Arm Type
Experimental
Arm Description
Turmeric supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
turmeric
Intervention Description
Turmeric supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
LPS_B
Description
LPS in venous blood samples collected at baseline
Time Frame
Baseline
Title
LBP_1
Description
LBP in venous blood samples collected after high-fat shake consumption.
Time Frame
1 hour post ingestion
Title
LPS_2
Description
LPS in venous blood samples collected after high-fat shake consumption.
Time Frame
2 hours post ingestion
Title
LPS_3
Description
LPS in venous blood samples collected after high-fat shake consumption.
Time Frame
3 hours post ingestion
Title
LPS_4
Description
LPS in venous blood samples collected after high-fat shake consumption.
Time Frame
4 hours post ingestion
Title
LPS_5
Description
LPS in venous blood samples collected after high-fat shake consumption.
Time Frame
5 hours post ingestion
Secondary Outcome Measure Information:
Title
ApoB48_B
Description
ApoB48 at baseline
Time Frame
Baseline
Title
LPB_B
Description
LPB at baseline
Time Frame
Baseline
Title
sCD14_B
Description
sCD14 at baseline
Time Frame
Baseline
Title
ApoB48_1
Description
ApoB48 after high-fat shake consumption
Time Frame
1 hour post ingestion
Title
LPB_1
Description
LPB after high-fat shake consumption
Time Frame
1 hour post ingestion
Title
sCD14_1
Description
sCD14 after high-fat shake consumption
Time Frame
1 hour post ingestion
Title
ApoB48_2
Description
ApoB48 after high-fat shake consumption
Time Frame
2 hours post ingestion
Title
LPB_2
Description
LPB after high-fat shake consumption
Time Frame
2 hours post ingestion
Title
sCD14_2
Description
sCD14 after high-fat shake consumption
Time Frame
2 hours post ingestion
Title
ApoB48_3
Description
ApoB48 after high-fat shake consumption
Time Frame
3 hours post ingestion
Title
LPB_3
Description
LPB after high-fat shake consumption
Time Frame
3 hours post ingestion
Title
sCD14_3
Description
sCD14 after high-fat shake consumption
Time Frame
3 hours post ingestion
Title
ApoB48_4
Description
ApoB48 after high-fat shake consumption
Time Frame
4 hours post ingestion
Title
LPB_4
Description
LPB after high-fat shake consumption
Time Frame
4 hours post ingestion
Title
sCD14_4
Description
sCD14 after high-fat shake consumption
Time Frame
4 hours post ingestion
Title
ApoB48_5
Description
ApoB48 after high-fat shake consumption
Time Frame
5 hours post ingestion
Title
LPB_5
Description
LPB after high-fat shake consumption
Time Frame
5 hours post ingestion
Title
sCD14_5
Description
sCD14 after high-fat shake consumption
Time Frame
5 hours post ingestion
Other Pre-specified Outcome Measures:
Title
Age
Description
Age
Time Frame
Baseline
Title
BMI
Description
BMI
Time Frame
Baseline
Title
Gender
Description
Gender
Time Frame
Baseline
Title
GI complaints
Description
GI complaints
Time Frame
Baseline
Title
IBS-related complaints (IBS-SSS)
Description
Severity of IBS-related complaints (IBS-SSS), single score
Time Frame
Baseline
Title
Stool frequency-3
Description
Stool frequency on test day -3
Time Frame
-72hr
Title
Stool frequency-2
Description
Stool frequency on test day -2
Time Frame
-48hr
Title
Stool frequency-1
Description
Stool frequency on test day -1
Time Frame
-24hr
Title
Stool frequency-T
Description
Stool frequency on test day
Time Frame
Testday (0hr)
Title
Stool frequency+1
Description
Stool frequency on test day +1
Time Frame
24hr
Title
Stool frequency+2
Description
Stool frequency on test day +2
Time Frame
48hr
Title
Stool consistency-3
Description
Stool consistency (Bristol stool chart) on test day -3
Time Frame
-72hr
