Metabolic SyndromeNCT01125501
Protandim and the Metabolic Syndrome
A study testing Protandim in people with Metabolic Syndrome, run by SomaLogic, Inc. at 1 site in United States.
Trial summary
Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Protandim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2010
- Phase
- Interventional
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age = 40-60 years of age
- Meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by NCEP/ATP III criteria)
- NCEP/ATP III criteria
- Central obesity as measured by waist circumference:
- Men - Greater than 40 inches
- Women - Greater than 35 inches
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- Fasting blood triglycerides greater than or equal to 150 mg/dL
- Blood HDL cholesterol:
- Men - Less than 40 mg/dL
- Women - Less than 50 mg/dL
- Blood pressure greater than or equal to 130/85 mmHg or on anti-hypertensive Rx
- Fasting glucose greater than or equal to 100 but < 125 mg/dL
Who cannot join
- Women taking hormone replacement therapy for post menopause
- Signs or symptoms of acute coronary syndrome
- History of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, EBCT calcium score of at least 100, or a positive stress test)
- Serum creatinine > 1.5 mg/dL, AST or ALT > 2 times ULN, HgA1c >6.5%, severely depressed or elevated blood cell lines, triglycerides > 500, TSH outside of normal range, elevated calcium, blood pressure > 160/100, urine protein > 30 ,g/dl.
- Concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes).
- Participation in any other investigational substance or medical device study within 30 days before this trial and/or participation in such entity during this trial.
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- Known pregnancy.
- Supplementation with nutraceuticals or if so one month washout before initiating the study before initiating this trial.
- Taking statins or fibrates to lower cholesterol
- Inability or unwillingness to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Protandim and the Metabolic Syndrome: A Preliminary Study to Define Protein Signatures That Change Along With Lowered Oxidative Stress Measured as F2 Isoprostanes or TBARS and Inflammation Measured as hsCRP
Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.
Read the detailed description
Evaluate the effects of Protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the Metabolic Syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Protandim
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtandimDietary supplement
The product Protandim used in this study have ingredients derived from five botanical sources [Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)].
| Study group | Role | What they receive |
|---|---|---|
| Protandim | Active comparator | one capsule a day for 30 days of protandim given, followed by a wash out period. Receives: Dietary Supplement: Protandim |
| Placebo | Placebo comparator | one capsule a day for 30 days will be given followed by a washout period. Receives: Dietary Supplement: Protandim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Decrease in Oxidative Stress markers.
the primary purpose of this trial is a preliminary study to examine the relationship to markers of oxidative stress,in response to Protandim, in Metabolic Syndrome.
Measured: every 30 days for 120 days
Secondary outcomes (1)
Protein signatures
evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome
Measured: every 30 days for 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SomaLogic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LifeVantage
- Investigators
- Robert H Eckel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125501
- Sponsor's protocol ID
- SomaL-028 (withdrawn)
- Status last verified
- Jul 2010
- First submitted
- 17 May 2010
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protandim and the Metabolic Syndrome: A Preliminary Study to Define Protein Signatures That Change Along With Lowered Oxidative Stress Measured as F2 Isoprostanes or TBARS and Inflammation Measured as hsCRP
- ClinicalTrials.gov ID
- NCT01125501
- Acronym / sponsor ID
- SomaL-028 (withdrawn)
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SomaLogic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- LifeVantage
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 18 May 2010 (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.
Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.
Detailed description
Evaluate the effects of Protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the Metabolic Syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protandim | Active comparator | Dietary Supplement: Protandimone capsule a day for 30 days of protandim given, followed by a wash out period. |
| Placebo | Placebo comparator | Dietary Supplement: Protandimone capsule a day for 30 days will be given followed by a washout period. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age = 40-60 years of age
- Meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by NCEP/ATP III criteria)
- NCEP/ATP III criteria
- Central obesity as measured by waist circumference:
- Fasting blood triglycerides greater than or equal to 150 mg/dL
Key exclusion criteria (10 listed)
- Women taking hormone replacement therapy for post menopause
- Signs or symptoms of acute coronary syndrome
- History of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, EBCT calcium score of at least 100, or a positive stress test)
- Serum creatinine > 1.5 mg/dL, AST or ALT > 2 times ULN, HgA1c >6.5%, severely depressed or elevated blood cell lines, triglycerides > 500, TSH outside of normal range, elevated calcium, blood pressure > 160/100, urine protein > 30 ,g/dl.
- Concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes).
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 |
|---|---|---|
| ProtandimThe product Protandim used in this study have ingredients derived from five botanical sources [Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)]. | Dietary supplement | Placebo, Protandim |
Primary outcome
Measure Decrease in Oxidative Stress markers.
Time frame: every 30 days for 120 days
the primary purpose of this trial is a preliminary study to examine the relationship to markers of oxidative stress,in response to Protandim, in Metabolic Syndrome.
1 secondary outcome
Protein signatures
Time frame: every 30 days for 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
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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.
Robert H Eckel, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protandim in people with Metabolic Syndrome, run by SomaLogic, Inc. at 1 site in United States.
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 12 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Oct 2017. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measure Decrease in Oxidative Stress markers. (time frame: every 30 days for 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2017.