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Completed

NCT Number: NCT05016596

Postprandial Lipids in IBS and Nutritional Treatment

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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University & Research

Wageningen, Gelderland, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Turmeric

Dietary Supplement

Turmeric supplement

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. LPS_B

    Time frame: Baseline

    LPS in venous blood samples collected at baseline

  2. LBP_1

    Time frame: 1 hour post ingestion

    LBP in venous blood samples collected after high-fat shake consumption.

  3. LPS_2

    Time frame: 2 hours post ingestion

    LPS in venous blood samples collected after high-fat shake consumption.

  4. LPS_3

    Time frame: 3 hours post ingestion

    LPS in venous blood samples collected after high-fat shake consumption.

  5. LPS_4

    Time frame: 4 hours post ingestion

    LPS in venous blood samples collected after high-fat shake consumption.

  6. LPS_5

    Time frame: 5 hours post ingestion

    LPS in venous blood samples collected after high-fat shake consumption.

Secondary outcomes

  1. ApoB48_B

    Time frame: Baseline

    ApoB48 at baseline

  2. LPB_B

    Time frame: Baseline

    LPB at baseline

  3. sCD14_B

    Time frame: Baseline

    sCD14 at baseline

  4. ApoB48_1

    Time frame: 1 hour post ingestion

    ApoB48 after high-fat shake consumption

  5. LPB_1

    Time frame: 1 hour post ingestion

    LPB after high-fat shake consumption

  6. sCD14_1

    Time frame: 1 hour post ingestion

    sCD14 after high-fat shake consumption

  7. ApoB48_2

    Time frame: 2 hours post ingestion

    ApoB48 after high-fat shake consumption

  8. LPB_2

    Time frame: 2 hours post ingestion

    LPB after high-fat shake consumption

  9. sCD14_2

    Time frame: 2 hours post ingestion

    sCD14 after high-fat shake consumption

  10. ApoB48_3

    Time frame: 3 hours post ingestion

    ApoB48 after high-fat shake consumption

  11. LPB_3

    Time frame: 3 hours post ingestion

    LPB after high-fat shake consumption

  12. sCD14_3

    Time frame: 3 hours post ingestion

    sCD14 after high-fat shake consumption

  13. ApoB48_4

    Time frame: 4 hours post ingestion

    ApoB48 after high-fat shake consumption

  14. LPB_4

    Time frame: 4 hours post ingestion

    LPB after high-fat shake consumption

  15. sCD14_4

    Time frame: 4 hours post ingestion

    sCD14 after high-fat shake consumption

  16. ApoB48_5

    Time frame: 5 hours post ingestion

    ApoB48 after high-fat shake consumption

  17. LPB_5

    Time frame: 5 hours post ingestion

    LPB after high-fat shake consumption

  18. sCD14_5

    Time frame: 5 hours post ingestion

    sCD14 after high-fat shake consumption

Other outcomes

  1. Age

    Time frame: Baseline

    Age

  2. BMI

    Time frame: Baseline

    BMI

  3. Gender

    Time frame: Baseline

    Gender

  4. GI complaints

    Time frame: Baseline

    GI complaints

  5. IBS-related complaints (IBS-SSS)

    Time frame: Baseline

    Severity of IBS-related complaints (IBS-SSS), single score

  6. Stool frequency-3

    Time frame: -72hr

    Stool frequency on test day -3

  7. Stool frequency-2

    Time frame: -48hr

    Stool frequency on test day -2

  8. Stool frequency-1

    Time frame: -24hr

    Stool frequency on test day -1

  9. Stool frequency-T

    Time frame: Testday (0hr)

    Stool frequency on test day

  10. Stool frequency+1

    Time frame: 24hr

    Stool frequency on test day +1

  11. Stool frequency+2

    Time frame: 48hr

    Stool frequency on test day +2

  12. Stool consistency-3

    Time frame: -72hr

    Stool consistency (Bristol stool chart) on test day -3

  13. Stool consistency-2

    Time frame: -48hr

    Stool consistency (Bristol stool chart) on test day -2

  14. Stool consistency-1

    Time frame: -24hr

    Stool consistency (Bristol stool chart) on test day -1

  15. Stool consistency-T

    Time frame: Testday (0hr)

