The primary objective of this study is to determine the effect of short-term Turmipure GOLD® supplementation on LPS translocation in IBS-D and IBS-M patients after a high-fat challenge.The secondary objective of this study is to determine the effect…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is blood LPS levels.
Secondary outcome
The secondary study parameters are gastrointestinal complaints, and blood
levels of LPS-related biomarkers.
Background 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, we selected a turmeric supplement for
in vivo validation of their potential beneficial effects on fat-induced
intestinal barrier disruption as measured with LPS translocation in IBS
patients with diarrhea.
Study objective
The primary objective of this study is to determine the effect of short-term
Turmipure GOLD® supplementation on LPS translocation in IBS-D and IBS-M
patients after a high-fat challenge.
The secondary objective of this study is to determine the effect of short-term
Turmipure GOLD® supplementation on gastrointestinal complaints and LPS-related
biomarkers in IBS-D and IBS-M patients after a high-fat challenge.
Study design
A double-blind, randomized, placebo-controlled cross-over trial.
Intervention
Three times a single dose (300mg) of Turmipure GOLD® and placebo.
Study burden and risks
Study participants have to invest about 16 hours of their time in this study.
They will visit the research facility three times. On six occasions they have
to consume one supplement or placebo capsule. 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 (total
amount collected = 132mL divided over two test days) and is therefore within
acceptable limits.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
-IBS patients that meet the Rome IV criteria + additional criteria specific for
the diarrhea-predominant and mixed subtype: IBS-D and IBS-M
- 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. Some supplements are allowed (judged by medical
supervisor MD Ben Witteman) but intake should be kept stable during the whole
study period.
* 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75915.041.21 |
| Other | volgt nog |