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Postprandial Lipids in IBS and Nutritional Treatment

Postprandial Lipids in IBS and Nutritional Treatment - PLINT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50848
Enrollment
20
Registered
2021-06-22
Start date
2021-11-15
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome spastic colon

Interventions

Three times a single dose (300mg) of Turmipure GOLD® and placebo.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary study parameter is blood LPS levels.

Secondary

MeasureTime frame
The secondary study parameters are gastrointestinal complaints, and blood levels of LPS-related biomarkers.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)