Title
Stool consistency-2
Description
Stool consistency (Bristol stool chart) on test day -2
Time Frame
-48hr
Title
Stool consistency-1
Description
Stool consistency (Bristol stool chart) on test day -1
Time Frame
-24hr
Title
Stool consistency-T
Description
Stool consistency (Bristol stool chart) on test day
Time Frame
Testday (0hr)
Title
Stool consistency+1
Description
Stool consistency (Bristol stool chart) on test day +1
Time Frame
24hr
Title
Stool consistency+2
Description
Stool consistency (Bristol stool chart) on test day +2
Time Frame
48hr
Title
Abdominal pain-3
Description
Abdominal pain (Likert scale 0-10) on test day -3
Time Frame
-72hr
Title
Abdominal pain-2
Description
Abdominal pain (Likert scale 0-10) on test day -2
Time Frame
-48hr
Title
Abdominal pain-1
Description
Abdominal pain (Likert scale 0-10) on test day -1
Time Frame
-24hr
Title
Abdominal pain-T
Description
Abdominal pain (Likert scale 0-10) on test day
Time Frame
Testday (0hr)
Title
Abdominal pain+1
Description
Abdominal pain (Likert scale 0-10) on test day +1
Time Frame
24hr
Title
Abdominal pain+2
Description
Abdominal pain (Likert scale 0-10) on test day +2
Time Frame
48hr
Title
Bloating-3
Description
Bloating (Likert scale 0-10) on test day -3
Time Frame
-72hr
Title
Bloating-2
Description
Bloating (Likert scale 0-10) on test day -2
Time Frame
-48hr
Title
Bloating-1
Description
Bloating (Likert scale 0-10) on test day -1
Time Frame
-24hr
Title
Bloating-T
Description
Bloating (Likert scale 0-10) on test day
Time Frame
Testday (0hr)
Title
Bloating+1
Description
Bloating (Likert scale 0-10) on test day +1
Time Frame
24hr
Title
Bloating+2
Description
Bloating (Likert scale 0-10) on test day +2
Time Frame
48hr
Title
Flatulence-3
Description
Flatulence (Likert scale 0-10) on test day -3
Time Frame
-72hr
Title
Flatulence-2
Description
Flatulence (Likert scale 0-10) on test day -2
Time Frame
-48hr
Title
Flatulence-1
Description
Flatulence (Likert scale 0-10) on test day -1
Time Frame
-24hr
Title
Flatulence-T
Description
Flatulence (Likert scale 0-10) on test day
Time Frame
Testday (0hr)
Title
Flatulence+1
Description
Flatulence (Likert scale 0-10) on test day +1
Time Frame
24hr
Title
Flatulence+2
Description
Flatulence (Likert scale 0-10) on test day +2
Time Frame
48hr
Title
Nausea-3
Description
Nausea (Likert scale 0-10) on test day -3
Time Frame
-72hr
Title
Nausea-2
Description
Nausea (Likert scale 0-10) on test day -2
Time Frame
-48hr
Title
Nausea-1
Description
Nausea (Likert scale 0-10) on test day -1
Time Frame
-24hr
Title
Nausea-T
Description
Nausea (Likert scale 0-10) on test day
Time Frame
Testday (0hr)
Title
Nausea+1
Description
Nausea (Likert scale 0-10) on test day +1
Time Frame
24hr
Title
Nausea+2
Description
Nausea (Likert scale 0-10) on test day +2
Time Frame
48hr
Title
Heartburn-3
Description
Heartburn (Likert scale 0-10) on test day -3
Time Frame
-72hr
Title
Heartburn-2
Description
Heartburn (Likert scale 0-10) on test day -2
Time Frame
-48hr
Title
Heartburn-1
Description
Heartburn (Likert scale 0-10) on test day -1
Time Frame
-24hr
Title
Heartburn
Description
Heartburn (Likert scale 0-10) on test day
Time Frame
Testday (0hr)
Title
Heartburn+1
Description
Heartburn (Likert scale 0-10) on test day +1
Time Frame
24hr
Title
Heartburn+2
Description
Heartburn (Likert scale 0-10) on test day +2
Time Frame
48hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Wageningen University & Research
City
Wageningen
State/Province
Gelderland
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Postprandial Lipids in IBS and Nutritional Treatment
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