    Stool consistency (Bristol stool chart) on test day

  16. Stool consistency+1

    Time frame: 24hr

    Stool consistency (Bristol stool chart) on test day +1

  17. Stool consistency+2

    Time frame: 48hr

    Stool consistency (Bristol stool chart) on test day +2

  18. Abdominal pain-3

    Time frame: -72hr

    Abdominal pain (Likert scale 0-10) on test day -3

  19. Abdominal pain-2

    Time frame: -48hr

    Abdominal pain (Likert scale 0-10) on test day -2

  20. Abdominal pain-1

    Time frame: -24hr

    Abdominal pain (Likert scale 0-10) on test day -1

  21. Abdominal pain-T

    Time frame: Testday (0hr)

    Abdominal pain (Likert scale 0-10) on test day

  22. Abdominal pain+1

    Time frame: 24hr

    Abdominal pain (Likert scale 0-10) on test day +1

  23. Abdominal pain+2

    Time frame: 48hr

    Abdominal pain (Likert scale 0-10) on test day +2

  24. Bloating-3

    Time frame: -72hr

    Bloating (Likert scale 0-10) on test day -3

  25. Bloating-2

    Time frame: -48hr

    Bloating (Likert scale 0-10) on test day -2

  26. Bloating-1

    Time frame: -24hr

    Bloating (Likert scale 0-10) on test day -1

  27. Bloating-T

    Time frame: Testday (0hr)

    Bloating (Likert scale 0-10) on test day

  28. Bloating+1

    Time frame: 24hr

    Bloating (Likert scale 0-10) on test day +1

  29. Bloating+2

    Time frame: 48hr

    Bloating (Likert scale 0-10) on test day +2

  30. Flatulence-3

    Time frame: -72hr

    Flatulence (Likert scale 0-10) on test day -3

  31. Flatulence-2

    Time frame: -48hr

    Flatulence (Likert scale 0-10) on test day -2

  32. Flatulence-1

    Time frame: -24hr

    Flatulence (Likert scale 0-10) on test day -1

  33. Flatulence-T

    Time frame: Testday (0hr)

    Flatulence (Likert scale 0-10) on test day

  34. Flatulence+1

    Time frame: 24hr

    Flatulence (Likert scale 0-10) on test day +1

  35. Flatulence+2

    Time frame: 48hr

    Flatulence (Likert scale 0-10) on test day +2

  36. Nausea-3

    Time frame: -72hr

    Nausea (Likert scale 0-10) on test day -3

  37. Nausea-2

    Time frame: -48hr

    Nausea (Likert scale 0-10) on test day -2

  38. Nausea-1

    Time frame: -24hr

    Nausea (Likert scale 0-10) on test day -1

  39. Nausea-T

    Time frame: Testday (0hr)

    Nausea (Likert scale 0-10) on test day

  40. Nausea+1

    Time frame: 24hr

    Nausea (Likert scale 0-10) on test day +1

  41. Nausea+2

    Time frame: 48hr

    Nausea (Likert scale 0-10) on test day +2

  42. Heartburn-3

    Time frame: -72hr

    Heartburn (Likert scale 0-10) on test day -3

  43. Heartburn-2

    Time frame: -48hr

    Heartburn (Likert scale 0-10) on test day -2

  44. Heartburn-1

    Time frame: -24hr

    Heartburn (Likert scale 0-10) on test day -1

  45. Heartburn

    Time frame: Testday (0hr)

    Heartburn (Likert scale 0-10) on test day

  46. Heartburn+1

    Time frame: 24hr

    Heartburn (Likert scale 0-10) on test day +1

  47. Heartburn+2

    Time frame: 48hr

    Heartburn (Likert scale 0-10) on test day +2

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • Bioiberica
  • Darling
  • Givaudan France Naturals
  • Ingredia S.A.
  • Ingredion Incorporated
  • Ministry of Economic Affairs
  • Nexira
  • Roquette Freres
  • Wecare
  • Winclove Probiotics B.V.

Registry information

Acronym: PLINT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2021
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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