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CompletedNCT01925547Updated Oct 25, 2016

Micellar Curcumin and Metabolic Syndrome Biomarkers

A Phase 2 interventional study of Micellar curcumin and Placebo in Metabolic Syndrome, Protection Against, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-25.

Sponsored by University of Hohenheim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metabolic Syndrome, Protection Against
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Hohenheim is the lead sponsor of 42 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion criteria:

  • Intake of drugs or dietary supplements
  • Pregnant women and breastfeeding mothers
  • Smokers
  • Previous illnesses such as heart attack, cancer or dementia
  • Addiction
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Micellar curcumin

    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

  • Placebo comparator
    Placebo

    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

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.

06

What researchers measure

Primary outcomes

  1. C-reactive protein (CRP)

    Serum CRP in mg/L

    Time frame: At baseline and 6 weeks

Secondary outcomes

  1. Plasma curcumin concentrations

    Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma

    Time frame: At baseline and 6 weeks

  2. Serum alanine transaminase activity

    Serum activity of ALT in U/L

    Time frame: At baseline and 6 weeks

  3. Fasting blood glucose

    Fasting blood glucose in mmol/L

    Time frame: At baseline and 6 weeks

  4. Plasma tumor necrosis factor alpha

    Plasma concentrations of TNFα in pg/mL

    Time frame: At baseline and 6 weeks

  5. Serum uric acid

    Serum concentrations of uric acid in g/L

    Time frame: At baseline and 6 weeks

  6. Plasma albumin

    Plasma concentrations of albumin in g/L

    Time frame: At baseline and 6 weeks

  7. Serum total cholesterol

    Serum total cholesterol in mmol/L

    Time frame: At baseline and 6 weeks

  8. Serum triacylglycerols

    Serum triacylglycerols in mmol/L

    Time frame: At baseline and 6 weeks

  9. Serum HDL cholesterol

    Serum HDL cholesterol in mmol/L

    Time frame: At baseline and 6 weeks

  10. Serum LDL cholesterol

    Serum LDL cholesterol in mmol/L

    Time frame: At baseline and 6 weeks

  11. Serum aspartate transaminase activity

    Serum activity of AST in U/L

    Time frame: At baseline and 6 weeks

  12. Serum gamma glutamyl transferase activity

    Serum activity of gamma-GT in U/L

    Time frame: At baseline and 6 weeks

  13. Serum alkaline phosphatase activity

    Serum activity of ALP in U/L

    Time frame: At baseline and 6 weeks

  14. Serum bilirubin

    Serum concentrations of bilirubin in g/L

    Time frame: At baseline and 6 weeks

  15. Plasma interleukine 6

    Plasma concentrations of IL-6 in pg/mL

    Time frame: At baseline and 6 weeks

  16. Serum insulin

    Serum concentrations of insulin in pg/mL

    Time frame: At baseline and 6 weeks

  17. Body weight

    Body weight in kg

    Time frame: At baseline and 6 weeks

  18. Diastolic blood pressure

    Diastolic blood pressure in mmHg

    Time frame: At baseline and 6 weeks

  19. Serum creatinine

    Serum concentrations of creatinine in g/L

    Time frame: At baseline and 6 weeks

  20. Systolic blood pressure

    Systolic blood pressure in mmHg

    Time frame: At baseline and 6 weeks

07

Study locations

1 site
  • Institute of Biological Chemistry and Nutrition, University of Hohenheim
    Stuttgart, Baden-Württemberg 70599, Germany
08

References and documents

Publications

  • 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. PubMed 26909743 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01925547
Lead sponsor
University of Hohenheim
Collaborators
German Federal Ministry of Education and Research
Responsible party
Jan Frank (Professor, Ph.D., University of Hohenheim) — Principal investigator
First posted
Aug 19, 2013
Start date
Jul 2013
Primary completion
Mar 2014
Completion
Oct 2014
Last update
Oct 25, 2016

Study contacts

Jan Frank, Ph.D.
principal investigator · University of Hohenheim

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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