To investigate the effect of oral curcumin supplementation on different clinical parameters and the gut microbiota composition in patients with diabetes type II, inflammatory bowel disorders (both ulcerative colitis and Crohn*s disease in remission…
ID
Source
Brief title
Condition
- Diabetic complications
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Any 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
together with disease changes in SSCAI and HBI scores (ulcerative colitis and
Crohn*s disease) and changes in fecal calprotectin. Changes in the
inflammatory response will be assessed by measuring the changes in levels of
inflammatory markers (calprotectin, hemoglobin, hematocrit, MCV, Leucocytes,
thrombocytes, CRP, albumine, ironstatus (iron, ferritin, TYBC), bilirubin,
ASAT, ALAT, AF, y-GT, creatinine).
Secondary outcome
- Fecal gutmicrobiota composition (as determined by 16S sequencing) at three
timepoints being baseline, visit week 4 and visit week 8.
- changes in fecal SCFA metabolites at these three timepoints
- the fecal, urine and plasma (gutmicrobiota derived) curcumin metabolites at
these three timepoints
Background summary
Curcumin is an orange-yellow colored substance from the rhizomes of the herb
turmeric (Curcuma longa L.). Curcumin*s proposed antioxidant and
anti-inflammatory capacity are thought to explain its therapeutic action in the
prevention and treatment of various diseases. However, clinical studies did not
succeed to detect curcumin in human blood plasma due to its low bioavailability
and rapid metabolism. It has been established however that curcumin accumulates
in the small intestine of mice and rats. Furthermore, recent clinical studies
indicate that there is a potential role of curcumin in gut microbiota
composition of healthy subjects, patients with diabetes type II, Crohn*s
disease patients and ulcerative colitis patients. We aim to study the effect of
oral curcumin supplementation on the gut microbiota composition of these
patients.
Study objective
To investigate the effect of oral curcumin supplementation on different
clinical parameters and the gut microbiota composition in patients with
diabetes type II, inflammatory bowel disorders (both ulcerative colitis and
Crohn*s disease in remission) and healthy subjects and the effect
Study design
single-centre, open label study.
Intervention
3 gram oral curcumin twice a day over a period of 8 weeks. This will be
accompanied with a glucose sensor (Free Style Libre) two weeks before and last
two weeks of intervention for all patients groups. Fasting blood sampling and
fecal sampling will be obtained on t=-3 weeks, t=0 weeks, t=4 weeks and t=8
weeks. Patients will fill in an online dietary journal three days before
collection of fecal sample.
Study burden and risks
The burden of this study includes a screening visit, 3 visits on which subjects
will have to hand in fecal and urine samples and 4 overnight fasts. Venous
blood will be taken on all visits with a combined volume of 70 ml per
individual. Three days prior to the visit days subjects will be asked to record
daily dietary intake.
A dose up to 8 grams/day of curcumin is well tolerated in humans when taken
daily for 3 months (Hsieh, C.Y, et al., 2001). Mild gastrointestinal complains
were reported after a single dose of 10-12 grams of curcumin (Vareed, S.K, et
al., 2008). In this study a maximum dosage of 6 grams/day of curcumin extract
will be given. Mild to adverse effects are therefore expected.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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,
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS),
- Use of proton pump inhibitors (as this influences intestinal microbiota
composition)
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73225.018.20 |