Diabetes Mellitus Type 2, Crohn's disease, Colitis Ulcerosa and healthy volunteers
Conditions
Interventions
6 g Curcumin / day for 8 weeks
Sponsors
none
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes is to investigate changes in the composition of gut microbiota and the measurable outcomes of this change in composition. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Fecal gutmicrobiota composition (as determined by 16S sequencing) at these three timepoints - changes in fecal SCFA metabolites at these three timepoints - the fecal, urine and plasma (gutmicrobiota derived) curcumin metabolites at these three timepoints - 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 - disease changes in SSCAI and HBI scores (ulcerative colitis and Crohn’s disease) and changes in fecal calprotectin - 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) - Changes in enzymes involved in the inflammatory response such as inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2), lipoxygenase and xanthine oxidase activity) | — |
Contacts
Public ContactMaurice Kroon
Amsterdam UMC, location AMC
Outcome results
None listed