Metabolic Syndrome, Protection AgainstPhase 2NCT01925547
Micellar Curcumin and Metabolic Syndrome Biomarkers
A Phase 2 study testing Micellar curcumin in people with Metabolic Syndrome, Protection Against, run by University of Hohenheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Protection Against
- What is being tested?
- Micellar curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total cholesterol > 5.2 mmol/L
- LDL cholesterol > 3.4 mmol/L
- Triglyceride > 2.26 mmol/L
- CRP > 2 mg/L
Who cannot join
- Intake of drugs or dietary supplements
- Pregnant women and breastfeeding mothers
- Smokers
- Previous illnesses such as heart attack, cancer or dementia
- Addiction
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Biological Chemistry and Nutrition, University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
About this study
Official title: Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
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.
- Conditions
- Metabolic Syndrome, Protection Against
- Being tested
- Micellar curcumin, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micellar curcuminDietary supplement
80 mg micellar curcumin (oral) three times a day for six weeks
PlaceboDietary supplement
Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Micellar curcumin | Experimental | 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. Receives: Dietary Supplement: Micellar curcumin |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP)
Serum CRP in mg/L
Measured: At baseline and 6 weeks
Secondary outcomes (20)
Plasma curcumin concentrations
Concentrations (in nmol/L) of curcumin and curcumin conjugates in plasma
Measured: At baseline and 6 weeks
Serum alanine transaminase activity
Serum activity of ALT in U/L
Measured: At baseline and 6 weeks
Fasting blood glucose
Fasting blood glucose in mmol/L
Measured: At baseline and 6 weeks
Plasma tumor necrosis factor alpha
Plasma concentrations of TNFα in pg/mL
Measured: At baseline and 6 weeks
Serum uric acid
Serum concentrations of uric acid in g/L
Measured: At baseline and 6 weeks
Plasma albumin
Plasma concentrations of albumin in g/L
Measured: At baseline and 6 weeks
Serum total cholesterol
Serum total cholesterol in mmol/L
Measured: At baseline and 6 weeks
Serum triacylglycerols
Serum triacylglycerols in mmol/L
Measured: At baseline and 6 weeks
Serum HDL cholesterol
Serum HDL cholesterol in mmol/L
Measured: At baseline and 6 weeks
Serum LDL cholesterol
Serum LDL cholesterol in mmol/L
Measured: At baseline and 6 weeks
Serum aspartate transaminase activity
Serum activity of AST in U/L
Measured: At baseline and 6 weeks
Serum gamma glutamyl transferase activity
Serum activity of gamma-GT in U/L
Measured: At baseline and 6 weeks
Serum alkaline phosphatase activity
Serum activity of ALP in U/L
Measured: At baseline and 6 weeks
Serum bilirubin
Serum concentrations of bilirubin in g/L
Measured: At baseline and 6 weeks
Plasma interleukine 6
Plasma concentrations of IL-6 in pg/mL
Measured: At baseline and 6 weeks
Serum insulin
Serum concentrations of insulin in pg/mL
Measured: At baseline and 6 weeks
Body weight
Body weight in kg
Measured: At baseline and 6 weeks
Diastolic blood pressure
Diastolic blood pressure in mmHg
Measured: At baseline and 6 weeks
Serum creatinine
Serum concentrations of creatinine in g/L
Measured: At baseline and 6 weeks
Systolic blood pressure
Systolic blood pressure in mmHg
Measured: At baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome, Protection AgainstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Jan Frank, University of Hohenheim
- Investigators
- Jan Frank, Ph.D., Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925547
- Sponsor's protocol ID
- 0315679-HS3
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
- ClinicalTrials.gov ID
- NCT01925547
- Acronym / sponsor ID
- 0315679-HS3
- Conditions
- Metabolic Syndrome, Protection Against
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micellar curcumin | Experimental | Dietary Supplement: Micellar curcuminSubjects 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects receive three times per day four capsules of placebo preparation. At the beginning, after three and six weeks of intake, blood samples are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Total cholesterol > 5.2 mmol/L
- LDL cholesterol > 3.4 mmol/L
- Triglyceride > 2.26 mmol/L
- CRP > 2 mg/L
Key exclusion criteria (5 listed)
- Intake of drugs or dietary supplements
- Pregnant women and breastfeeding mothers
- Smokers
- Previous illnesses such as heart attack, cancer or dementia
- Addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micellar curcumin80 mg micellar curcumin (oral) three times a day for six weeks | Dietary supplement | Micellar curcumin |
| PlaceboOnly the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo. | Dietary supplement | Placebo |
Primary outcome
C-reactive protein (CRP)
Time frame: At baseline and 6 weeks
Serum CRP in mg/L
20 secondary outcomes
Plasma curcumin concentrations
Time frame: At baseline and 6 weeks
Serum alanine transaminase activity
Time frame: At baseline and 6 weeks
Fasting blood glucose
Time frame: At baseline and 6 weeks
Plasma tumor necrosis factor alpha
Time frame: At baseline and 6 weeks
Serum uric acid
Time frame: At baseline and 6 weeks
Plasma albumin
Time frame: At baseline and 6 weeks
Serum total cholesterol
Time frame: At baseline and 6 weeks
Serum triacylglycerols
Time frame: At baseline and 6 weeks
Serum HDL cholesterol
Time frame: At baseline and 6 weeks
Serum LDL cholesterol
Time frame: At baseline and 6 weeks
Serum aspartate transaminase activity
Time frame: At baseline and 6 weeks
Serum gamma glutamyl transferase activity
Time frame: At baseline and 6 weeks
Serum alkaline phosphatase activity
Time frame: At baseline and 6 weeks
Serum bilirubin
Time frame: At baseline and 6 weeks
Plasma interleukine 6
Time frame: At baseline and 6 weeks
Serum insulin
Time frame: At baseline and 6 weeks
Body weight
Time frame: At baseline and 6 weeks
Diastolic blood pressure
Time frame: At baseline and 6 weeks
Serum creatinine
Time frame: At baseline and 6 weeks
Systolic blood pressure
Time frame: At baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Results publication: PubMed 26909743Kocher 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Frank, Ph.D. principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micellar curcumin in people with Metabolic Syndrome, Protection Against, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (CRP) (time frame: At baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01925547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.