Micellar Curcumin and Metabolic Syndrome Biomarkers

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers

Conditions
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Metabolic Syndrome, Protection Against

Intervention / Treatment
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* Dietary Supplement: Micellar curcumin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micellar curcumin<br>Subjects 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. | Dietary Supplement: Micellar curcumin<br>* 80 mg micellar curcumin (oral) three times a day for six weeks<br>|
| Placebo Comparator: Placebo<br>Subjects receive three times per day four capsules of placebo preparation. At the beginning, after three and six weeks of intake, blood samples are collected. | Dietary Supplement: Placebo<br>* Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CRP) | Serum CRP in mg/L | At baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma curcumin concentrations | Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma | At baseline and 6 weeks | 
| Serum alanine transaminase activity | Serum activity of ALT in U/L | At baseline and 6 weeks | 
| Fasting blood glucose | Fasting blood glucose in mmol/L | At baseline and 6 weeks | 
| Plasma tumor necrosis factor alpha | Plasma concentrations of TNFα in pg/mL | At baseline and 6 weeks | 
| Serum uric acid | Serum concentrations of uric acid in g/L | At baseline and 6 weeks | 
| Plasma albumin | Plasma concentrations of albumin in g/L | At baseline and 6 weeks | 
| Serum total cholesterol | Serum total cholesterol in mmol/L | At baseline and 6 weeks | 
| Serum triacylglycerols | Serum triacylglycerols in mmol/L | At baseline and 6 weeks | 
| Serum HDL cholesterol | Serum HDL cholesterol in mmol/L | At baseline and 6 weeks | 
| Serum LDL cholesterol | Serum LDL cholesterol in mmol/L | At baseline and 6 weeks | 
| Serum aspartate transaminase activity | Serum activity of AST in U/L | At baseline and 6 weeks | 
| Serum gamma glutamyl transferase activity | Serum activity of gamma-GT in U/L | At baseline and 6 weeks | 
| Serum alkaline phosphatase activity | Serum activity of ALP in U/L | At baseline and 6 weeks | 
| Serum bilirubin | Serum concentrations of bilirubin in g/L | At baseline and 6 weeks | 
| Plasma interleukine 6 | Plasma concentrations of IL-6 in pg/mL | At baseline and 6 weeks | 
| Serum insulin | Serum concentrations of insulin in pg/mL | At baseline and 6 weeks | 
| Body weight | Body weight in kg | At baseline and 6 weeks | 
| Diastolic blood pressure | Diastolic blood pressure in mmHg | At baseline and 6 weeks | 
| Serum creatinine | Serum concentrations of creatinine in g/L | At baseline and 6 weeks | 
| Systolic blood pressure | Systolic blood pressure in mmHg | At baseline and 6 weeks |