IBS - Irritable Bowel SyndromePLINTNCT05016596

Postprandial Lipids in IBS and Nutritional Treatment

A study testing turmeric in people with IBS - Irritable Bowel Syndrome, run by Wageningen University and Research at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: IBS - Irritable Bowel Syndrome
What is being tested?: turmeric
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteNetherlands
Study dates: 15 Nov 2021to 11 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Wageningen University & Research
Wageningen, Gelderland

Other trials in Netherlands

About this study

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.

Conditions: IBS - Irritable Bowel Syndrome
Being tested: turmeric, placebo
Medical subject headings: Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

turmericDietary supplement
Turmeric supplement
placeboDietary supplement
Placebo

Study groups in NCT05016596
Study group	Role	What they receive
placebo	Placebo comparator	Acacia gum Receives: Dietary Supplement: placebo
turmeric	Experimental	Turmeric supplement Receives: Dietary Supplement: turmeric

What is being measured

The primary outcome is the main question the study is designed to answer.

LPS_B
LPS in venous blood samples collected at baseline
Measured: Baseline
LBP_1
LBP in venous blood samples collected after high-fat shake consumption.
Measured: 1 hour post ingestion
LPS_2
LPS in venous blood samples collected after high-fat shake consumption.
Measured: 2 hours post ingestion
LPS_3
LPS in venous blood samples collected after high-fat shake consumption.
Measured: 3 hours post ingestion
LPS_4
LPS in venous blood samples collected after high-fat shake consumption.
Measured: 4 hours post ingestion
LPS_5
LPS in venous blood samples collected after high-fat shake consumption.
Measured: 5 hours post ingestion

Secondary outcomes (18)

ApoB48_B
ApoB48 at baseline
Measured: Baseline
LPB_B
LPB at baseline
Measured: Baseline
sCD14_B
sCD14 at baseline
Measured: Baseline
ApoB48_1
ApoB48 after high-fat shake consumption
Measured: 1 hour post ingestion
LPB_1
LPB after high-fat shake consumption
Measured: 1 hour post ingestion
sCD14_1
sCD14 after high-fat shake consumption
Measured: 1 hour post ingestion
ApoB48_2
ApoB48 after high-fat shake consumption
Measured: 2 hours post ingestion
LPB_2
LPB after high-fat shake consumption
Measured: 2 hours post ingestion
sCD14_2
sCD14 after high-fat shake consumption
Measured: 2 hours post ingestion
ApoB48_3
ApoB48 after high-fat shake consumption
Measured: 3 hours post ingestion
LPB_3
LPB after high-fat shake consumption
Measured: 3 hours post ingestion
sCD14_3
sCD14 after high-fat shake consumption
Measured: 3 hours post ingestion
ApoB48_4
ApoB48 after high-fat shake consumption
Measured: 4 hours post ingestion
LPB_4
LPB after high-fat shake consumption
Measured: 4 hours post ingestion
sCD14_4
sCD14 after high-fat shake consumption
Measured: 4 hours post ingestion
ApoB48_5
ApoB48 after high-fat shake consumption
Measured: 5 hours post ingestion
LPB_5
LPB after high-fat shake consumption
Measured: 5 hours post ingestion
sCD14_5
sCD14 after high-fat shake consumption
Measured: 5 hours post ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202111 Apr 2022

First posted23 Aug 2021
Study start15 Nov 2021
Primary completion11 Apr 2022
Study completion11 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05016596
Sponsor's protocol ID: NL75915.041.21
Acronym: PLINT
Status last verified: Apr 2022
First submitted: 27 Jul 2021
Last updated: 21 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

All IBS - Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postprandial Lipids in IBS and Nutritional Treatment
ClinicalTrials.gov ID: NCT05016596
Acronym / sponsor ID: PLINT / NL75915.041.21
Conditions: IBS - Irritable Bowel Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Wageningen University and ResearchUniversity, hospital or other
Collaborators: Ministry of Economic Affairs, Givaudan France Naturals, Nexira, Wecare, Roquette Freres, Ingredion Incorporated, Ingredia S.A., Darling, Winclove Probiotics B.V., Bioiberica
Study start: 15 Nov 2021 (actual)
Primary completion: 11 Apr 2022 (actual)
Study completion: 11 Apr 2022 (actual)
First posted: 23 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In this double-blind, randomized, placebo-controlled cross-over trial 20 adult (18-70 yrs) IBS-D patients will be included.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
placebo	Placebo comparator	Dietary Supplement: placeboAcacia gum
turmeric	Experimental	Dietary Supplement: turmericTurmeric supplement

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
turmericTurmeric supplement	Dietary supplement	turmeric
placeboPlacebo	Dietary supplement	placebo

Primary outcome

LPS_B
Time frame: Baseline
LPS in venous blood samples collected at baseline
LBP_1
Time frame: 1 hour post ingestion
LBP in venous blood samples collected after high-fat shake consumption.
LPS_2
Time frame: 2 hours post ingestion
LPS in venous blood samples collected after high-fat shake consumption.
LPS_3
Time frame: 3 hours post ingestion
LPS in venous blood samples collected after high-fat shake consumption.
LPS_4
Time frame: 4 hours post ingestion
LPS in venous blood samples collected after high-fat shake consumption.
LPS_5
Time frame: 5 hours post ingestion
LPS in venous blood samples collected after high-fat shake consumption.

18 secondary outcomes

ApoB48_B
Time frame: Baseline
LPB_B
Time frame: Baseline
sCD14_B
Time frame: Baseline
ApoB48_1
Time frame: 1 hour post ingestion
LPB_1
Time frame: 1 hour post ingestion
sCD14_1
Time frame: 1 hour post ingestion
ApoB48_2
Time frame: 2 hours post ingestion
LPB_2
Time frame: 2 hours post ingestion
sCD14_2
Time frame: 2 hours post ingestion
ApoB48_3
Time frame: 3 hours post ingestion
LPB_3
Time frame: 3 hours post ingestion
sCD14_3
Time frame: 3 hours post ingestion
ApoB48_4
Time frame: 4 hours post ingestion
LPB_4
Time frame: 4 hours post ingestion
sCD14_4
Time frame: 4 hours post ingestion
ApoB48_5
Time frame: 5 hours post ingestion
LPB_5
Time frame: 5 hours post ingestion
sCD14_5
Time frame: 5 hours post ingestion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Individual participant dataSharing planned: No

Related trials for IBS - Irritable Bowel Syndrome

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing turmeric in people with IBS - Irritable Bowel Syndrome, run by Wageningen University and Research at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LPS_B (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05016596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.