Micellar Curcumin and Metabolic Syndrome Biomarkers

• Sponsor: University of Hohenheim (Other)
• Overall Status: Completed
• CT.gov ID: NCT01925547
• Collaborator: German Federal Ministry of Education and Research (Other)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome, Protection Against	Dietary Supplement: Micellar curcumin; Dietary Supplement: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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; 80 mg micellar curcumin (oral) three times a day for six weeks
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; Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.

Outcome Measures

Primary Outcome Measures

1. C-reactive protein (CRP) [At baseline and 6 weeks]

   Serum CRP in mg/L

Secondary Outcome Measures

1. Plasma curcumin concentrations [At baseline and 6 weeks]

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

2. Serum alanine transaminase activity [At baseline and 6 weeks]

   Serum activity of ALT in U/L

3. Fasting blood glucose [At baseline and 6 weeks]

   Fasting blood glucose in mmol/L

4. Plasma tumor necrosis factor alpha [At baseline and 6 weeks]

   Plasma concentrations of TNFα in pg/mL

5. Serum uric acid [At baseline and 6 weeks]

   Serum concentrations of uric acid in g/L

6. Plasma albumin [At baseline and 6 weeks]

   Plasma concentrations of albumin in g/L

7. Serum total cholesterol [At baseline and 6 weeks]

   Serum total cholesterol in mmol/L

8. Serum triacylglycerols [At baseline and 6 weeks]

   Serum triacylglycerols in mmol/L

9. Serum HDL cholesterol [At baseline and 6 weeks]

   Serum HDL cholesterol in mmol/L

10. Serum LDL cholesterol [At baseline and 6 weeks]

    Serum LDL cholesterol in mmol/L

11. Serum aspartate transaminase activity [At baseline and 6 weeks]

    Serum activity of AST in U/L

12. Serum gamma glutamyl transferase activity [At baseline and 6 weeks]

    Serum activity of gamma-GT in U/L

13. Serum alkaline phosphatase activity [At baseline and 6 weeks]

    Serum activity of ALP in U/L

14. Serum bilirubin [At baseline and 6 weeks]

    Serum concentrations of bilirubin in g/L

15. Plasma interleukine 6 [At baseline and 6 weeks]

    Plasma concentrations of IL-6 in pg/mL

16. Serum insulin [At baseline and 6 weeks]

    Serum concentrations of insulin in pg/mL

17. Body weight [At baseline and 6 weeks]

    Body weight in kg

18. Diastolic blood pressure [At baseline and 6 weeks]

    Diastolic blood pressure in mmHg

19. Serum creatinine [At baseline and 6 weeks]

    Serum concentrations of creatinine in g/L

20. Systolic blood pressure [At baseline and 6 weeks]

    Systolic blood pressure in mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• Intake of drugs or dietary supplements

• Pregnant women and breastfeeding mothers

• Smokers

• Previous illnesses such as heart attack, cancer or dementia

• Addiction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Biological Chemistry and Nutrition, University of Hohenheim	Stuttgart	Baden-Württemberg	Germany	70599

Sponsors and Collaborators

• University of Hohenheim
• German Federal Ministry of Education and Research

Investigators

• Principal Investigator: Jan Frank, Ph.D., University of Hohenheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Frank, Professor, Ph.D., University of Hohenheim
• ClinicalTrials.gov Identifier: NCT01925547
• Other Study ID Numbers: 0315679-HS3
• First Posted: Aug 19, 2013
• Last Update Posted: Oct 25, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Curcumin

Study Results

No Results Posted as of Oct 25, 2016