Metabolic Syndrome, Protection Against
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMicellar curcumin
80 mg micellar curcumin (oral) three times a day for six weeks
DIETARY_SUPPLEMENTPlacebo
Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.
Sponsors
German Federal Ministry of Education and Research
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | At baseline and 6 weeks | Serum CRP in mg/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma curcumin concentrations | At baseline and 6 weeks | Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma |
| Serum alanine transaminase activity | At baseline and 6 weeks | Serum activity of ALT in U/L |
| Fasting blood glucose | At baseline and 6 weeks | Fasting blood glucose in mmol/L |
| Plasma tumor necrosis factor alpha | At baseline and 6 weeks | Plasma concentrations of TNFα in pg/mL |
| Serum uric acid | At baseline and 6 weeks | Serum concentrations of uric acid in g/L |
| Plasma albumin | At baseline and 6 weeks | Plasma concentrations of albumin in g/L |
| Serum total cholesterol | At baseline and 6 weeks | Serum total cholesterol in mmol/L |
| Serum triacylglycerols | At baseline and 6 weeks | Serum triacylglycerols in mmol/L |
| Serum HDL cholesterol | At baseline and 6 weeks | Serum HDL cholesterol in mmol/L |
| Serum LDL cholesterol | At baseline and 6 weeks | Serum LDL cholesterol in mmol/L |
| Serum aspartate transaminase activity | At baseline and 6 weeks | Serum activity of AST in U/L |
| Serum gamma glutamyl transferase activity | At baseline and 6 weeks | Serum activity of gamma-GT in U/L |
| Serum alkaline phosphatase activity | At baseline and 6 weeks | Serum activity of ALP in U/L |
| Serum bilirubin | At baseline and 6 weeks | Serum concentrations of bilirubin in g/L |
| Plasma interleukine 6 | At baseline and 6 weeks | Plasma concentrations of IL-6 in pg/mL |
| Serum insulin | At baseline and 6 weeks | Serum concentrations of insulin in pg/mL |
| Body weight | At baseline and 6 weeks | Body weight in kg |
| Diastolic blood pressure | At baseline and 6 weeks | Diastolic blood pressure in mmHg |
| Serum creatinine | At baseline and 6 weeks | Serum concentrations of creatinine in g/L |
| Systolic blood pressure | At baseline and 6 weeks | Systolic blood pressure in mmHg |
Countries
Germany
Outcome results
None listed