Effect of oral Curcumin on Gut Microbiota Composition in patients with Diabetes Type II, Ulcerative Colitis, Crohn's disease and healthy subjects

Not yet recruiting

Conditions: Diabetes Mellitus Type 2, Crohn's disease, Colitis Ulcerosa and healthy volunteers

Registration Number: NL-OMON26278

Lead Sponsor: none

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Aged 18-65 years
- Stable therapy (i.e. no major dosage changes in the last three months)
- Able to give written informed consent

Exclusion Criteria

- Tobacco use (as there are indications this influences the gut microbiota, Huang et al. 2019)
- Alcohol use > 1 units/day,
- Excessive weight loss of >10% in the last 3 months,
- Levels of plasma aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) 2.5 times or more the upper limit of the normal range,
- Other liver abnormalities,
- Known intolerance to curcumin or curcumin-derivatives,
- Use of food supplements containing curcumin or/and black pepper for at least 3 days prior to each study day and two weeks prior to the study,
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS),
- Use of proton pump inhibitors (as this influences intestinal microbiota composition)
- Eating/drinking of grapefruit and grapefruit-containing products or star fruit during the course of the study,
- Incomplete information or unwillingness to comply with the intervention,
- Participation in other intervention studies 3 months before or after the duration of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes is to investigate changes in the composition of gut microbiota and the measurable outcomes of this change in composition.

Secondary Outcome Measures

Name	Time	Method
- Fecal gutmicrobiota composition (as determined by 16S sequencing) at these three timepoints<br>- changes in fecal SCFA metabolites at these three timepoints<br>- the fecal, urine and plasma (gutmicrobiota derived) curcumin metabolites at these three timepoints<br>- changes in Continuous Glucose Monitoring (CGM, Free Style Libre) before and at end of study. Also, fasting glucose, insulin levels, HOMA, Hba1c, lipid profile including LDL-cholesterol (diabetes type II patients) will be studied<br>- disease changes in SSCAI and HBI scores (ulcerative colitis and Crohn’s disease) and changes in fecal calprotectin<br>- Changes in the inflammatory response by assessing the changes in levels of inflammatory markers (IL-1,-2,-6,-8 and -12, tumor necrosis factor-alpha (TNF-a), monocyte chemoattractant protein-1, LPS binding protein (LPB)<br>- Changes in enzymes involved in the inflammatory response such as inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2), lipoxygenase and xanthine oxidase activity)