Clinical trial NCT01925547: Micellar Curcumin and Metabolic Syndrome Biomarkers
Official title: Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome, Protection Against
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-08-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of micellar curcumin on inflammation and lipid metabolism markers in subjects at risk for the metabolic syndrome.


Eligibility criteria: Inclusion criteria:

* Total cholesterol \> 5.2 mmol/L
* LDL cholesterol \> 3.4 mmol/L
* Triglyceride \> 2.26 mmol/L
* CRP \> 2 mg/L

Exclusion criteria:

* Intake of drugs or dietary supplements
* Pregnant women and breastfeeding mothers
* Smokers
* Previous illnesses such as heart attack, cancer or dementia
* Addiction

Primary outcomes:
measure: C-reactive protein (CRP)
timeFrame: At baseline and 6 weeks
Secondary outcomes:
measure: Plasma curcumin concentrations
timeFrame: At baseline and 6 weeks
measure: Serum alanine transaminase activity
timeFrame: At baseline and 6 weeks
measure: Fasting blood glucose
timeFrame: At baseline and 6 weeks
measure: Plasma tumor necrosis factor alpha
timeFrame: At baseline and 6 weeks
measure: Serum uric acid
timeFrame: At baseline and 6 weeks
measure: Plasma albumin
timeFrame: At baseline and 6 weeks
measure: Serum total cholesterol
timeFrame: At baseline and 6 weeks
measure: Serum triacylglycerols
timeFrame: At baseline and 6 weeks
measure: Serum HDL cholesterol
timeFrame: At baseline and 6 weeks
measure: Serum LDL cholesterol
timeFrame: At baseline and 6 weeks
measure: Serum aspartate transaminase activity
timeFrame: At baseline and 6 weeks
measure: Serum gamma glutamyl transferase activity
timeFrame: At baseline and 6 weeks
measure: Serum alkaline phosphatase activity
timeFrame: At baseline and 6 weeks
measure: Serum bilirubin
timeFrame: At baseline and 6 weeks
measure: Plasma interleukine 6
timeFrame: At baseline and 6 weeks
measure: Serum insulin
timeFrame: At baseline and 6 weeks
measure: Body weight
timeFrame: At baseline and 6 weeks
measure: Diastolic blood pressure
timeFrame: At baseline and 6 weeks
measure: Serum creatinine
timeFrame: At baseline and 6 weeks
measure: Systolic blood pressure
timeFrame: At baseline and 6 weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Biological Chemistry and Nutrition, University of Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Jan Frank, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kocher A, Bohnert L, Schiborr C, Frank J. Highly bioavailable micellar curcuminoids accumulate in blood, are safe and do not reduce blood lipids and inflammation markers in moderately hyperlipidemic individuals. Mol Nutr Food Res. 2016 Jul;60(7):1555-63. doi: 10.1002/mnfr.201501034. Epub 2016 May 23.