Micellar Curcumin and Metabolic Syndrome Biomarkers
Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 25, 2016
October 1, 2016
8 months
July 23, 2013
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
C-reactive protein (CRP)
Serum CRP in mg/L
At baseline and 6 weeks
Secondary Outcomes (20)
Plasma curcumin concentrations
At baseline and 6 weeks
Serum alanine transaminase activity
At baseline and 6 weeks
Fasting blood glucose
At baseline and 6 weeks
Plasma tumor necrosis factor alpha
At baseline and 6 weeks
Serum uric acid
At baseline and 6 weeks
- +15 more secondary outcomes
Study Arms (2)
Micellar curcumin
EXPERIMENTALSubjects receive three times per day four capsules of curcumin micelles. One capsule contains 20 mg of curcumin. At the beginning, after three and six weeks of intake, blood samples are collected.
Placebo
PLACEBO COMPARATORSubjects receive three times per day four capsules of placebo preparation. At the beginning, after three and six weeks of intake, blood samples are collected.
Interventions
80 mg micellar curcumin (oral) three times a day for six weeks
Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.
Eligibility Criteria
You may qualify if:
- Total cholesterol \> 5.2 mmol/L
- LDL cholesterol \> 3.4 mmol/L
- Triglyceride \> 2.26 mmol/L
- CRP \> 2 mg/L
You may not qualify if:
- Intake of drugs or dietary supplements
- Pregnant women and breastfeeding mothers
- Smokers
- Previous illnesses such as heart attack, cancer or dementia
- Addiction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Biological Chemistry and Nutrition, University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599, Germany
Related Publications (1)
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.
PMID: 26909743RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Frank, Ph.D.
University of Hohenheim
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Ph.D.
Study Record Dates
First Submitted
July 23, 2013
First Posted
August 19, 2013
Study Start
July 1, 2013
Primary Completion
March 1, 2014
Study Completion
October 1, 2014
Last Updated
October 25, 2016
Record last verified: 2016-10