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Micellar Curcumin and Metabolic Syndrome Biomarkers

Primary Purpose

Metabolic Syndrome, Protection Against

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Micellar curcumin
Placebo
Sponsored by
University of Hohenheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome, Protection Against

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Biological Chemistry and Nutrition, University of Hohenheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Micellar curcumin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

C-reactive protein (CRP)
Serum CRP in mg/L

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2013
Last Updated
October 24, 2016
Sponsor
University of Hohenheim
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01925547
Brief Title
Micellar Curcumin and Metabolic Syndrome Biomarkers
Official Title
Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hohenheim
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Protection Against

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micellar curcumin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Micellar curcumin
Intervention Description
80 mg micellar curcumin (oral) three times a day for six weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.
Primary Outcome Measure Information:
Title
C-reactive protein (CRP)
Description
Serum CRP in mg/L
Time Frame
At baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Plasma curcumin concentrations
Description
Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma
Time Frame
At baseline and 6 weeks
Title
Serum alanine transaminase activity
Description
Serum activity of ALT in U/L
Time Frame
At baseline and 6 weeks
Title
Fasting blood glucose
Description
Fasting blood glucose in mmol/L
Time Frame
At baseline and 6 weeks
Title
Plasma tumor necrosis factor alpha
Description
Plasma concentrations of TNFα in pg/mL
Time Frame
At baseline and 6 weeks
Title
Serum uric acid
Description
Serum concentrations of uric acid in g/L
Time Frame
At baseline and 6 weeks
Title
Plasma albumin
Description
Plasma concentrations of albumin in g/L
Time Frame
At baseline and 6 weeks
Title
Serum total cholesterol
Description
Serum total cholesterol in mmol/L
Time Frame
At baseline and 6 weeks
Title
Serum triacylglycerols
Description
Serum triacylglycerols in mmol/L
Time Frame
At baseline and 6 weeks
Title
Serum HDL cholesterol
Description
Serum HDL cholesterol in mmol/L
Time Frame
At baseline and 6 weeks
Title
Serum LDL cholesterol
Description
Serum LDL cholesterol in mmol/L
Time Frame
At baseline and 6 weeks
Title
Serum aspartate transaminase activity
Description
Serum activity of AST in U/L
Time Frame
At baseline and 6 weeks
Title
Serum gamma glutamyl transferase activity
Description
Serum activity of gamma-GT in U/L
Time Frame
At baseline and 6 weeks
Title
Serum alkaline phosphatase activity
Description
Serum activity of ALP in U/L
Time Frame
At baseline and 6 weeks
Title
Serum bilirubin
Description
Serum concentrations of bilirubin in g/L
Time Frame
At baseline and 6 weeks
Title
Plasma interleukine 6
Description
Plasma concentrations of IL-6 in pg/mL
Time Frame
At baseline and 6 weeks
Title
Serum insulin
Description
Serum concentrations of insulin in pg/mL
Time Frame
At baseline and 6 weeks
Title
Body weight
Description
Body weight in kg
Time Frame
At baseline and 6 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure in mmHg
Time Frame
At baseline and 6 weeks
Title
Serum creatinine
Description
Serum concentrations of creatinine in g/L
Time Frame
At baseline and 6 weeks
Title
Systolic blood pressure
Description
Systolic blood pressure in mmHg
Time Frame
At baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Frank, Ph.D.
Organizational Affiliation
University of Hohenheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biological Chemistry and Nutrition, University of Hohenheim
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70599
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26909743
Citation
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.
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Micellar Curcumin and Metabolic Syndrome Biomarkers

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